The Interna*onal Liver Congress Amsterdam, Netherlands 22 April 2017

Size: px
Start display at page:

Download "The Interna*onal Liver Congress Amsterdam, Netherlands 22 April 2017"

Transcription

1 NGM282, a Novel Variant of FGF19, Significantly Reduces HepaAc Steatosis and Key Biomarkers of NASH: Results of a Phase 2, MulAcenter, Randomized, Double-Blinded, Placebo Controlled Trial in Biopsy-Confirmed NASH PaAents Stephen A. Harrison, Manal F. Abdelmalek, James F. TroRer, Angelo H. Paredes, Hays L. Arnold, Marcelo Kugelmas, Mustafa R. Bashir, Lei Ling, Stephen J. Rossi, Alex M. DePaoli, Mary E. Rinella, Rohit Loomba The Interna*onal Liver Congress Amsterdam, Netherlands 22 April 217

2 Disclosure InformaAon: Relevant Speaker Financial RelaAonships Dr. Stephen Harrison discloses the following relevant financial rela3onships with commercial interests within the past twelve months: Speakers Bureau: Alexion, Gilead Consultant, Advisory Board: Allergan, Chronic Liver Disease Founda3on, Cirius, Echosens, Fibrogen, Galmed, Genfit, Gilead, Intercept, Madrigal, NGM Bio, Novar3s, Perspectum, Pfizer Grant/Research Support: Allergan, Conatus, Galec3n, Galmed, Genfit, Gilead, Immuron, Intercept, Madrigal, NGM Bio, Taiwan J

3 FGF19 Has MulAple Biological AcAviAes Relevant to the Pathogenesis of NASH FGF19 Liver β-klotho FGFR4 β-klotho FGFR1c Insulin Sensi3vity De Novo Lipogenesis FaQy Acid Oxida3on LIVER Reduces Steatosis Reduces Lipotoxicity Reverses SteatohepaAAs Reduces Hepatocellular Injury Decreases Fibrogenesis Toxic FaQy Acids Free Cholesterol Bile Acids DAG/Ceramides

4 NGM282: A Novel Non-tumorigenic, Engineered Variant of Human FGF19 Over 15 variants screened to iden3fy molecules retaining the metabolic ac3vity of FGF19 while elimina3ng the tumorigenic effects Specific amino acid subs3tu3ons remove the IL6/STAT3 ac3va3on associated with FGF19 tumorigenicity Studied in mul3ple animal models of NASH with consistent ac3vity: Normaliza3on of liver enzymes Improvements in all components of NAS An3-fibro3c ac3vity No tumorigenicity Studied in over 275 subjects, including pa3ents with type 2 diabetes, PBC, PSC and NASH

5 Phase 2 Study of NGM282 in NASH: Overview of Study Design SCREENING ON-TREATMENT STUDY PERIOD FOLLOW-UP NGM282 Matched Placebo SC QD NGM282 3 mg SC QD NGM282 6 mg SC QD D -28 D1 W1 W2 W4 W8 W12 W16 - MRI-PDFF - Biopsy MRI-PDFF Randomized, double-blinded, placebo controlled trial Eighty-two subjects enrolled across 18 sites in Australia and the United States Biopsy confirmed NASH with a minimum NAS > 4 (1 point in each component) Stage 1, 2 or 3 fibrosis Minimum 8% absolute liver fat content by MRI-PDFF Abnormal ALT (> 19 IU/L in females; > 3 IU/L in males) Primary endpoint is a decrease in absolute liver fat content > 5%

6 Phase 2 Study of NGM282 in NASH: Baseline Demographics and CharacterisAcs Placebo (n=27) NGM282 3 mg (n=27) NGM282 6 mg (n=28) Mean age, years (SD) 52.8 (11.3) 52. (7.1) 56.4 (7.8) Male, n (%) 7 (25.9%) 11 (4.7) 12 (42.9) White, n (%) 25 (92.6) 25 (92.6) 24 (85.7) Hispanic/LaAno, n (%) 12 (44.4) 8 (29.6) 8 (28.6) DiabeAc, n (%) 17 (63.) 17 (63.) 17 (6.7) Mean weight, kg (SD) 97.6 (19.6) 95.3 (22.6) 98.4 (17.9) Mean BMI, kg/m² (SD) 35.4 (6.) 33.7 (8.6) 34.7 (5.6) Mean ALT, U/L (SD) 71 (42) 67 (54) 62 (34) Mean AST, U/L (SD) 59 (3) 5 (32) 43 (22) Mean MRI-PDFF, % (SD) 16.8 (6.7) 18.1 (7.3) 19.5 (7.8) Mean NAS, n (SD) 5.1 (1.1) 5.1 (1.) 5.1 (.9) Fibrosis stage 1 11 (4.7%) 11 (4.7%) 1 (35.7%) 2 7 (25.9%) 7 (25.9%) 12 (42.9%) 3 9 (33.3%) 9 (33.3%) 6 (21.4%)

7 NGM282 Treated Subjects had a 79% Response Rate with 34% Achieving Normal Liver Fat Content Response = Absolute decrease in liver fat content >5% at 12 weeks NormalizaAon = decrease in absolute liver fat content below 5% at 12 weeks % Response 4% % Placebo (n=27) Normal Abnormal 3 mg (n=27) Response No Response Placebo (.%) 27 (1.%) 3 mg 7 (25.9%) 2 (74.1%) 6 mg (n=26) 6 mg 11 (42.3%) 15 (57.7%) Baseline MRI-PDFF = 24.1% 4% % Week 12 MRI-PDFF = 3.6%

8 Primary Endpoint at Both Doses with Clinically Meaningful Changes in Liver Fat Content Absolute Change RelaAve Change -2 Placebo 3 mg 6 mg Placebo 3 mg 6 mg -1 Absolute Liver Fat (%) p = % Change in Liver Fat p = % of subjects achieved a clinically meaningful >3% rela?ve change Decreases in liver fat strongly correlate with reduc?ons in ALT, AST and C4

9 Greatest Magnitude of Effect in Subjects with Most AcAve Disease: Baseline MRI-PDFF >2% Absolute Change in Liver Fat Content (%) Mean ± SD p = p = % % Placebo (n=8) 3 mg (n=9) 6 mg (n=12) Baseline Wk 12/EW

10 Decreases in ALT at Week 12 Support ReducAons in InflammaAon Absolute Change Percentage Change Placebo 3 mg 6 mg Placebo 3 mg 6 mg ALT (U/L) % Change in ALT p =.951 p = % of subjects normalized ALT, the majority of these by Week 2

11 Rapid and Sustained ReducAons in ALT in PaAents with High Baseline Levels PaAents with a Baseline ALT > 6 U/L ALT (U/L) Placebo (n=11) 3 mg (n=11) 6 mg (n=12) Study Week

12 Decreases in Mean C4 Levels are ReflecAve of Potent CYP7A1 InhibiAon C4 at 24 hrs post-dose (ng/ml), Mean ± SD p = Placebo (n=27) 3 mg (n=27) 6. mg (n=28) Baseline Wk 12/EW 65% were below the LLQ (<.9 ng/ml) 24 hours post-dose at Week 12 C4 = 7α-hydroxy-4-cholesten-3-one

13 Decreased Triglyceride Levels are Consistent with NGM282 Mechanism of AcAon 35 p =.81 Triglycerides (mg/dl), Mean ± SD p=.825 p = Placebo (n=27) 3 mg (n=27) 6 mg (n=28) Baseline Wk 12/EW

14 Increased LDL Levels Reflect the Potent FGFR4-Mediated CYP7A1 InhibiAon 2 LDL-Cholesterol (mg/dl), Mean ± SD p = Placebo (n=27) 3 mg (n=27) 6 mg (n=28) Baseline Week 12 Preclinical and clinical data demonstrate a rapid miagaaon of increased LDL levels within 2 weeks with administraaon of a staan Luo et al. EASL ILC 217 Abstract FRI-353

15 Significant Decreases in PIIINP and TIMP-1 SupporAve of PotenAal AnA-fibroAc AcAvity Significant absolute and percentage change in total ELF score for 3 mg NGM282 cohort with numeric decreases observed with 6 mg cohort No significant changes observed in hyaluronic acid

16 Summary of the Most Common (> 1%) Treatment Emergent Adverse Events Placebo (N=27) ParAcipants (%) Events NGM282 3 mg (N=27) ParAcipants (%) Events NGM282 6 mg (N=28) ParAcipants (%) Events InjecAon site reacaons 2 (7.4%) 3 11 (4.7%) (53.6%) 27 Diarrhea/Loose stools 6 (22.2%) 6 11 (4.7%) 14 1 (35.7%) 13 Abdominal pain 2 (7.4%) 2 8 (29.6%) 9 5 (17.9%) 8 Nausea 1 (3.7%) 2 9 (33.3%) 11 4 (14.3%) 6 Headache 5 (18.5%) 6 3 (11.1%) 5 5 (17.9%) 5 Abdominal distension 1 (3.7%) 1 3 (11.1%) 3 4 (14.3%) 4 VomiAng (.%) 2 (7.4%) 2 5 (17.9%) 6 Frequent bowel movements 2 (7.4%) 2 3 (11.1%) 3 1 (3.6%) 1 Increased appeate (.%) 2 (7.4%) 2 4 (14.3%) 4 ConsApaAon 1 (3.7%) 1 3 (11.1%) 3 1 (3.6%) 1 InjecAon site bruising 3 (11.1%) 3 2 (7.4%) 2 (.%) Weight decreased (.%) (.%) 3 (1.7%) 3 The vast majority of TEAEs were Grade 1 One SAE during study period (acute pancreaaas, possibly related) Adverse event profile is predictable and consistent other NGM282-treated study populaaons

17 Changes in Key Safety and Tolerability Parameters Support ConAnued Development in NASH No significant changes in fas3ng blood glucose or insulin No evidence of renal, hepa3c or hematologic toxicity No evidence of steatorrhea or malabsorp3on secondary to decreased bile acid synthesis No detec3on of neutralizing an3bodies to NGM282 No evidence of drug-induced pruritus Significant weight reduc3on seen with 6 mg vs Placebo (-2.6 kg vs -.7, p =.23) but not at 3 mg dose Decrease in liver fat content appears independent of weight loss

18 Phase 2 Study of NGM282 in NASH PaAents: Summary and Next Steps Primary endpoint met in 79% of NGM282-treated subjects, with over one third of subjects normalizing liver fat content Significant and rapid reduc3ons in mul3ple markers that are relevant to the resolu3on of NASH and improvement in fibrosis No significant difference between 3 mg and 6 mg doses in the overall efficacy parameters; some differences in tolerability Adverse event profile is consistent with other NGM282-treated study popula3ons Further clinical studies are ongoing to evaluate lower doses of NGM282 and the use of sta3ns for mi3ga3on of LDL Data strongly supports con3nued development in NASH

19 Acknowledgements Stuart Roberts Marno Ryan Simone Strasser Jeyamani Ramachandran Manal Abdelmalek Hays Arnold Mustafa Bashir Stephen Caldwell Bradley Freilich Stephen Harrison Kris Kowdley Grisella LaSanta Rohit Loomba Guy Neff Angelo Paredes Mary Rinella Mitch Shiffman James TroQer Alex DePaoli Bryan Baxter Marie Fanget Sam Iki Lei Ling Jian Luo Prerna Menon Tom Parsons Van Phung Stephen Rossi Sandra Russell

EASL International Liver Congress Paris, France 14 April 2018

EASL International Liver Congress Paris, France 14 April 2018 NGM282 Improves Fibrosis and NASH-Related Histology in 12 Weeks in Patients With Biopsy-Confirmed NASH, Which is Preceded By Significant Decreases in Hepatic Steatosis, Liver Transaminases and Fibrosis

More information

2 nd International Workshop on NASH Biomarkers, Washington DC, May 5-6, 2017

2 nd International Workshop on NASH Biomarkers, Washington DC, May 5-6, 2017 Hepatic Proton Density Fat Fraction Correlates With Histologic Measures of Steatosis and Is Responsive to Changes in Those Measures in a Multi-center Nonalcoholic Steatohepatitis Clinical Trial Michael

More information

NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial

NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial Stephen A Harrison, Mary E Rinella, Manal F Abdelmalek, James F Trotter,

More information

Nonalcoholic Fatty Liver Disease in Children: Typical and Atypical

Nonalcoholic Fatty Liver Disease in Children: Typical and Atypical Nonalcoholic Fatty Liver Disease in Children: Typical and Atypical Disclosure Naim Alkhouri, MD discloses the following relationships with commercial companies: Membership in the Speakers Bureau for Alexion

More information

Overview of the Clinical Trial Data on Non-alcoholic Steatohepatitis (NASH)

Overview of the Clinical Trial Data on Non-alcoholic Steatohepatitis (NASH) Overview of the Clinical Trial Data on Non-alcoholic Steatohepatitis (NASH) Brent A. Neuschwander-Tetri, MD, FACP, FACG, AGAF, FAASLD Professor of Internal Medicine Director, Division of Gastroenterology

More information

Evercore ISI Presentation- Madrigal

Evercore ISI Presentation- Madrigal Evercore ISI Presentation- Madrigal Forward-Looking Statements Any statements, other than statements of historical facts, made in this presentation regarding our clinical studies and our research and development

More information

Update on Nonalcoholic Fatty Liver Disease. Kathleen E Corey, MD, MPH, MMSc Director, Mass General Fatty Liver Clinic

Update on Nonalcoholic Fatty Liver Disease. Kathleen E Corey, MD, MPH, MMSc Director, Mass General Fatty Liver Clinic Update on Nonalcoholic Fatty Liver Disease Kathleen E Corey, MD, MPH, MMSc Director, Mass General Fatty Liver Clinic Outline Defining the phenotypes of nonalcoholic fatty liver disease NAFLD Diagnostics

More information

NAFLD AND TYPE 2 DIABETES

NAFLD AND TYPE 2 DIABETES NAFLD AND TYPE 2 DIABETES Sonia Caprio, MD STOPNASH Symposium on the Origin and Pathways of Nonalcoholic Steatohepatitis Washington 7, 215 Global Projection of Diabetes Hossain P et al. N Engl J Med 27;356:213

More information

Oral Testosterone (T) Non Alcoholic Steatohepatitis (NASH)

Oral Testosterone (T) Non Alcoholic Steatohepatitis (NASH) Oral Testosterone (T) Non Alcoholic Steatohepatitis (NASH) 1 LPCN 1144: Well Positioned for Success Unique Mechanism of Action with Compelling Clinical Signal Targeting Full Spectrum of NASH Pathogenesis

More information

Improving the Lives of Patients with Liver Diseases

Improving the Lives of Patients with Liver Diseases Improving the Lives of Patients with Liver Diseases Corporate Presentation March 2019 Safe Harbor Statement This presentation contains "forward-looking" statements that involve risks, uncertainties and

More information

Company Overview. September 2018 NASDAQ: MDGL

Company Overview. September 2018 NASDAQ: MDGL Company Overview September 2018 NASDAQ: MDGL 1 Forward Looking Statements Any statements, other than statements of historical facts, made in this presentation regarding our future financial or business

More information

Madrigal s MGL-3196 Achieves Liver Biopsy Endpoints in Patients with Non-alcoholic Steatohepatitis (NASH) at 36 Weeks in Phase 2 Clinical Trial

Madrigal s MGL-3196 Achieves Liver Biopsy Endpoints in Patients with Non-alcoholic Steatohepatitis (NASH) at 36 Weeks in Phase 2 Clinical Trial Madrigal s MGL-3196 Achieves Liver Biopsy Endpoints in Patients with Non-alcoholic Steatohepatitis (NASH) at 36 Weeks in Phase 2 Clinical Trial -- Statistically significantly more patients treated with

More information

Non-alcoholic fatty liver disease: time to take note and manage. Philip Newsome Professor of Hepatology & Director of Centre for Liver Research

Non-alcoholic fatty liver disease: time to take note and manage. Philip Newsome Professor of Hepatology & Director of Centre for Liver Research Non-alcoholic fatty liver disease: time to take note and manage Philip Newsome Professor of Hepatology & Director of Centre for Liver Research Disclosures Consultancy, Co-ordinating Investigator roles

More information

Accepted Manuscript. S (18) Reference: JHEPAT To appear in: Journal of Hepatology

Accepted Manuscript. S (18) Reference: JHEPAT To appear in: Journal of Hepatology Accepted Manuscript Effect of NGM282, a FGF19 analogue, in Primary Sclerosing Cholangitis: a Multicentre, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial Gideon M. Hirschfield, Olivier Chazouillères,

More information

Cenicriviroc Treatment for Adults with Non-Alcoholic Steatohepatitis: Year 2 Analysis of the Phase 2b

Cenicriviroc Treatment for Adults with Non-Alcoholic Steatohepatitis: Year 2 Analysis of the Phase 2b Cenicriviroc Treatment for Adults with Non-Alcoholic Steatohepatitis: Year 2 Analysis of the Phase 2b CENTAUR Study Vlad Ratziu, Arun Sanyal, Sven Francque, Vincent Wai-Sun Wong, Rohit Loomba, Zachary

More information

Efficacy and Safety of Seladelpar in Primary Biliary Cholangitis 52-Week Analysis of a Dose-Ranging Phase 2 Study

Efficacy and Safety of Seladelpar in Primary Biliary Cholangitis 52-Week Analysis of a Dose-Ranging Phase 2 Study Efficacy and Safety of Seladelpar in Primary Biliary Cholangitis 52-Week Analysis of a Dose-Ranging Phase 2 Study Bowlus CL, Neff G, Aspinall R, Galambos M, Goel A, Hirschfield G, Kremer AE, Mayo MJ, Swain

More information

Update on Non-Alcoholic Fatty Liver Disease. Timothy R. Morgan, MD Chief, Hepatology, VA Long Beach Professor of Medicine, UCI

Update on Non-Alcoholic Fatty Liver Disease. Timothy R. Morgan, MD Chief, Hepatology, VA Long Beach Professor of Medicine, UCI Update on Non-Alcoholic Fatty Liver Disease Timothy R. Morgan, MD Chief, Hepatology, VA Long Beach Professor of Medicine, UCI February 3, 2018 Disclosure Clinical trials: Genfit Speaker s Bureau: none

More information

Yun-Jung Choi, Jiangao Song, Jeff D. Johnson, Charles McWherter. NASH-TAG Conference Park City, Utah January 4, 2019

Yun-Jung Choi, Jiangao Song, Jeff D. Johnson, Charles McWherter. NASH-TAG Conference Park City, Utah January 4, 2019 Combination Therapy of Seladelpar and Liraglutide Attenuates Obesity, Hepatic Steatosis and Fibrosis in a Diet-induced and Biopsy-confirmed Mouse Model of NASH Yun-Jung Choi, Jiangao Song, Jeff D. Johnson,

More information

Regulatory Updates Veronica Miller, PhD

Regulatory Updates Veronica Miller, PhD Regulatory Updates Veronica Miller, PhD Forum for Collaborative Research UC Berkeley SPH PARIS_NASH_2018 2 PARIS NASH 2018 Disclosures Dr. Veronica Miller is an employee of the Forum for Collaborative

More information

Non-invasive diagnostic biomarkers

Non-invasive diagnostic biomarkers Non-invasive diagnostic biomarkers Liver Forum, November 12 th, 2015 Rohit Loomba, MD, MHSc Professor of Medicine (with tenure) Director, NAFLD Research Center, Division of Gastroenterology, Department

More information

Amit Khatri, Sandeep Thomas Marbury, Richard A Preston, Lino Rodrigues, Haoyu Wang, Walid Awni, Rajeev Menon

Amit Khatri, Sandeep Thomas Marbury, Richard A Preston, Lino Rodrigues, Haoyu Wang, Walid Awni, Rajeev Menon The Pharmacokine.cs and Safety of the Direct Ac.ng An.viral Regimen of ABT- 450/r, Ombitasvir with/without Dasabuvir in Subjects with Mild, Moderate and Severe Renal Impairment Compared to Subjects with

More information

Corporate Presentation

Corporate Presentation Corporate Presentation November, 2018 Forward-Looking Statements This presentation contains statements about our future expectations, plans and prospects that constitute forward-looking statements for

More information

Obesity Comorbidi.es: It s About Your Health, Not Your Weight. Elizabeth Estrada, MD Pediatric Endocrinology

Obesity Comorbidi.es: It s About Your Health, Not Your Weight. Elizabeth Estrada, MD Pediatric Endocrinology Obesity Comorbidi.es: It s About Your Health, Not Your Weight Elizabeth Estrada, MD Pediatric Endocrinology Conflict of Interest NOTHING TO DISCLOSE Objec.ves 1. Recognize the most common comorbidi.es

More information

NASH UPDATE ON DIAGNOSTICS AND THERAPY. Arun J Sanyal MBBS, MD Virginia Commonwealth University School of Medicine

NASH UPDATE ON DIAGNOSTICS AND THERAPY. Arun J Sanyal MBBS, MD Virginia Commonwealth University School of Medicine NASH UPDATE ON DIAGNOSTICS AND THERAPY Arun J Sanyal MBBS, MD Virginia Commonwealth University School of Medicine Conflicts of interest Salaried employee: of VCU Member of Board: McGuire VA Research Institute,

More information

Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule Insert (TX-004HR) in Menopausal Women with Moderate to Severe Dyspareunia

Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule Insert (TX-004HR) in Menopausal Women with Moderate to Severe Dyspareunia Evaluation of Systemic Effects of a Vaginal Estradiol Softgel Capsule Insert (TX-4HR) in Menopausal Women with Moderate to Severe Dyspareunia Lisa Larkin, MD 1 ; Andrew M Kaunitz, MD 2 ; James Liu, MD

More information

Therapy for NAFLD Are we getting there? Sanjay Bhagani Royal Free London/UCL

Therapy for NAFLD Are we getting there? Sanjay Bhagani Royal Free London/UCL Therapy for NAFLD Are we getting there? Sanjay Bhagani Royal Free London/UCL What is NAFLD? Non-Alcoholic Fatty Liver Disease Wide disease range from simple steatosis to cirrhosis Steatosis Steatosis/inflammation

More information

Con$nuing Care for Your Pa$ents with Metasta$c CRPC

Con$nuing Care for Your Pa$ents with Metasta$c CRPC 27 th Annual InternaAonal Prostate Cancer Symposium Update January 26, 2017 Con$nuing Care for Your Pa$ents with Metasta$c CRPC Michael S. Cookson, MD, MMHC Professor and Chair Department of Urology University

More information

SYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779)

SYNOPSIS OF RESEARCH REPORT (PROTOCOL BC20779) TITLE OF THE STUDY / REPORT No. / DATE OF REPORT INVESTIGATORS / CENTERS AND COUNTRIES Clinical Study Report Protocol BC20779: Multicenter, double-blind, randomized, placebo-controlled, dose ranging phase

More information

Ocaliva (obeticholic acid tablets)

Ocaliva (obeticholic acid tablets) Ocaliva (obeticholic acid tablets) Policy Number: 5.01.619 Last Review: 11/2018 Origination: 11/2016 Next Review: 11/2019 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage

More information

Disclosure. This study was sponsored by Pfizer, Inc. All authors are employees of Pfizer, Inc. with ownership of stock in Pfizer, Inc.

Disclosure. This study was sponsored by Pfizer, Inc. All authors are employees of Pfizer, Inc. with ownership of stock in Pfizer, Inc. Disclosure This study was sponsored by Pfizer, Inc. All authors are employees of Pfizer, Inc. with ownership of stock in Pfizer, Inc. Effects of 12 Weeks of Treatment with RN316 (PF-04950615), a Humanized

More information

IMPACT OF HCV THERAPY ON METABOLISM AND PUBLIC HEALTH

IMPACT OF HCV THERAPY ON METABOLISM AND PUBLIC HEALTH IMPACT OF HCV THERAPY ON METABOLISM AND PUBLIC HEALTH Mitchell L Shiffman, MD Director Health System Richmond and Newport News, VA Medical Group Good Help to Those in Need DISCLOSURES CONFLICTS OF INTEREST

More information

Company Overview. June 2018 NASDAQ: MDGL

Company Overview. June 2018 NASDAQ: MDGL Company Overview June 2018 NASDAQ: MDGL 1 Forward Looking Statements Any statements, other than statements of historical facts, made in this presentation regarding our future financial or business performance,

More information

Kevin Fitzgerald, PhD

Kevin Fitzgerald, PhD A Subcutaneously Administered Investigational RNAi Therapeutic (ALN-PCSsc), Targeting PCSK9 for the Treatment of Hypercholesterolemia: Initial Phase 1 Study Results Kevin Fitzgerald, PhD Co-authors: Amy

More information

NAFLD ENDPOINTS CONFERENCE

NAFLD ENDPOINTS CONFERENCE AASLD/EASL NAFLD ENDPOINTS CONFERENCE June 29 30, 2018 The Westin Alexandria Alexandria, VA Program Chairs: Arun J. Sanyal, MBBS, MD, FAASLD Mary E. McCarthy Rinella, MD, FAASLD Quentin M. Anstee, MBBS,

More information

Study Design to Validate Biomarkers of Therapeutic Response in Pre-cirrhotic NASH

Study Design to Validate Biomarkers of Therapeutic Response in Pre-cirrhotic NASH Study Design to Validate Biomarkers of Therapeutic Response in Pre-cirrhotic NASH Brent A. Neuschwander-Tetri, MD, FAASLD Professor of Internal Medicine Director, Division of Gastroenterology and Hepatology

More information

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI.

PFIZER INC. THERAPEUTIC AREA AND FDA APPROVED INDICATIONS: See USPI. PFIZER INC. These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert. For publications based on this study, see associated bibliography.

More information

Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies

Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies Efficacy, Safety and Tolerability of 150 mg Q2W Dose of the PCSK9 mab REGN727/SAR236553: Data from Three Phase 2 Studies Michael J. Koren, 1 Evan A. Stein, 2 Eli M. Roth, 3 James M. McKenney, 4 Dan Gipe,

More information

At Least 1 in 5 Patients in Your Practice Have Fatty Liver

At Least 1 in 5 Patients in Your Practice Have Fatty Liver At Least 1 in 5 Patients in Your Practice Have Fatty Liver What Can You Tell Your Patients Magnus McLeod MD FRCPC Assistant Professor Dalhousie University 30-NOV-2017 NAFLD Non-Alcoholic Fatty Liver Disease

More information

Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS)

Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS) Canakinumab Anti-Inflammatory Thrombosis Outcomes Study (CANTOS) Stable CAD (post MI) On Statin, ACE/ARB, BB, ASA Persistent Elevation of hscrp (> 2 mg/l) N = 10,061 39 Countries April 2011 - June 2017

More information

9/3/ AHA/ACC Lipid Guidelines on the Treatment of Cholesterol to Reduce Atherosclerosis. Disclosure

9/3/ AHA/ACC Lipid Guidelines on the Treatment of Cholesterol to Reduce Atherosclerosis. Disclosure 2013 AHA/ACC Lipid Guidelines on the Treatment of Cholesterol to Reduce Atherosclerosis Robert Gleeson MD Preven5ve Cardiology and Lipid Management Froedtert and The Medical College of Wisconsin Disclosure

More information

Supplementary Appendix

Supplementary Appendix Supplementary Appendix This appendix has been provided by the authors to give readers additional information about their work. Supplement to: Kowdley KV, Gordon SC, Reddy KR, et al. Ledipasvir and sofosbuvir

More information

Clinical Impact of New Data From the 2017 Washington, DC, Hepatology Meeting

Clinical Impact of New Data From the 2017 Washington, DC, Hepatology Meeting Clinical Impact of New Data From the 2017 Washington, DC, Hepatology Meeting CCO Independent Conference Coverage* of the 2017 American Association for the Study of Liver Diseases, October 20-24, 2017;

More information

WHAT THE EXPERIMENTAL MODELS CAN TEACH US IN NAFLD/NASH? Claudio Tiribelli, MD PhD Scientific Director FIF

WHAT THE EXPERIMENTAL MODELS CAN TEACH US IN NAFLD/NASH? Claudio Tiribelli, MD PhD Scientific Director FIF WHAT THE EXPERIMENTAL MODELS CAN TEACH US IN NAFLD/NASH? Claudio Tiribelli, MD PhD Scientific Director FIF ctliver@fegato.it Worldwide estimated prevalence of NAFLD distribution of PNPLA3 genotypes 2017-Younussi

More information

Zafgen PWS Clinical Trial Program Overview. November 16, 2014

Zafgen PWS Clinical Trial Program Overview. November 16, 2014 Zafgen PWS Clinical Trial Program Overview November 16, 2014 2 Disclaimers Forward Looking Statements These slides and the accompanying oral presentation contain forward-looking statements and information.

More information

Sponsor Novartis. Generic Drug Name Vildagliptin/Metformin. Therapeutic Area of Trial Type 2 diabetes. Approved Indication Type 2 diabetes

Sponsor Novartis. Generic Drug Name Vildagliptin/Metformin. Therapeutic Area of Trial Type 2 diabetes. Approved Indication Type 2 diabetes Clinical Trial Results Database Page 1 Sponsor Novartis Generic Drug Name Vildagliptin/Metformin Therapeutic Area of Trial Type 2 diabetes Approved Indication Type 2 diabetes Study Number CLMF237A2309

More information

Non-Alcoholic Fatty Liver Diseasean underestimated epidemic

Non-Alcoholic Fatty Liver Diseasean underestimated epidemic Non-Alcoholic Fatty Liver Diseasean underestimated epidemic Amir Shlomai MD,PhD Head, Department of Medicine D The Liver Institute Rabin Medical Center, Beilinson Hospital The IASLD semi-annual meeting-

More information

Efficacy and Safety of Alirocumab in Patients with Hypercholesterolemia not on Statin Therapy: the ODYSSEY CHOICE II Study

Efficacy and Safety of Alirocumab in Patients with Hypercholesterolemia not on Statin Therapy: the ODYSSEY CHOICE II Study Efficacy and Safety of Alirocumab in Patients with Hypercholesterolemia not on Statin Therapy: the ODYSSEY CHOICE II Study Erik Stroes, 1 John Guyton, 2 Michel Farnier, 3 Norman Lepor, 4 Fernando Civeira,

More information

Lipid and Bile Acids as NAFLD- Related Biomarkers

Lipid and Bile Acids as NAFLD- Related Biomarkers Lipid and Bile Acids as NAFLD- Related Biomarkers Puneet Puri, MBBS, MD Division of Gastroenterology, Hepatology and Nutrition Virginia Commonwealth University, Richmond, VA 1st International Workshop

More information

Dietary supplementation in treating non-alcoholic fatty liver disease Dr. Ahmad Saedi Associate Professor School of Nutritional Sciences and

Dietary supplementation in treating non-alcoholic fatty liver disease Dr. Ahmad Saedi Associate Professor School of Nutritional Sciences and Dietary supplementation in treating non-alcoholic fatty liver disease Dr. Ahmad Saedi Associate Professor School of Nutritional Sciences and Dietetics Tehran University of Medical Sciences Honorary Academic

More information

METABOLIC SYNDROME DONALD FELITTO, M.D.

METABOLIC SYNDROME DONALD FELITTO, M.D. METABOLIC SYNDROME DONALD FELITTO, M.D. DEFINITIONS WHO Defini:on 1999 Diabetes or impaired fas/ng glycemia or IGT or insulin resistance Plus any two: Obesity: BMI > 30, WTH ra/o>0.9 male or >0.85 female.

More information

SYNOPSIS 2/198 CSR_BDY-EFC5825-EN-E02. Name of company: TABULAR FORMAT (For National Authority Use only)

SYNOPSIS 2/198 CSR_BDY-EFC5825-EN-E02. Name of company: TABULAR FORMAT (For National Authority Use only) SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, parallel-group, fixed-dose (rimonabant 20 mg) multicenter study of long-term glycemic control with rimonabant in treatment-naïve

More information

Proof-of-Concept Phase-2a Clinical Trial of ANB020 (Anti-IL-33 Antibody) in the Treatment of Moderate-to-Severe Adult Atopic Dermatitis

Proof-of-Concept Phase-2a Clinical Trial of ANB020 (Anti-IL-33 Antibody) in the Treatment of Moderate-to-Severe Adult Atopic Dermatitis Proof-of-Concept Phase-2a Clinical Trial of ANB020 (Anti-IL-33 Antibody) in the Treatment of Moderate-to-Severe Adult Atopic Dermatitis Professor Graham Ogg University of Oxford United Kingdom European

More information

Madrigal Pharmaceuticals, Inc.

Madrigal Pharmaceuticals, Inc. Madrigal Pharmaceuticals, Inc. NASDAQ: MDGL 1 Forward-Looking Statements Any statements, other than statements of historical facts, made in this presentation regarding our future financial or business

More information

Diagnosis and Management of PBC

Diagnosis and Management of PBC Diagnosis and Management of PBC Cynthia Levy, MD, FAASLD University of Miami Miller School of Medicine Miami, Florida 1 Primary Biliary Cholangitis (PBC) Chronic cholestatic liver disease Autoimmune in

More information

NASH Bench to Bedside

NASH Bench to Bedside NASH Bench to Bedside October 2006 Anna Mae Diehl, M.D. Gastroenterology Division Duke University NonAlcoholic Fatty Liver Disease Common ~1/4-1/3 1/3 US adults Outcome highly variable Course indolent

More information

Individual Study Table Referring to Part of the Dossier. Use only) Name of Finished Product:

Individual Study Table Referring to Part of the Dossier. Use only) Name of Finished Product: SYNOPSIS Fresenius Title of the study: A double-blind, randomized study comparing the safety and torelance of SMOFlipid 20% and Intralipid 20% in long-term treatment with parenteral nutrition Coordinating

More information

Safety of Anacetrapib in Patients with or

Safety of Anacetrapib in Patients with or Safety of Anacetrapib in Patients with or at Risk for Coronary Heart Disease Christopher P. Cannon, MD, Sukrut Shah, PhD, RPh, Hayes M. Dansky, MD, Michael Davidson, MD, Eliot A. Brinton, MD, Antonio M.

More information

Fat, ballooning, plasma cells and a +ANA. Yikes! USCAP 2016 Evening Specialty Conference Cynthia Guy

Fat, ballooning, plasma cells and a +ANA. Yikes! USCAP 2016 Evening Specialty Conference Cynthia Guy Fat, ballooning, plasma cells and a +ANA. Yikes! USCAP 2016 Evening Specialty Conference Cynthia Guy Goals Share an interesting case Important because it highlights a common problem that we re likely to

More information

A pathologist, a radiologist and a hepatologist walked into a bar

A pathologist, a radiologist and a hepatologist walked into a bar A pathologist, a radiologist and a hepatologist walked into a bar Brent A. Neuschwander-Tetri, MD, FAASLD Professor of Internal Medicine Director, Division of Gastroenterology and Hepatology Saint Louis

More information

Primary biliary cholangitis, previously called

Primary biliary cholangitis, previously called Hepatology Communications, VOL. 0, NO.0, 2018 NGM282 for Treatment of Patients With Primary Biliary Cholangitis: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Marlyn J. Mayo, 1 Alan

More information

Efficacy and safety of brexpiprazole for the treatment of acute. schizophrenia: a 6-week, randomized, double-blind, placebocontrolled

Efficacy and safety of brexpiprazole for the treatment of acute. schizophrenia: a 6-week, randomized, double-blind, placebocontrolled Supplementary material Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia: a 6-week, randomized, double-blind, placebocontrolled trial Christoph U. Correll, M.D. 1, Aleksandar

More information

NAFLD: evidence-based management. Curso de residentes AEEH Salvador Augustin, MD Liver Unit Vall d Hebron Hospital Barcelona, Spain

NAFLD: evidence-based management. Curso de residentes AEEH Salvador Augustin, MD Liver Unit Vall d Hebron Hospital Barcelona, Spain NAFLD: evidence-based management Curso de residentes AEEH 2017 Salvador Augustin, MD Liver Unit Vall d Hebron Hospital Barcelona, Spain Clinical case - 55 yo female - Sent for incidental steatosis at abdominal

More information

Daniel Canafax, PharmD VP, Clinical Research Theravance, Inc.

Daniel Canafax, PharmD VP, Clinical Research Theravance, Inc. Demonstrates Improvement in Bowel Movement Frequency and Bristol Stool Scores in a Phase 2b Study of Patients with Opioid-Induced Constipation (OIC) Ross Vickery, PhD, 1 Yu-Ping Li, PhD, 1 Ullrich Schwertschlag,

More information

Study Code: Date: 27 July 2007

Study Code: Date: 27 July 2007 These results are supplied for informational purposes only. Prescribing decisions should be made based on the approved package insert in the country of prescription Sponsor/company: Generic drug name:

More information

Safety, Tolerability and Target Engagement Demonstrated in Phase 1 Study of LRRK2 Inhibitor DNL201 in Healthy Young and Elderly Adults

Safety, Tolerability and Target Engagement Demonstrated in Phase 1 Study of LRRK2 Inhibitor DNL201 in Healthy Young and Elderly Adults Safety, Tolerability and Target Engagement Demonstrated in Phase 1 Study of LRRK2 Inhibitor DNL201 in Healthy Young and Elderly Adults MJFF Parkinson s Disease Therapeutics Conference October 25, 2018

More information

APDW 2016 Poster No. a90312

APDW 2016 Poster No. a90312 APDW 2016 Poster No. a90312 SYN-010, a Proprietary Modified-Release Formulation of Lovastatin Lactone, Lowered Breath Methane and Improved Stool Frequency in Patients with IBS-C Results of a multi-center,

More information

Mipomersen (ISIS ) Page 2 of 1979 Clinical Study Report ISIS CS3

Mipomersen (ISIS ) Page 2 of 1979 Clinical Study Report ISIS CS3 (ISIS 301012) Page 2 of 1979 2 SYNOPSIS ISIS 301012-CS3 synopsis Page 1 Title of Study: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics,

More information

Supplementary Online Content

Supplementary Online Content Supplementary Online Content Larsen JR, Vedtofte L, Jakobsen MSL, et al. Effect of liraglutide treatment on prediabetes and overweight or obesity in clozapine- or olanzapine-treated patients with schizophrenia

More information

Study Design to Validate Biomarkers of Therapeutic Response in NASH Due to Cirrhosis

Study Design to Validate Biomarkers of Therapeutic Response in NASH Due to Cirrhosis Study Design to Validate Biomarkers of Therapeutic Response in NASH Due to Cirrhosis Detlef Schuppan Institute of Translational Immunology and Research Center for Immune Therapy, University Medical Center

More information

NONALCOHOLIC FATTY LIVER DISEASE. Non-Alcoholic Fatty Liver Disease (NAFLD) Primary NAFLD. April 13, 2012

NONALCOHOLIC FATTY LIVER DISEASE. Non-Alcoholic Fatty Liver Disease (NAFLD) Primary NAFLD. April 13, 2012 NONALCOHOLIC FATTY LIVER DISEASE Kiran Bambha, MD University of Colorado Denver April 13, 2012 Non-Alcoholic Fatty Liver Disease (NAFLD) Primary NAFLD Simple Steatosis Fatty hepatocytes Intracellular fat

More information

(For National Authority Use Only) Name of Study Drug: to Part of Dossier:

(For National Authority Use Only) Name of Study Drug: to Part of Dossier: 2.0 Synopsis Abbott Laboratories Individual Study Table Referring to Part of Dossier: (For National Authority Use Only) Name of Study Drug: Volume: ABT-335 Name of Active Ingredient: Page: ABT-335, A-7770335.115

More information

NON-ALCOHOLIC FATTY LIVER DISEASE:

NON-ALCOHOLIC FATTY LIVER DISEASE: NON-ALCOHOLIC FATTY LIVER DISEASE: ROLE OF THE PRIMARY PROVIDER Archita P. Desai, MD Assistant Professor of Medicine University of Arizona 25 th Annual Southwestern Conference on Medicine Outline Pathophysiology

More information

ALN-PCSsc, an RNAi Investigational Agent That Inhibits PCSK9 Synthesis With the Potential for Effective Bi-Annual Dosing: Interim Results

ALN-PCSsc, an RNAi Investigational Agent That Inhibits PCSK9 Synthesis With the Potential for Effective Bi-Annual Dosing: Interim Results ALN-PCSsc, an RNAi Investigational Agent That Inhibits PCSK9 Synthesis With the Potential for Effective Bi-Annual Dosing: Interim Results Kevin Fitzgerald, PhD Co-authors: Amy Simon 1, Suellen White 1,

More information

ABNORMAL LIVER FUNCTION TESTS. Dr Uthayanan Chelvaratnam Hepatology Consultant North Bristol NHS Trust

ABNORMAL LIVER FUNCTION TESTS. Dr Uthayanan Chelvaratnam Hepatology Consultant North Bristol NHS Trust ABNORMAL LIVER FUNCTION TESTS Dr Uthayanan Chelvaratnam Hepatology Consultant North Bristol NHS Trust INTRODUCTION Liver function tests Cases Non invasive fibrosis measurement Questions UK MORTALITY RATE

More information

XP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED.

XP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED. XP23829 PHASE 2 PSORIASIS TRIAL PRELIMINARY TOPLINE DATA PRESENTATION SEPTEMBER 15, 2015 COPYRIGHT 2015 XENOPORT, INC. ALL RIGHTS RESERVED. SAFE HARBOR DISCLAIMER These slides and the accompanying oral

More information

Pre-diabetes. Pharmacological Approaches to Delay Progression to Diabetes

Pre-diabetes. Pharmacological Approaches to Delay Progression to Diabetes Pre-diabetes Pharmacological Approaches to Delay Progression to Diabetes Overview Definition of Pre-diabetes Risk Factors for Pre-diabetes Clinical practice guidelines for diabetes Management, including

More information

Phase 2 placebo-controlled withdrawal study of the ASBT inhibitor maralixibat in children with Alagille syndrome 48-week efficacy analysis

Phase 2 placebo-controlled withdrawal study of the ASBT inhibitor maralixibat in children with Alagille syndrome 48-week efficacy analysis Phase 2 placebo-controlled withdrawal study of the ASBT inhibitor maralixibat in children with Alagille syndrome 48-week efficacy analysis ICONIC Study Emmanuel Gonzales, Ekkehard Sturm, Michael Stormon,

More information

Anne Carol Goldberg, MD, FACP, FAHA, FNLA Washington University, St. Louis, MO USA

Anne Carol Goldberg, MD, FACP, FAHA, FNLA Washington University, St. Louis, MO USA Efficacy and Safety of Bempedoic Acid Added to Maximally Tolerated Statins in Patients with Hypercholesterolemia and High Cardiovascular Risk: The CLEAR Wisdom Trial Anne Carol Goldberg, MD, FACP, FAHA,

More information

SYNOPSIS. Administration: subcutaneous injection Batch number(s):

SYNOPSIS. Administration: subcutaneous injection Batch number(s): SYNOPSIS Title of the study: A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter 24-week study followed by an extension assessing the efficacy and safety of AVE0010 on top

More information

Prevalence of non-alcoholic fatty liver disease in type 2 diabetes mellitus patients in a tertiary care hospital of Bihar

Prevalence of non-alcoholic fatty liver disease in type 2 diabetes mellitus patients in a tertiary care hospital of Bihar Original Research Article Prevalence of non-alcoholic fatty liver disease in type 2 diabetes mellitus patients in a tertiary care hospital of Bihar Naresh Kumar 1, Jyoti Kumar Dinkar 2*, Chandrakishore

More information

Seladelpar Interim Data Phase 2 Low Dose Study in PBC. July 17, 2017

Seladelpar Interim Data Phase 2 Low Dose Study in PBC. July 17, 2017 Seladelpar Interim Data Phase 2 Low Dose Study in PBC July 17, 2017 Seladelpar Phase 2 Low Dose Study in PBC Potential for superior efficacy and better tolerability 39% (5 mg) and 45% (10 mg) reductions

More information

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable:

Study No.: Title: Rationale: Phase: Study Period: Study Design: Centres: Indication: Treatment: Objectives: Primary Outcome/Efficacy Variable: The study listed may include approved and non-approved uses, formulations or treatment regimens. The results reported in any single study may not reflect the overall results obtained on studies of a product.

More information

NASH PROGRESS IN THE LAST DECADE

NASH PROGRESS IN THE LAST DECADE PROGRESS IN THE LAST DECADE Mitchell L. Shiffman, MD, FACG Director Health System Richmond and Newport News, VA Medical Group Good Help to Those in Need A GLOBAL HEALTH PROBLEM Nigeria Australia Spain

More information

AESOP Overview and Inclusion/Exclusion Criteria Richard Pencek, PhD

AESOP Overview and Inclusion/Exclusion Criteria Richard Pencek, PhD 747-207 AESOP Overview and Inclusion/ Criteria Richard Pencek, PhD Sr Director, Clinical Research, Intercept Pharmaceuticals, Inc. 2 PSC Forum 2 AESOP: A Phase 2 Randomized, Placebo-Controlled Trial, Dose-Finding

More information

Pancreatic exocrine insufficiency: a rare cause of nonalcoholic steatohepatitis

Pancreatic exocrine insufficiency: a rare cause of nonalcoholic steatohepatitis Pancreatic exocrine insufficiency: a rare cause of nonalcoholic steatohepatitis Naoki Tanaka 1, Akira Horiuchi 2, Takahide Yokoyama 3, Shigeyuki Kawa 1, and Kendo Kiyosawa 1 1 Department of Gastroenterology,

More information

12th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) 28 September 2016

12th Annual Meeting of the Oligonucleotide Therapeutics Society (OTS) 28 September 2016 A Randomized, Single-Blind, Placebo-Controlled, Phase /2 Study of ALN-AAT, an Investigational RNAi Therapeutic for the Treatment of Alpha- Antitrypsin Deficiency Associated Liver Disease: Interim Study

More information

Emricasan (IDN-6556) administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension

Emricasan (IDN-6556) administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension Emricasan (IDN-6556) administered orally for 28 days lowers portal pressure in patients with compensated cirrhosis and severe portal hypertension Guadalupe Garcia-Tsao, Michael Fuchs, Mitchell Shiffman,

More information

NONALCOHOLIC STEATOHEPATITIS (NASH) - OPPORTUNITY ANALYSIS AND FORECASTS TO EVENT-DRIVEN UPDATE

NONALCOHOLIC STEATOHEPATITIS (NASH) - OPPORTUNITY ANALYSIS AND FORECASTS TO EVENT-DRIVEN UPDATE REFERENCE CODE GDHC034POA PUBLICAT ION DATE MARCH 2014 NONALCOHOLIC STEATOHEPATITIS (NASH) - - EVENT-DRIVEN UPDATE Executive Summary NASH: Key Metrics in Six Major Pharmaceutical Markets 2012 Epidemiology

More information

Fatty Liver Disease. Mark Thursz. Imperial College

Fatty Liver Disease. Mark Thursz. Imperial College Fatty Liver Disease Mark Thursz Imperial College Non-Alcoholic Fatty Liver Disease UK adult obesity (BMI>30) 1980: 6% [M], 8% [F]. 1997: 17% [M], 20% [F]. By 2004, 23.6% of men and 23.8% of women were

More information

Can Study Protocols Protect Patients with Liver Diseases from Serious DILI?

Can Study Protocols Protect Patients with Liver Diseases from Serious DILI? Can Study Protocols Protect Patients with Liver Diseases from Serious DILI? Serious DILI John M Vierling, MD, FACP, FAASLD Professor of Medicine and Surgery Chief of Hepatology Director of Baylor Liver

More information

Lipid- Lowering Medica0ons. Drugs for Med Students Presented by Eric Campbell & Jen Chen

Lipid- Lowering Medica0ons. Drugs for Med Students Presented by Eric Campbell & Jen Chen Lipid- Lowering Medica0ons Drugs for Med Students Presented by Eric Campbell & Jen Chen Rela0ve Effects of Lipid- Lowering Medica0ons Drug LDL HDL TG Sta0ns Fenofibrate Niacin Resins * Eze0mibe *Bile acid

More information

Fatty Liver Disease A growing epidemic

Fatty Liver Disease A growing epidemic Fatty Liver Disease A growing epidemic Updates in GIM for Primary Care Don C. Rockey March 9 th, 2018 Disclosures 2018 Research Funding (all to MUSC) NIH/NIDDK Actelion Pharmaceuticals Gilead Sciences

More information

Novel multiparametric magnetic resonance elastography (MRE) protocol accurately predicts NAS score for NASH diagnosis

Novel multiparametric magnetic resonance elastography (MRE) protocol accurately predicts NAS score for NASH diagnosis Novel multiparametric magnetic resonance elastography (MRE) protocol accurately predicts NAS score for NASH diagnosis Alina M. Allen, Meng Yin, Sudhakar K. Venkatesh, Taofic Mounajjed, Todd A. Kellogg,

More information

Inarigivir: A novel RIG-I agonist for chronic hepatitis B

Inarigivir: A novel RIG-I agonist for chronic hepatitis B : A novel RIG-I agonist for chronic hepatitis B Stephen Locarnini, Danny Wong, Kathy Jackson, Renae Walsh, Ros Edwards, Rachel Hammond, Carla S. Coffin, Magdy Elkhashab, Susan Greenbloom, Alnoor Ramji,

More information

tage Percent Total & over Total & over Men Women Men Women

tage Percent Total & over Total & over Men Women Men Women Paul Angulo, MD, FACG, AGAF Professor of Medicine, Section Chief of Hepatology Division i i of Digestive i Diseases and Nutrition i University of Kentucky Medical Center Lexington, KY Paul Angulo, MD University

More information

The Impact of HBV Therapy on Fibrosis and Cirrhosis

The Impact of HBV Therapy on Fibrosis and Cirrhosis The Impact of HBV Therapy on Fibrosis and Cirrhosis Jordan J. Feld, MD, MPH Associate Professor of Medicine University of Toronto Hepatologist Toronto Centre for Liver Disease Sandra Rotman Centre for

More information

Acute Hepatitis in a Patient with NASH and Elevation of CMV-IgM

Acute Hepatitis in a Patient with NASH and Elevation of CMV-IgM Acute Hepatitis in a Patient with NASH and Elevation of CMV-IgM Uta Drebber, MD Disclosure of Relevant Financial Relationships USCAP requires that all faculty in a position to influence or control the

More information

SYNOPSIS Final Clinical Study Report for Study AI444031

SYNOPSIS Final Clinical Study Report for Study AI444031 Name of Sponsor/Company: Bristol-Myers Squibb Name of Finished Product: Name of Active Ingredient: () Individual Study Table Referring to the Dossier (For National Authority Use Only) SYNOPSIS for Study

More information

March 30, 2014, Joint ACC/JAMA Late-breaking Clinical Trials Session 402 American College of Cardiology, Washington DC

March 30, 2014, Joint ACC/JAMA Late-breaking Clinical Trials Session 402 American College of Cardiology, Washington DC A Phase 3 Double-blind, Randomized Study to Assess Safety and Efficacy of Evolocumab (AMG 145) in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of Statin Erik Stroes 1, David Colquhoun

More information