Clinical trials: NAFLD and NASH
NASH, NASH - Nonalcoholic Steatohepatitis
Study to Evaluate MET409 Alone or in Combination With Empagliflozin in Patients With Type 2 Diabetes and NASH
A randomized, multi-center study evaluating MET409 (50 mg) alone or in combination with empagliflozin (10 mg) for 12 weeks. Assignment to MET409 will be double-blind and placebo-controlled.
- Conditions
- NASH, NASH - Nonalcoholic Steatohepatitis, Type 2 Diabetes, Diabetes Type 2
- Trial name
- NCT04702490
- Testing
- MET409 Active, Empagliflozin
- Where
- 2 sites in United States
- Volunteers
- 120 people
- Sponsor
- Metacrine, Inc.
Non-alcoholic Steatohepatitis (NASH)
A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients
This study is intended to investigate the safety and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AZD2693, following subcutaneous (SC) administration of multiple ascending doses in participants with…
- Trial name
- NCT04483947
- Testing
- AZD2693
- Where
- 16 sites in United States
- Volunteers
- 74 people
- Sponsor
- AstraZeneca
Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)
Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic…
- Trial name
- NCT02781584
- Testing
- SEL, FIR, CILO
- Where
- 13 sites in United States, New Zealand
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Phase 2a, Dose-ranging Study With PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
Phase 2a, dose-ranging Study with PF-05221304 in Nonalcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT03248882
- Testing
- PF-05221304
- Where
- 140 sites in United States, Australia and 4 more
- Volunteers
- 305 people
- Sponsor
- Pfizer
MASH, NASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression…
- Conditions
- MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis
- Trial name
- FASCINATE-3 (NCT06594523)
- Testing
- Denifanstat
- Sponsor
- Sagimet Biosciences Inc.
Non-Alcoholic Steatohepatitis (NASH)
Tolerability, Efficacy, and PK of ZSP1601 in Patients With Non-Alcoholic Steatohepatitis (NASH)
Double-blind, randomized, placebo-controlled study to explore the safety, tolerability PK characteristics and early efficacy of ZSP1601 tablets in patients with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT04140123
- Testing
- ZSP1601
- Where
- China
- Volunteers
- 37 people
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
Nonalcoholic Steatohepatitis
Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of study drug(s) in participants with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT03987074
- Testing
- Semaglutide, Firsocostat, Cilofexor
- Where
- 18 sites in United States
- Volunteers
- 109 people
- Sponsor
- Gilead Sciences
Nonalcoholic Steatohepatitis (NASH)
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NASH (NCT04134091)
- Testing
- LPCN 1144 Formulation A, LPCN 1144 Formulation B
- Where
- 19 sites in United States
- Volunteers
- 56 people
- Sponsor
- Lipocine Inc.
NASH - Nonalcoholic Steatohepatitis
Absorption, Metabolism and Excretion (AME) Study of [14C]EDP-305 in Healthy Male Subjects
A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
- Trial name
- NCT03748628
- Testing
- EDP-305
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Nonalcoholic Steatohepatitis (NASH)
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
- Trial name
- NCT02443116
- Testing
- NGM282
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 254 people
- Sponsor
- NGM Biopharmaceuticals, Inc
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver Disease, Nonalcoholic
Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
The goal of this clinical trial is to evaluate whether a specific probiotic mixture can improve liver health in adults with moderate metabolic dysfunction-associated steatotic liver disease (MASLD).
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver Disease, Nonalcoholic, Overweight (BMI > 25)
- Trial name
- NCT07193927
- Testing
- Lactiplantibacillus plantarum Probiotic Mixture
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- AB Biotics, SA
Non-alcoholic Fatty Liver Disease
Hepar-P Study to Evaluate the Safety and Efficacy of a Standardised Extract of Phyllanthus Niruri for the Treatment of Non-alcoholic Fatty Liver Disease
This is a multi-center, double blind, parallel group placebo controlled randomised trial designed to determine the safety and efficacy of a Standardised Extract of Phyllanthus Niruri (EPN 797) HEPAR-P capsule for the treatment of…
- Trial name
- Hepar-P (NCT01680003)
- Testing
- Hepar-P
- Where
- 5 sites in Malaysia
- Volunteers
- 50 people
- Sponsor
- Nova Laboratories Sdn Bhd
Liver Fibrosis Due to NASH
Safety and Efficacy of Simtuzumab (SIM, GS-6624) in Adults With Advanced Liver Fibrosis But Not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether SIM (formerly referred to as GS-6624) is effective at preventing the histologic progression of liver fibrosis and the clinical progression to cirrhosis in participants…
- Trial name
- NCT01672866
- Testing
- SIM
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 222 people
- Sponsor
- Gilead Sciences
Cirrhosis, Portal Hypertension
Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG ≥12 mmHg as determined by the central reader assigned to this…
- Conditions
- Cirrhosis, Portal Hypertension, Non-alcoholic Steatohepatitis
- Trial name
- ENCORE-PH (NCT02960204)
- Testing
- Emricasan
- Where
- 37 sites in United States, Germany and 1 more
- Volunteers
- 263 people
- Sponsor
- Histogen
Non Alcoholic Steatohepatitis (NASH)
Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment
The primary objectives of this study are to evaluate the effect of Obeticholic Acid treatment compared to placebo on 1) histological improvement and 2) liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic…
- Trial name
- REGENERATE (NCT02548351)
- Testing
- Obeticholic Acid
- Where
- 346 sites in United States, Australia and 19 more
- Volunteers
- 2,477 people
- Sponsor
- Intercept Pharmaceuticals
Non-alcoholic Steatohepatitis (NASH)
A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male Subjects
This is a first-in-human (FIH) study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of AZD4076 tetracosasodium in healthy male subjects at increasing single doses
- Trial name
- NCT02612662
- Testing
- AZD4076
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- AstraZeneca
Non-alcoholic Steatohepatitis (NASH)
Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis
The purpose of this study was to assess the safety, tolerability, and efficacy of a combination treatment of tropifexor (LJN452) and cenicriviroc (CVC) in adult patients with nonalcoholic steatohepatitis (NASH) and liver fibrosis.
- Trial name
- TANDEM (NCT03517540)
- Testing
- Tropifexor (LJN452), Cenicriviroc (CVC)
- Where
- 65 sites in United States, Argentina and 15 more
- Volunteers
- 193 people
- Sponsor
- Novartis Pharmaceuticals
Healthy
Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06835919 in healthy adult Japanese participants.
- Trial name
- NCT04427917
- Testing
- PF-06835919
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Plaque Psoriasis, Non-alcoholic Fatty Liver Disease
A Study of Secukinumab Treatment in Patients With Plaque Psoriasis and Coexisting Non-alcoholic Fatty Liver Disease (NAFLD)
The aim of this study was to assess the therapeutic efficacy of secukinumab on the psoriatic skin and to explore the anti-inflammatory (reduction of hepatic inflammation and cell damage), anti-steatotic (reduction of hepatic…
- Trial name
- pINPOINt (NCT04237116)
- Testing
- Investigational Arm - secukinumab
- Where
- 8 sites in Germany, Spain
- Volunteers
- 10 people
- Sponsor
- Novartis Pharmaceuticals
Nonalcoholic Steatohepatitis (NASH)
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis
This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT04521114)
- Testing
- leronlimab 700 mg, leronlimab 350 mg
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- CytoDyn, Inc.