Clinical trials: NASH (Non-Alcoholic Steatohepatitis)
NASH - Nonalcoholic Steatohepatitis
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
- Trial name
- NCT04685993
- Testing
- LPCN 1144
- Where
- 10 sites in United States
- Volunteers
- 25 people
- Sponsor
- Lipocine Inc.
NASH - Nonalcoholic Steatohepatitis
AVIATION Study: A Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TERN-201 in Patients With Non-Cirrhotic Non-Alcoholic Steatohepatitis
This is a Phase 1b multi-center, randomized, double-blind, dose-ranging, placebo-controlled, adaptive study to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD) of TERN-201 in patients with non-cirrhotic NASH.
- Trial name
- NCT04897594
- Testing
- TERN-201
- Where
- 11 sites in United States
- Volunteers
- 52 people
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Nonalcoholic Steatohepatitis (NASH)
A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)
A Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)
- Trial name
- NCT04616014
- Testing
- ORMD-0801 QD
- Where
- Belgium
- Volunteers
- 7 people
- Sponsor
- Oramed, Ltd.
Non-Alcoholic Steatohepatitis (NASH), Type2 Diabetes Mellitus
A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)
This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes.
- Trial name
- NCT02653300
- Testing
- Oral Insulin
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Oramed, Ltd.
Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH)
Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD)
Does the novel drug decrease liver fat in subjects with NASH or NAFLD as compared to placebo
- Trial name
- NCT02605616
- Testing
- AZ compound
- Where
- United States
- Volunteers
- 93 people
- Sponsor
- University of Alabama at Birmingham
NASH - Nonalcoholic Steatohepatitis
Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects…
- Trial name
- NCT04874233
- Testing
- HU6
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Rivus Pharmaceuticals, Inc.
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
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in NASH patients after 36 weeks of treatment
- Trial name
- NCT04321343
- Testing
- PXL065
- Where
- 29 sites in United States
- Volunteers
- 117 people
- Sponsor
- Poxel SA
NAFLD, NASH - Nonalcoholic Steatohepatitis
Quantitative Ultrasound With Liver Incytes for Evaluation of Non-Alcoholic Fatty Liver Disease
The purpose of this study is to prospectively evaluate the utility of Liver Incytes in assessing NAFLD with or without advanced fibrosis in patients seen in liver clinics for suspected NAFLD diagnosis.
- Trial name
- NCT04576923
- Testing
- Velacur by Sonic Incytes
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- Indiana University
NAFLD, NASH - Nonalcoholic Steatohepatitis
Vitamin E for NASH Treatment in HIV Infected Individuals
The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition…
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, HIV Infections
- Trial name
- NCT03669133
- Testing
- Vitamin E
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Indiana University
Non-Alcoholic Steatohepatitis (NASH)
Phase 2b Study in NASH to Assess IVA337
Non-alcoholic steatohepatitis, abbreviated as NASH, is a chronic liver disease that may progress to cirrhosis. The disease is mostly associated with obesity and type 2 diabetes mellitus, or insulin resistance and is very common.
- Trial name
- NATIVE (NCT03008070)
- Testing
- IVA337
- Where
- 85 sites in United States, Australia and 14 more
- Volunteers
- 247 people
- Sponsor
- Inventiva Pharma
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.
Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
A Phase 2 study with 4 treatment groups of two differing doses and matched placebos designed to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of MEDI0382 in obese…
- Trial name
- NCT04019561
- Testing
- MEDI0382 high dose, MEDI0382 low dose
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 74 people
- Sponsor
- MedImmune LLC
NASH - Nonalcoholic Steatohepatitis, Cirrhosis
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-14
To validate the ability of the Methacetin Breath Test (MBT) to detect clinically significant portal hypertension (CSPH)/severe portal hypertension (SPH) defined as hepatic venous pressure gradient (HVPG) ≥ 10 mmHg and HVPG ≥ 12…
- Conditions
- NASH - Nonalcoholic Steatohepatitis, Cirrhosis, Portal Hypertension
- Trial name
- NCT03439189
- Testing
- Methacetin Breath Test, Emricasan
- Where
- France
- Volunteers
- 343 people
- Sponsor
- Meridian Bioscience, Inc.
NASH - Nonalcoholic Steatohepatitis
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.
- Trial name
- NCT03611101
- Testing
- ¹³C-Methacetin Breath Test, BMS-986036, BreathID MCS device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Meridian Bioscience, Inc.
Non-Alcoholic Steatohepatitis (NASH)
Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH)
Abdominal obesity and type-2 Diabetes are associated with chronic liver disorders resulting from the accumulation of fat in the liver (steatosis), which may progress towards hepatitis and possibly lead to cirrhosis and liver…
- Trial name
- NCT01694849
- Testing
- GFT505 80mg, GFT505 120mg
- Where
- 56 sites in United States, Belgium and 7 more
- Volunteers
- 275 people
- Sponsor
- Genfit
NASH - Nonalcoholic Steatohepatitis
A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)
A Phase 2, Double-Blind (DB), Randomized, Placebo-Controlled Study Followed by an Open-Label Extension Period to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH) OLE phase was not analyzed…
- Trial name
- NCT03551522
- Testing
- Seladelpar
- Where
- 14 sites in United States
- Volunteers
- 181 people
- Sponsor
- Gilead Sciences
Nonalcoholic Steatohepatitis (NASH)
Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH)
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NCT03823703
- Testing
- Miricorilant
- Where
- 15 sites in United States
- Volunteers
- 12 people
- Sponsor
- Corcept Therapeutics
NASH - Nonalcoholic Steatohepatitis
LIFT Study: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of TERN-101 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis (NASH)
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics (PK) of TERN-101 in non-cirrhotic NASH patients.
- Trial name
- NCT04328077
- Testing
- TERN-101
- Where
- 31 sites in United States
- Volunteers
- 101 people
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study administered for 16 weeks in subjects with biopsy proven F1 - F4 NASH.
- Trial name
- NCT03976401
- Testing
- EFX
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 110 people
- Sponsor
- Akero Therapeutics, Inc