Clinical trials: NAFLD
NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Safety, Efficacy and Tolerability of BIO89-100 in Subjects With Biopsy-confirmed Nonalcoholic Steatohepatitis (NASH)
This is a randomized, double-blind, placebo-controlled study that will evaluate the safety, efficacy, tolerability of BIO89-100 in patients with biopsy-confirmed fibrosis stages F2-F3 NASH.
- Trial name
- ENLIVEN (NCT04929483)
- Testing
- BIO89-100
- Where
- 89 sites in United States, Puerto Rico
- Volunteers
- 222 people
- Sponsor
- 89bio, Inc.
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
Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to determine if the investigational treatment volixibat (SHP626) is safe, tolerable and effective in adults with nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT02787304
- Testing
- SHP626
- Where
- 65 sites in United States, Canada and 2 more
- Volunteers
- 197 people
- Sponsor
- Mirum 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.
Nonalcoholic Steatohepatitis
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
- Trial name
- STELLAR-4 (NCT03053063)
- Testing
- SEL
- Where
- 283 sites in United States, Australia and 20 more
- Volunteers
- 883 people
- Sponsor
- Gilead Sciences
Nonalcoholic Steatohepatitis
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).
- Trial name
- SYNERGY-NASH (NCT04166773)
- Testing
- Tirzepatide
- Where
- 112 sites in United States, Belgium and 8 more
- Volunteers
- 190 people
- Sponsor
- Eli Lilly and Company
Non-Alcoholic Steatohepatitis
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
- Trial name
- NCT02287779
- Testing
- SHP626
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Mirum Pharmaceuticals, Inc.
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
Non-alcoholic Steatohepatitis
Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to assess the effects of EYP001a (Vonafexor) with respect to safety, tolerability, pharmacokinetics and on markers of liver inflammation in patients with NASH
- Trial name
- NCT03812029
- Testing
- Vonafexor
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 120 people
- Sponsor
- Enyo Pharma
Steatohepatitis
Double-Blind, Placebo-Controlled Study of Two Doses of EPA-E in Patients With Non Alcoholic Steatohepatitis (NASH)
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT01154985
- Testing
- EPA-E 300 mg capsule
- Where
- 34 sites in United States, Puerto Rico
- Volunteers
- 243 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Nonalcoholic Steatohepatitis
Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL)
This Phase 2, double-blind, randomized, placebo-controlled, multicenter study, with an open-label long-term safety extension (LTSE), will evaluate the effect of Obeticholic Acid, and the subsequent addition of statin therapy, on…
- Trial name
- CONTROL (NCT02633956)
- Testing
- Obeticholic Acid, Atorvastatin
- Where
- 22 sites in United States
- Volunteers
- 84 people
- Sponsor
- Intercept Pharmaceuticals
Non-Alcoholic Steatohepatitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
- Trial name
- NCT03421431
- Testing
- EDP-305 Dose 1, EDP-305 Dose 2
- Where
- 82 sites in United States, Canada and 4 more
- Volunteers
- 134 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Non-alcoholic Steatohepatitis, Hypertriglyceridemia
Open-Label Study To Evaluate MN-001 on HDL & Triglyceride in NASH & NAFLD Subjects
This is a multi-center, proof-of-principle, open-label study designed to evaluate the efficacy, safety, and tolerability of MN-001 in non-alcoholic steatohepatitis (NASH) and Non-Alcoholic Fatty Liver Disease (NAFLD) subjects…
- Conditions
- Non-alcoholic Steatohepatitis, Hypertriglyceridemia, Non-alcoholic Fatty Liver Disease, Hypercholesterolemia
- Trial name
- NCT02681055
- Testing
- MN-001
- Where
- 3 sites in United States
- Volunteers
- 19 people
- Sponsor
- MediciNova
Prediabetic State, Non-alcoholic Fatty Liver Disease
ORION: Effects of Cenicriviroc on Insulin Sensitivity in Subjects With Prediabetes or Type 2 Diabetes Mellitus (T2DM) and Suspected NAFLD
A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study of cenicriviroc (CVC) to be conducted in approximately 50 adult obese subjects [body mass index (BMI) ≥ 30 kg/m^2] with prediabetes or type 2 diabetes…
- Conditions
- Prediabetic State, Non-alcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus
- Trial name
- NCT02330549
- Testing
- Cenicriviroc 150 mg
- Where
- 3 sites in United States, Puerto Rico
- Volunteers
- 45 people
- Sponsor
- Tobira Therapeutics, Inc.
Non-Alcoholic Steatohepatitis
BREATHID Octanoate Breath Test With or Without Methacetin Breath Test for Correlation With Biopsy in NASH
This study's aim is to develop an algorithm for the ¹³C-Octanoate Breath Test with or without the ¹³C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings associated with of Non-Alcoholic…
- Trial name
- NCT02314026
- Testing
- Suspected NASH BreathID test with 13C-Octanoate, Suspected NASH Breath test with 13C Methacetin
- Where
- 11 sites in United States, Belgium and 2 more
- Volunteers
- 140 people
- Sponsor
- Meridian Bioscience, Inc.
Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis
A Study to Evaluate the Safety, Tolerability & Efficacy of MSDC-0602K in Patients With NASH
This is a randomized, double-blinded study of three doses of MSDC-0602K or placebo given orally once daily to subjects with biopsy proven NASH with fibrosis and no cirrhosis.
- Conditions
- Non-alcoholic Fatty Liver Disease, Non-alcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis
- Trial name
- EMMINENCE (NCT02784444)
- Testing
- MSDC-0602K
- Where
- 43 sites in United States
- Volunteers
- 392 people
- Sponsor
- Cirius Therapeutics, Inc.
Nonalcoholic Steatohepatitis (NASH)
Safety and Effectiveness of BMS-986263 in Adults With Compensated Cirrhosis (Liver Disease) From Nonalcoholic Steatohepatitis (NASH)
The purpose of this randomized study is to assess safety and effectiveness of BMS-986263 in adults with compensated cirrhosis (chronic liver disease) from nonalcoholic steatohepatitis (fatty liver disease) (NASH).
- Trial name
- NCT04267393
- Testing
- BMS-986263
- Where
- 112 sites in United States, Argentina and 14 more
- Volunteers
- 124 people
- Sponsor
- Bristol-Myers Squibb
Non Alcoholic Steatohepatitis (NASH)
A Phase 2b Study of Icosabutate in Fatty Liver Disease
A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of NASH without worsening of fibrosis
- Trial name
- ICONA (NCT04052516)
- Testing
- Icosabutate
- Where
- 39 sites in United States, Puerto Rico
- Volunteers
- 280 people
- Sponsor
- NorthSea Therapeutics B.V.
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients…
- Conditions
- Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NAVIGATE (NCT04365868)
- Testing
- belapectin
- Where
- 156 sites in United States, Argentina and 13 more
- Volunteers
- 357 people
- Sponsor
- Galectin Therapeutics Inc.
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.