Clinical trials: Non Alcoholic Steatohepatitis (NASH)
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.
- Trial name
- LEGEND (NCT05232071)
- Testing
- Lanifibranor, Empagliflozin
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Inventiva Pharma
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
- Trial name
- NCT05039450
- Testing
- EFX
- Where
- 49 sites in United States, Mexico and 1 more
- Volunteers
- 213 people
- Sponsor
- Akero Therapeutics, Inc
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 - Nonalcoholic Steatohepatitis
Phase 2a Study of HPG1860 in Subjects With NASH
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel group, multiple arm, multicenter study of 3 different doses of HPG1860 versus placebo in subjects with biopsy-confirmed or phenotypic NASH.
- Trial name
- RISE (NCT05338034)
- Testing
- HPG1860
- Where
- United States
- Volunteers
- 89 people
- Sponsor
- Hepagene (Shanghai) Co., Ltd.
Nonalcoholic Steatohepatitis (NASH)
A Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects With NASH (ARMOR)
An Open-Label Part was added: This part will enroll in selected sites which are less affected by the COVID-19 pandemic. 150 subjects with NASH and fibrosis confirmed by liver histology (F1-F3) will be randomized into 3 groups…
- Trial name
- ARMOR (NCT04104321)
- Testing
- Aramchol free acid
- Where
- 2 sites in United States
- Volunteers
- 157 people
- Sponsor
- Galmed Research and Development, Ltd.
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.
NAFLD, Nonalcoholic Fatty Liver
The Impact of Ibutamoren on Nonalcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United…
- Conditions
- NAFLD, Nonalcoholic Fatty Liver, NASH - Nonalcoholic Steatohepatitis
- Trial name
- NCT05364684
- Testing
- LUM-201
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Nonalcoholic Steatohepatitis (NASH), Overweight or Obesity
A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis
This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts.
- Trial name
- NCT04004325
- Testing
- FT-4101, Deuterated Water
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Forma Therapeutics, 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
NASH - Nonalcoholic Steatohepatitis
Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.
- Trial name
- NCT03912532
- Testing
- NGM282
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 171 people
- Sponsor
- NGM Biopharmaceuticals, Inc
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
- Trial name
- Harmony (NCT04767529)
- Testing
- Efruxifermin
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 128 people
- Sponsor
- Akero Therapeutics, Inc
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
NASH - Nonalcoholic Steatohepatitis
Spironolactone Therapy In Young Women With NASH
Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years.
- Trial name
- NCT03576755
- Testing
- Spironolactone 100mg
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Francisco
NASH - Nonalcoholic Steatohepatitis
DUET Study: A Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy and in Combination With TERN-101 in Noncirrhotic Adults With Presumed Non-Alcoholic Steatohepatitis
This is a Phase 2a Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Orally Administered TERN-501 as Monotherapy as well as in…
- Trial name
- NCT05415722
- Testing
- TERN-501, TERN-101
- Where
- 35 sites in United States
- Volunteers
- 162 people
- Sponsor
- Terns, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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.
Non Alcoholic Steatohepatitis (NASH)
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult…
- Trial name
- ELIVATE (NCT04065841)
- Testing
- Tropifexor, Licogliflozin
- Where
- 80 sites in United States, Argentina and 22 more
- Volunteers
- 234 people
- Sponsor
- Novartis Pharmaceuticals
Non-alcoholic Steatohepatitis (NASH)
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
This study is open for men and women with a liver disease called nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose of the study is to find out whether a medicine called BI 456906 helps patients with NASH and…
- Trial name
- NCT04771273
- Testing
- Survodutide
- Where
- 154 sites in United States, Australia and 23 more
- Volunteers
- 295 people
- Sponsor
- Boehringer Ingelheim
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
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
Diabetes Mellitus, Type 2, NASH - Nonalcoholic Steatohepatitis
A Study to Assess the Safety and Efficacy of Oral Insulin in T2DM Patients With Nonalcoholic Steatohepatitis (NASH)
This is a double-blind, randomized, placebo-controlled, multi-center study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM.
- Trial name
- NCT04618744
- Testing
- ORMD-0801 (Insulin) capsule 8 mg BD
- Where
- 3 sites in United States, Israel
- Volunteers
- 32 people
- Sponsor
- Oramed, Ltd.