Clinical trials: NASH - Nonalcoholic Steatohepatitis
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.
NASH - Nonalcoholic Steatohepatitis
Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
- Trial name
- HM-TRIA-201 (NCT04505436)
- Testing
- HM15211
- Where
- 60 sites in United States, South Korea
- Volunteers
- 215 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
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.
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver
Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis
This study is a Phase 1, first-in-human single-dose escalation and multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.
- Trial name
- NCT05680233
- Testing
- OA-235i (4 mg), OA-235i (8 mg), OA-235i (16 mg)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Oasis Pharmaceuticals, LLC
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 Fatty Liver
A Study to Assess the Pharmacokinetics of PXL770 After 4 Weeks of Treatment in Subjects With NAFLD
This study will assess the pharmacokinetics of PXL770 after 4 weeks of treatment.
- Trial name
- NCT03950882
- Testing
- PXL770
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Poxel SA
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.
Nonalcoholic Steatohepatitis (NASH)
A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension
This is a randomized, blinded, placebo-controlled study of Efimosfermin in obese participants at risk for, or with biopsy-confirmed, nonalcoholic steatohepatitis (NASH), with a single arm open-label extension.
- Trial name
- NCT04880031
- Testing
- Efimosfermin
- Where
- 48 sites in United States
- Volunteers
- 231 people
- Sponsor
- GlaxoSmithKline
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
Hepatic Cirrhosis, Nonalcoholic Steatohepatitis
Clearance of NRL972 in Patients With Cirrhosis, Nonalcoholic Steatohepatitis (NASH) and in Healthy Volunteers
The study was conducted to describe and compare the plasma pharmacokinetics of NRL972 administered after a standard meal and while fasted in patients with hepatic cirrhosis (Child-Turcotte-Pugh [CTP] class A-C), NASH, young and…
- Trial name
- NCT00856869
- Testing
- NRL972
- Where
- Bulgaria
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- Norgine
Healthy
Study to Estimate How Common it is to Have Genetic Variants Associated With NAFLD
The purpose of this study is to estimate the prevalence of genetic variants associated with liver disease in participants who are known, or are likely to have NAFLD.
- Trial name
- NCT04494360
- Testing
- No intervention
- Where
- 3 sites in United States
- Volunteers
- 830 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Nonalcoholic Steatohepatitis (NASH)
Study in Chinese Healthy Adults to Evaluate the Safety, Tolerability and Pharmacokinetics on ZSP1601, and the Effect of Food on ZSP1601 Pharmacokinetics
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of ZSP1601 on fasted condition, and characterize PK of ZSP1601 on an empty stomach (fasted condition) and…
- Trial name
- NCT03392779
- Testing
- ZSP1601 25 mg, ZSP1601 50 mg, ZSP1601 100 mg
- Where
- China
- Volunteers
- 94 people, healthy volunteers welcome
- Sponsor
- Guangdong Zhongsheng Pharmaceutical Co., Ltd.
Non-Alcoholic Fatty Liver
Study to Evaluate the Effect of Elafibranor on Hepatic Lipid Composition in Subjects With Nonalcoholic Fatty Liver (NAFL)
This randomized, double-blind, cross-over (placebo or elafibranor [GFT505]) placebo-controlled study, will evaluate the effect on hepatic lipid composition and safety of elafibranor 120 mg quaque die (QD) versus placebo in an…
- Trial name
- NCT03953456
- Testing
- elafibranor 120mg
- Where
- Netherlands
- Volunteers
- 17 people
- Sponsor
- Genfit
Obesity, Nonalcoholic Steatohepatitis
ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
This study was a FIH, Phase 1, randomized, double-blind, placebo-controlled, 2-part single-ascending dose (SAD) and multiple-ascending dose (MAD) study of ALT-801 (pemvidutide) in healthy overweight and obese subjects.
- Trial name
- NCT04561245
- Testing
- ALT-801
- Where
- Australia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Altimmune, 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
Morbid Obesity, Metabolic Disease
Study Evaluating Metabolic Syndrome in Subjects Undergoing Gastric Bypass Bariatric Syndrome
Metabolic syndrome is rapidly emerging as an epidemic of global proportions and its definition is still evolving. Patients with this syndrome are at increased risk for cardiovascular disease, and at increased risk of mortality…
- Trial name
- NCT00283374
- Testing
- Laparoscopic Roux-en-Y Gastric Bypass
- Where
- 17 sites in United States, Italy and 1 more
- Volunteers
- 120 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
NASH - Nonalcoholic Steatohepatitis, Healthy
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients
This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X…
- Trial name
- NCT03976687
- Testing
- EYP001a
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Enyo Pharma
NASH - Nonalcoholic Steatohepatitis
Namodenoson in the Treatment of Non-Alcoholic Steatohepatitis (NASH)
Subjects with biopsy-proven NASH will be randomly assigned in a 2:1 ratio to oral doses of namodenoson 25 mg every 12 hours or matching placebo every 12 hours for 36 weeks.
- Trial name
- NCT04697810
- Testing
- Namodenoson
- Where
- 24 sites in Bosnia and Herzegovina, Bulgaria and 4 more
- Volunteers
- 114 people
- Sponsor
- Can-Fite BioPharma