Clinical trials: Steatohepatitis, Nonalcoholic
Metabolic Dysfunction-assocated Steatohepatitis/ Nonalcoholic Fatty Liver Disease
Study of TVB-2640 in Subjects With Nonalcoholic Steatohepatitis (NASH)
This is a Phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy on TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH).
- Trial name
- NCT04906421
- Testing
- TVB-2640
- Where
- 117 sites in United States, Canada and 2 more
- Volunteers
- 168 people
- Sponsor
- Sagimet Biosciences Inc.
Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 in subjects with nonalcoholic steatohepatitis (NASH).
- Conditions
- Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Fatty Liver
- Trial name
- NCT05979779
- Testing
- HU6
- Where
- 20 sites in United States
- Volunteers
- 219 people
- Sponsor
- Rivus Pharmaceuticals, Inc.
NAFLD, NASH
LITMUS Imaging Study
The LITMUS Imaging Study is a prospectively recruited, observational study of patients with histologically characterised non-alcoholic fatty liver disease (NAFLD).
- Conditions
- NAFLD, NASH, NASH - Nonalcoholic Steatohepatitis, Fibrosis, Liver
- Trial name
- NCT05479721
- Where
- 18 sites in United States, Finland and 8 more
- Volunteers
- 450 people
- Sponsor
- University of Oxford
Nonalcoholic Steatohepatitis (NASH)
To Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effects of IMM-H014 in Healthy Subjects
This study will evaluate the safety, tolerability and pharmacokinetics (PK) of escalating single- and multiple-oral doses of IMM-H014 on fasted condition, and characterize PK of IMM-H014 on an empty stomach (fasted condition) and…
- Trial name
- NCT06216041
- Testing
- IMM-H014, IMM-H014 ( FE)
- Where
- China
- Volunteers
- 138 people, healthy volunteers welcome
- Sponsor
- Changchun Intellicrown Pharmaceutical Co. LTD
Type 2 Diabetes Mellitus (T2DM), Nonalcoholic Steatohepatitis
Low-Dose Pioglitazone in Patients With NASH (AIM 2)
To determine the safety and efficacy of low-dose pioglitazone (15 mg per day) on liver histology in in patients with T2DM with biopsy-proven nonalcoholic steatohepatitis (NASH).
- Trial name
- NCT04501406
- Testing
- Pioglitazone
- Where
- United States
- Volunteers
- 166 people
- Sponsor
- University of Florida
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
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.
- Trial name
- NCT04210245
- Testing
- aldafermin
- Where
- 49 sites in United States, Australia and 7 more
- Volunteers
- 160 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis With Liver Fibrosis
Metabolic Interventions to Resolve Non-alcoholic Steatohepatitis (NASH) With Fibrosis (MIRNA)
The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor).
- Trial name
- MIRNA (NCT04321031)
- Testing
- PF-06865571, PF-05221304
- Where
- 291 sites in United States, Bulgaria and 10 more
- Volunteers
- 256 people
- Sponsor
- Pfizer
Nonalcoholic Steatohepatitis (NASH)
A Randomized, Double-blind, Placebo-controlled Study of ZSP1601 in Adult Subjects With Nonalcoholic Steatohepatitis (NASH)
The purpose of this research is to evaluate the efficacy and the safety of two doses of ZSP1601 for 48 weeks versus placebo in adult NASH patients.
- Trial name
- NCT05692492
- Testing
- ZSP1601
- Where
- China
- Volunteers
- 180 people
- Sponsor
- Guangdong Raynovent Biotech Co., Ltd
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)
NASH, MASH
ALG-055009 in Non-cirrhotic Adults With MASH (HERALD)
This is a Phase 2a study to evaluate the safety, tolerability, efficacy, pharmacokinetics, and pharmacodynamics of oral (PO) daily (QD) doses of ALG-055009 (soft gelatin [softgel] capsule) for 12 weeks.
- Conditions
- NASH, MASH, Metabolic Dysfunction-Associated Steatohepatitis, Nonalcoholic Steatohepatitis
- Trial name
- HERALD (NCT06342947)
- Testing
- ALG-055009
- Where
- 40 sites in United States
- Volunteers
- 102 people
- Sponsor
- Aligos Therapeutics
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
Nonalcoholic Steatohepatitis, NASH - Nonalcoholic Steatohepatitis
Safety Evaluation of IV Tc 99m Tilmanocept and Comparison of Imaging With Sulfur Colloid in Subjects With and Without NASH
This is a prospective, open-label, multicenter, safety, comparative study of IV administered Tc99m-tilmanocept and unfiltered Tc99m sulfur colloid in the detection of and assessment of three dimensional tessellation localization…
- Trial name
- NCT03332940
- Testing
- Tc 99M Sulfur Colloid, Tc99m-tilmanocept
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Navidea Biopharmaceuticals
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
The Liver Health Study for Patients with NAFLD
The study will investigate whether the level of fat stored in the liver is related to the liver's ability to burn fat.
- Conditions
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Obesity
- Trial name
- NCT03151798
- Testing
- Phase II: Lifestyle treatment, Phase II: Control treatment, Phase I: Observational studies
- Where
- United States
- Volunteers
- 336 people
- Sponsor
- University of Missouri-Columbia
Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
De Novo Lipogenesis in Severity of NAFLD
NAFLD is the most prevalent liver disease in the U.S., and there is a serious need to understand its progression to the advanced state, nonalcoholic steatohepatitis (NASH).
- Conditions
- Nonalcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis, Bariatric Surgery Candidate, Obesity, Morbid
- Trial name
- NCT03683589
- Where
- United States
- Volunteers
- 49 people
- Sponsor
- University of Missouri-Columbia
Diabetes Mellitus, Type 2, PreDiabetes
Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
This 12-week controlled diet and weight intervention study seeks to define the molecular pathways that link excess body weight to the development of insulin resistance (IR).
- Conditions
- Diabetes Mellitus, Type 2, PreDiabetes, Insulin Resistance, Obesity
- Trial name
- NCT05165706
- Testing
- Dietary Intervention Mediterranean Low Carbohydrate Diet, Dietary Intervention Standard Low Carbohydrate Diet, Dietary Intervention Standard Low Fat Diet
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- Stanford University
Steatohepatitis, Nonalcoholic
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Multiple Doses of ION224
The purpose of this study is to assess the effect of multiple ION224 doses when administered by subcutaneous (SC) injection for 49 weeks (end of the treatment [EOT]) on non-alcoholic steatohepatitis (NASH) histologic improvement…
- Trial name
- NCT04932512
- Testing
- ION224
- Where
- 51 sites in United States, Puerto Rico
- Volunteers
- 160 people
- Sponsor
- Ionis Pharmaceuticals, Inc.
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Comparative and Additive Diagnostic Performance of Magnetic Resonance Elastography (MRE) and Corrected-T1 (cT1) for Fibrosis and Inflammation in Nonalcoholic Steatohepatitis (NASH) Using Histology As Reference
This pilot study will evaluate conventional and investigational MR imaging and spectroscopic sequences and collect data to help plan more definitive future studies.
- Conditions
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Liver Fibroses, Liver Inflammation
- Trial name
- NCT04389593
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of California, San Diego
Non-Alcoholic Fatty Liver Disease, Nonalcoholic Steatohepatitis
Saroglitazar Magnesium in Patients With Nonalcoholic Fatty Liver Disease and/or Nonalcoholic Steatohepatitis
This is a randomized, double-blind, placebo-controlled study in up to 104 patients with a diagnosis of Non-alcoholic fatty Liver disease (NAFLD) and/or Non-alcoholic steatohepatitis (NASH).
- Trial name
- EVIDENCES IV (NCT03061721)
- Testing
- Saroglitazar magnesium 1 mg, Saroglitazar magnesium 2 mg, Saroglitazar magnesium 4 mg
- Where
- 18 sites in United States
- Volunteers
- 106 people
- Sponsor
- Zydus Therapeutics Inc.
Nonalcoholic Steatohepatitis
Dose Escalation Study of Kylo-0603 in Healthy Subjects
This clinical trial is the first-in-human study of Kylo-0603. The purpose of this randomized, double-blind, placebo-controlled phase 1 study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and effect of…
- Trial name
- NCT06365580
- Testing
- Kylo-0603 capsule
- Where
- China
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- Kylonova (Xiamen) Biopharma co., LTD.