Clinical trials: Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Condition Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Funder type Industry (pharma, biotech, devices)
Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM)
Phase 1 Clinical Study of MWN105 Injection in Participants With Overweight or Obesity
This study is a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation phase I clinical trial aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN105…
- Conditions
- Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Trial name
- NCT07803809
- Testing
- MWN105 1, MWN105 2, MWN105 3
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Shanghai Minwei Biotechnology Co., Ltd
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.
MASH, NASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression…
- Conditions
- MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis
- Trial name
- FASCINATE-3 (NCT06594523)
- Testing
- Denifanstat
- Sponsor
- Sagimet Biosciences Inc.
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
- Trial name
- NCT06108219
- Testing
- Miricorilant (Cohort A), Miricorilant (Cohort B)
- Where
- 77 sites in United States, India and 1 more
- Volunteers
- 175 people
- Sponsor
- Corcept Therapeutics
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Rezdiffra® With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and F2-F3 Fibrosis
To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin \& Actos/pioglitazone)
- Trial name
- NCT07848191
- Testing
- Rezdiffra, Resmetirom, ACTOS/pioglitazone
- Where
- 16 sites in United States
- Volunteers
- 150 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called MASH. In this study, researchers are looking at the effect of ALN-CIDEB on reducing liver fat, liver…
- Trial name
- NCT07631637
- Testing
- ALN-CIDEB
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Regeneron Pharmaceuticals
MASLD
Phase II Study Evaluating the Efficacy and Safety of DR10624 Injection in MASLD and MetALD Subjects
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase II clinical trial that consists of two parts.
- Trial name
- NCT07024212
- Testing
- DR10624 Injection
- Where
- 4 sites in China, Hong Kong
- Volunteers
- 110 people
- Sponsor
- Zhejiang Doer Biologics Co., Ltd.
MASH, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Study of Resmetirom in Children and Adolescents With MASH
This study will evaluate the safety, pharmacokinetics (how the body absorbs, distributes, metabolizes, and eliminates the drug), and pharmacodynamics (how the drug affects the body) of resmetirom in children and adolescents with…
- Trial name
- NCT07763015
- Testing
- Resmetirom
- Where
- United States
- Volunteers
- 61 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis
The purpose of this study is to investigate the efficacy and safety of HRS-4729 injection and HRS9531 injection in adult participants with metabolic dysfunction-associated steatohepatitis after 52 weeks of treatment.
- Trial name
- NCT07660848
- Testing
- HRS-4729 Injection, HRS9531 Injection
- Where
- 2 sites in China
- Volunteers
- 160 people
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
AGED Diagnostics Clinical Validation Study
Validation of Blood-Based Tests for the Diagnosis of Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Liver Fibrosis: This study aims to validate two investigational blood tests developed by AGED Diagnostics for the…
- Conditions
- MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease), Fibrosis and Cirrhosis of Liver, MetALD
- Trial name
- NCT07867574
- Where
- United States
- Volunteers
- 500 people
- Sponsor
- Active Genomes Expressed Diagnostics, Corp
Non-alcoholic Fatty Liver Disease
A Clinical Study to Investigate the Safety and Tolerability of Efimosfermin Alfa Injection in Participants With Known or Suspected F2- or F3-stage MASH
This study will evaluate the safety and tolerability of Efimosfermin Alfa for participants with known or suspected MASH with fibrosis consistent with stage F2 or F3.
- Trial name
- ZENITH-2 (NCT07221188)
- Testing
- Efimosfermin Alfa
- Where
- 66 sites in United States, Australia and 6 more
- Volunteers
- 1,250 people
- Sponsor
- GlaxoSmithKline
Metabolic Dysfunction-Associated SteatoHepatitis (MASH)
A Precision Medicine Approach Using Gene Silencing to Treat a Chronic Liver Disease Called Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Adult Participants at Increased Genetic Risk for This Condition
This study is researching an investigational drug, ALN-HSD called "study drug". This study is focused on participants who are known to have Metabolic dysfunction-Associated SteatoHepatitis (MASH).
- Trial name
- NASHGEN-2 (NCT05519475)
- Testing
- ALN-HSD
- Where
- 71 sites in United States, Japan and 2 more
- Volunteers
- 120 people
- Sponsor
- Regeneron Pharmaceuticals
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Evaluating the Pharmacokinetics and Safety of Miricorilant
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT07553663
- Testing
- Miricorilant
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Corcept Therapeutics
NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
- Trial name
- NCT06528314
- Testing
- Efruxifermin
- Where
- 345 sites in United States, Argentina and 19 more
- Volunteers
- 2,150 people
- Sponsor
- Akero Therapeutics, Inc
Liver Cirrhosis
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
This study is open to adults with a type of confirmed liver condition called compensated cirrhosis due to Metabolic Dysfunction-Associated Steatohepatitis (MASH).
- Trial name
- NCT07325526
- Testing
- BI 3802876
- Where
- 27 sites in United States, Canada
- Volunteers
- 30 people
- Sponsor
- Boehringer Ingelheim
Metabolic Dysfunction-associated Steatohepatitis (MASH)
To Evaluate the Efficacy and Safety of QL2401 in Patients With Metabolic Dysfunction-associated Steatohepatitis and Liver Fibrosis
This is a Phase II, multicenter, randomized, double-blind, placebo-controlled, parallel-design clinical trial to evaluate efficacy and safety of QL2401 in patients with metabolic dysfunction-associated steatohepatitis and liver…
- Trial name
- NCT07620366
- Testing
- QL2401 25 mg, QL2401 50 mg, QL2401 100 mg
- Volunteers
- 132 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
MASLD, MASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease…
- Conditions
- MASLD, MASH, NASH, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Trial name
- FASCINIT (NCT06692283)
- Testing
- denifanstat
- Sponsor
- Sagimet Biosciences Inc.
MASH - Metabolic Dysfunction-Associated Steatohepatitis
A Trial to Investigate Safety, Exposure, and Efficacy of HU6 Compared With Placebo in Adult Participants With Metabolic Dysfunction-associated Steatohepatitis (MASH)
Rivus Pharmaceuticals. Inc. is sponsoring this research study to assess the safety and tolerability of HU6 as a possible treatment for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH).
- Trial name
- AMPLIFY (NCT07491458)
- Testing
- HU6
- Where
- 31 sites in United States
- Volunteers
- 180 people
- Sponsor
- Rivus Pharmaceuticals, Inc.
Metabolic Dysfunction-associated Steatohepatitis
A Pivotal Clinical Study to Investigate the Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
This study will investigate the safety and efficacy of efimosfermin alfa in participants with compensated cirrhosis due to MASH.
- Trial name
- NEBULA-1 (NCT07701993)
- Testing
- Efimosfermin alfa
- Where
- 15 sites in United States, Japan
- Volunteers
- 1,740 people
- Sponsor
- GlaxoSmithKline
NASH/MASH, NAFLD/MASLD
A Study Evaluating Efruxifermin in Subjects With Non-invasively Diagnosed Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Nonalcoholic Fatty Liver Disease (NAFLD)/Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The aim of this study is to assess the safety and tolerability of EFX compared to placebo in subjects with non-invasively diagnosed NASH/MASH and NAFLD/MASLD.
- Trial name
- NCT06161571
- Testing
- Efruxifermin
- Where
- 211 sites in United States, Argentina and 11 more
- Volunteers
- 700 people
- Sponsor
- Akero Therapeutics, Inc