Clinical trials: Metabolic Dysfunction Associated Steatohepatitis (MASH)
- Condition Metabolic Dysfunction Associated Steatohepatitis (MASH)
- Funder type Industry (pharma, biotech, devices)
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
This study will test a study drug called ALN-PNP with and without another drug that is used for controlling blood sugar, appetite, and weight (for example, tirzepatide), to see if it can help treat MASLD, also known as fatty…
- Trial name
- NCT07527910
- Testing
- ALN-PNP, Tirzepatide
- Where
- 9 sites in United States
- Volunteers
- 204 people
- Sponsor
- Regeneron Pharmaceuticals
NASH With Fibrosis, MASH With Fibrosis
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with non-cirrhotic NASH/MASH and fibrosis stage 2 or 3 (F2 or F3).
- Trial name
- NCT06215716
- Testing
- Efruxifermin
- Where
- 359 sites in United States, Argentina and 16 more
- Volunteers
- 1,650 people
- Sponsor
- Akero Therapeutics, Inc
MASH
Phase 1/2 Study of OPK-88006 in Healthy and Presumed MASH Participants
Two-part Phase 1/2 study of OPK-88006, including an open-label SAD phase in healthy participants and a double-blind, randomized, placebo-controlled MAD phase in participants with presumed MASH, to evaluate safety, PK, and MASH…
- Trial name
- NCT07512427
- Testing
- OPK-88006
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- OPKO Health, Inc.
Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM)
Phase 1 Clinical Study of MWN105 Injection in Healthy Chinese Volunteers
This study is a randomized, double-blind, placebo-controlled, single-dose and multiple-dose, dose-escalation phase I clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic…
- Conditions
- Overweight , Obesity, Type 2 Diabetes Mellitus (T2DM), MASH - Metabolic Dysfunction-Associated Steatohepatitis
- Trial name
- NCT07801313
- Testing
- MWN105
- Where
- China
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Shanghai Minwei Biotechnology 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
MASH - Metabolic Dysfunction-Associated Steatohepatitis, Heart Failure With Preserved Ejection Fraction (HFPEF)
Resmetirom in Patients With MASH and HFpEF
This Phase 1b multicenter randomized double-blind placebo-controlled study evaluates the safety, tolerability and hepatic pharmacodynamic effects of resmetirom in adults with metabolic dysfunction-associated steatohepatitis…
- Trial name
- NCT07830758
- Testing
- Resmetirom
- Where
- 5 sites in United States
- Volunteers
- 90 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Evaluation of Miricorilant on Liver Fat in Patients With MASLD
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT06947304
- Testing
- Miricorilant
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Corcept Therapeutics
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 (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
- Trial name
- NCT06419374
- Testing
- Pegozafermin
- Where
- 330 sites in United States, Argentina and 23 more
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated Steatohepatitis
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
This Phase 1 trial will explore the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses of INI-822 in healthy volunteers in Parts A, B, D and F and in participants with a…
- Trial name
- NCT05945537
- Testing
- INI-822 (A)
- Where
- 11 sites in Australia
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- Inipharm Australia Pty Ltd
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-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
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.
MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis), Fatty Liver Disease, Nonalcoholic
Thermoacoustic Method for Estimating Liver Fat Fraction
The goal of this study is to use our Thermoacoustic Enhanced Ultrasound device to measure the fat levels in your liver and compare it to the the gold standard MRI PDFF measurements.
- Trial name
- NCT07321925
- Testing
- Thermoacoustic Enhanced Ultrasound
- Where
- United States
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Endra Lifesciences
Non-alcoholic Fatty Liver Disease
A Pivotal Clinical Study to Investigate Efimosfermin Alfa in Participants With Biopsy-confirmed F2- or F3-stage MASH
The purpose of this study is to assess the safety and efficacy of efimosfermin alfa in the resolution of steatohepatitis and improvement of liver-related clinical outcome compared to placebo in individuals with MASH and…
- Trial name
- ZENITH-1 (NCT07221227)
- Testing
- Efimosfermin alfa
- Where
- 91 sites in United States, Australia and 7 more
- Volunteers
- 1,200 people
- Sponsor
- GlaxoSmithKline
Healthy Volunteers, Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
A Trial to Learn if ALN-PNP is Safe and Well Tolerated in Healthy Adults and Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study is researching an experimental drug called ALN-PNP (called "study drug"). This is a first in human study. The study drug is not approved by any public health agency such as the United States Food and Drug…
- Trial name
- NCT05648214
- Testing
- ALN-PNP
- Where
- 6 sites in United States
- Volunteers
- 172 people, healthy volunteers welcome
- Sponsor
- Regeneron Pharmaceuticals
Metabolic Dysfunction Associated Steatohepatitis (MASH), Liver Fibrosis
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
This study is open to adults who are at least 18 years old living with obesity and have: a confirmed liver disease called non-alcoholic steatohepatitis (NASH)/metabolic associated steatohepatitis (MASH) and moderate or advanced…
- Trial name
- NCT06632444
- Testing
- Survodutide
- Where
- 532 sites in United States, Argentina and 35 more
- Volunteers
- 1,800 people
- Sponsor
- Boehringer Ingelheim
Metabolic Dysfunction-Associated Steatohepatitis(MASH)
Safety, Tolerability, PK, PD, and Immunogenicity of QL2401 in Healthy Chinese Adults
This is a first-in-human, Phase I, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of QL2401 following single and multiple…
- Trial name
- NCT07331545
- Testing
- QL2401
- Where
- China
- Volunteers
- 71 people, healthy volunteers welcome
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Study of VV-14303 for the Treatment of Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Study of VV-14303 for the Treatment of Metabolic dysfunction-associated steatohepatitis (MASH)
- Trial name
- RESTORE (NCT07732400)
- Testing
- VV-14303
- Where
- 3 sites in United States, New Zealand
- Volunteers
- 56 people
- Sponsor
- Kriya Therapeutics, Inc.
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.