Clinical trials: MASH
Metabolic Dysfunction-Associated Steatotic Liver Disease
Developing Microbial Therapy for MASLD: From Mechanism to Clinical Validation
Metabolic dysfunction-associated steatotic liver disease (MASLD), redefined in 2020, is an improved diagnostic standard evolved from non-alcoholic fatty liver disease (NAFLD), emphasizing the correlation between hepatic steatosis…
- Trial name
- MASLD (NCT07488975)
- Testing
- Pasteurized Akkermansia muciniphila LWHK0003_low dose, Pasteurized Akkermansia muciniphila LWHK0003_medium dose, Pasteurized Akkermansia muciniphila LWHK0003_high dose
- Where
- Taiwan
- Volunteers
- 40 people
- Sponsor
- Leeuwenhoek Laboratories Co. Ltd.
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.
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.
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
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
This study is open to adults who are at least 18 years old and have: A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or A confirmed liver disease called metabolic-associated steatohepatitis (MASH) BMI of 27…
- Trial name
- NCT06632457
- Testing
- Survodutide
- Where
- 446 sites in United States, Argentina and 34 more
- Volunteers
- 1,590 people
- Sponsor
- Boehringer Ingelheim
MASH - Metabolic Dysfunction-Associated Steatohepatitis
Study to Evaluate Resmetirom in Post-Liver Transplant Patients With MASH
A Phase 2 double-blind, randomized, placebo-controlled study to evaluate resmetirom in 2 cohorts of subjects with moderate to advanced fibrosis, consistent with stage F2 and F3 fibrosis, who have undergone liver transplant.
- Trial name
- NCT07335601
- Testing
- Resmetirom
- Where
- 17 sites in United States, Canada
- Volunteers
- 120 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
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
Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Study of IBI362 in Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH)
This is a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study evaluating the efficacy and safety of IBI362 in MASH subjects.
- Trial name
- NCT06937749
- Testing
- IBI362
- Where
- China
- Volunteers
- 181 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
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
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
NAFLD (Non-alcoholic Fatty Liver Disease)
A Trial to Evaluate the Efficacy, Safety, PK, and PD of HP515 in Non - Alcoholic Fatty Liver Disease ( NASH/MASH )
Primary Objective: To evaluate the efficacy of HP515 tablets in participants with non-alcoholic fatty liver disease. Secondary objectives: To evaluate the safety of HP515 tablets in participants with non-alcoholic fatty liver…
- Trial name
- NASH/MASH (NCT07308548)
- Testing
- HP515 10 mg Tablet, HP515 20 mg Tablet
- Where
- 2 sites in China
- Volunteers
- 80 people
- Sponsor
- Hinova Pharmaceuticals Inc.
Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Multi-country, Cross-sectional Quantitative Study Exploring Awareness, Understanding, and Perceptions of the Relation Between Cardiorenal Metabolic Conditions and MASLD/MASH Among Healthcare Providers, People With MASLD/MASH, and At-risk Population
The purpose of this study is to collect information for scientific research and to better understand awareness and to understand overall risk awareness, diagnoses and treatment related to liver related diseases.
- Trial name
- MASH (NCT07201831)
- Testing
- No treatment given
- Where
- 5 sites in United States, Canada and 3 more
- Volunteers
- 1,330 people
- Sponsor
- Novo Nordisk A/S
MASH, PSC
A Microdose Trial Investigating Binding of [68Ga]Ga-DOTA-CYS-ATH001 in Healthy Subjects and Different Patient Groups.
The goal of this clinical trial is to use positron emission tomography (PET) to evaluate and compare the binding of the novel tracer [68Ga]Ga-DOTA-Cys-ATH001 in the liver and/or gastrointestinal tract between healthy volunteers…
- Conditions
- MASH, PSC, Fibrostenotic Crohn's Disease, Healthy Volunteers
- Trial name
- NCT06562361
- Testing
- [68Ga]Ga-DOTA-Cys-ATH001
- Where
- 3 sites in Sweden
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Antaros Medical
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
- 531 sites in United States, Argentina and 34 more
- Volunteers
- 1,800 people
- Sponsor
- Boehringer Ingelheim
MASH
A Study to Assess the Safety, Pharmacokinetics, and Activity of RO7790121 in Participants With Advanced MASH Liver Fibrosis
The purpose of this study is to assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity and activity of RO7790121 in participants with advanced metabolic dysfunction-associated steatohepatitis (MASH)…
- Trial name
- NCT06903065
- Testing
- RO7790121
- Where
- 15 sites in United States, Mexico and 1 more
- Volunteers
- 56 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-associated Steatohepatitis
A Study of a Thyroid Hormone Receptor Beta Isoform (THRβ) Agonist and an Semicarbazide Sensitive Amine Oxidase (SSAO) Inhibitor, Alone and in Combination, in Adults With Presumed Metabolic Dysfunction-associated Steatohepatitis (MASH)
The primary objective of this trial is to evaluate the dose-dependent and comparative effects of ECC4703 (low and high dose), ECC0509 (low and high dose), and their combination on hepatic fat reduction as assessed by change in…
- Trial name
- NCT07288138
- Testing
- ECC4703, ECC0509
- Where
- 68 sites in United States
- Volunteers
- 160 people
- Sponsor
- Eccogene
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
Metabolic Dysfunction-associated Steatotic Liver Disease
Digital Pathology and AI for Liver Outcomes in MASLD (DPAILO-2)
The aim of this multi-center, retrospective epidemiologic study is to confirm the prognostic performance of the Digital Pathology (DP) FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS), derived from standard digital…
- Trial name
- NCT06493253
- Testing
- Digital Pathology FibroNest Phenotypic Fibrosis Composite Score (Ph-FCS)
- Where
- United States
- Volunteers
- 1,519 people
- Sponsor
- PharmaNest, Inc
Metabolic Dysfunction-associated Steatohepatitis
A Study to Investigate Safety and Efficacy of Efimosfermin Compared With Placebo in Adult Participants With Compensated Cirrhosis Due to Metabolic Dysfunction-associated Steatohepatitis (MASH)
This is a multi-center, randomized, two-part (Part A and Part B) study investigating the safety and efficacy of efimosfermin alfa in adult participants with compensated cirrhosis due to MASH.
- Trial name
- NEBULA-2 (NCT07704892)
- Testing
- Efimosfermin alfa
- Where
- 20 sites in United States, Japan
- Volunteers
- 380 people
- Sponsor
- GlaxoSmithKline
MASLD, MASH
Endoscopic Ultrasound Shear Wave Elastography Study
This study shall be a prospective, multicenter, single arm, consecutive, interventional study conducted in a post-market setting using commercially available devices.
- Conditions
- MASLD, MASH, Fibrosis, Liver, Chronic Liver Disease
- Trial name
- EUS-SWE (NCT06592820)
- Testing
- Endoscopic Ultrasound Shear Wave Elastography (EUS) and Attenuation Imaging, FibroScan, Liver biopsy
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- Olympus Corporation of the Americas