Clinical trials: Metabolic Associated Fatty Liver Disease
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
Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3
Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis)
This study is designed to establish the effect of 2 doses of vonafexor on the kidney. This will be investigated in subjects with mild or moderate reduced estimated glomerular filtration rate (eGFR) and suspected MASH.
- Conditions
- Chronic Kidney Disease Stage 2, Chronic Kidney Disease Stage 3, Metabolic Dysfunction-Associated Steatohepatitis
- Trial name
- MASH (NCT06939816)
- Testing
- Vonafexor low dose, Vonafexor high dose
- Where
- Germany
- Volunteers
- 10 people
- Sponsor
- Enyo Pharma
Overweight/Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH)
A Single-Dose Pharmacokinetic Study of HRS-4729 Injection in Healthy Participants and Patients With Renal Impairment
This study aims to evaluate the pharmacokinetic effects of a single dose of HRS-4729 injection in participants with mild, moderate, and severe renal impairment, with 8 participants enrolled in each renal impairment group and 8…
- Conditions
- Overweight/Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease/Steatohepatitis (MASLD/MASH), Type 2 Diabetes Mellitus
- Trial name
- NCT07807059
- Testing
- HRS-4729
- Where
- China
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Overweight, Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD)
A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD）
This is a multicenter, randomized, open-label Phase 3 clinical study comparing the efficacy and safety of IBI362 9 mg QW versus Semaglutide 2.4 mg QW in overweight or obese (BMI≥27kg/m2) MAFLD subjects.
- Trial name
- NCT06884293
- Testing
- IBI362, semaglutide
- Where
- China
- Volunteers
- 479 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)
A Single-Ascending and Repeated Dose Study of LY3849891 in Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
The main purpose of this study is to evaluate the safety and tolerability of the study drug LY3849891 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD) who have the patatin-like phospholipase…
- Trial name
- NCT05395481
- Testing
- LY3849891
- Where
- 16 sites in United States, Japan and 1 more
- Volunteers
- 115 people
- Sponsor
- Eli Lilly and Company
MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)
Study of TVB-2640 in Subjects With Non-Alcoholic Steatohepatitis (NASH)
This is a Phase 2 multi-center, randomized, single-blind, placebo-controlled study to evaluate the safety and efficacy of TVB-2640 in subjects with non-alcoholic steatohepatitis (NASH), a type of fatty liver disease.
- Trial name
- NCT03938246
- Testing
- TVB-2640 25 mg (US), TVB-2640 50 mg (US), TVB-2640 50 mg (China)
- Where
- 23 sites in United States, China
- Volunteers
- 142 people
- Sponsor
- Sagimet Biosciences Inc.
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
This study will test a Regeneron study drug called ALN-CIDEB to find out whether it may help treat a liver disease called metabolic dysfunction-associated steatohepatitis (MASH).
- Trial name
- NCT07854782
- Testing
- ALN-CIDEB
- Volunteers
- 1,500 people
- Sponsor
- Regeneron Pharmaceuticals
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
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
MASH - Metabolic Dysfunction-Associated Steatohepatitis, NASH (Non-Alcoholic Steatohepatitis)
A Phase 3 Study Evaluating the Safety and Efficacy of HSK31679 in Patients With MASH
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of HSK31679 compared to placebo in patients with metabolic dysfunction-associated steatohepatitis (MASH) .
- Trial name
- NCT07581951
- Testing
- HSK31679
- Where
- China
- Volunteers
- 886 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Intestinal Failure-associated Liver Disease
Prevalence of Liver Disease in Patients Dependent on Parenteral Nutrition
This is a multi-center prospective cross-sectional observational study that will assess the prevalence of liver disease in patients dependent on parenteral nutrition (PN) for 4 or more days per week.
- Trial name
- THRIVE-1 (NCT05011370)
- Where
- 15 sites in United States, Denmark and 2 more
- Volunteers
- 80 people
- Sponsor
- Protara Therapeutics
Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
This study will demonstrate safety in pediatric patients with Parenteral Nutrition-Associated Cholestasis treated with Omegaven®, which is indicated as a source of calories and fatty acids in this patient population
- Conditions
- Parenteral Nutrition Associated Liver Disease (PNALD), Essential Fatty Acid Deficiency, Malnutrition, Pediatric ALL
- Trial name
- NCT06274788
- Testing
- Omegaven® (fish oil triglycerides) Injectable Emulsion
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Fresenius Kabi
Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis
Tesamorelin for Reduction of Liver Fat in Adults With Fatty Liver Disease (Mock Study)
This randomized, double-blind, placebo-controlled Phase II study evaluates whether daily subcutaneous tesamorelin (a growth hormone-releasing hormone analog) reduces liver fat in adults with fatty liver disease.
- Conditions
- Metabolic Associated Steatotic Liver Disease, Nonalcoholic Steatohepatitis, Hepatic Steatosis
- Trial name
- TESA-LIVER (NCT07481734)
- Testing
- Tesamorelin, Standardized lifestyle counseling
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Hudson Biotech
Non-alcoholic Fatty Liver Disease
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic…
- Trial name
- NCT07358546
- Testing
- Efimosfermin alfa
- Where
- 3 sites in United States
- Volunteers
- 32 people
- Sponsor
- GlaxoSmithKline
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) & Steatohepatitis (MASH)
A Real-world Assessment in Implementation of the MASH Patient Care Pathway in Chinese Population Using the Meinian Health Check-up Database
The primary objective of this study is to estimate the proportion of people with low/intermediate/high risk of advanced fibrosis in at risk Chinese population based on the European Association for the Study of the Liver (EASL)…
- Trial name
- IMPACT MASH (NCT06741111)
- Testing
- No treatment given
- Where
- India
- Volunteers
- 1,233,970 people
- Sponsor
- Novo Nordisk A/S
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.
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver Disease, Nonalcoholic
Investigation of the Efficacy of a Probiotic Mixture in Moderate Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD): A Mechanistic Trial
The goal of this clinical trial is to evaluate whether a specific probiotic mixture can improve liver health in adults with moderate metabolic dysfunction-associated steatotic liver disease (MASLD).
- Conditions
- MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, Fatty Liver Disease, Nonalcoholic, Overweight (BMI > 25)
- Trial name
- NCT07193927
- Testing
- Lactiplantibacillus plantarum Probiotic Mixture
- Where
- Spain
- Volunteers
- 60 people
- Sponsor
- AB Biotics, SA
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
This study is for adults aged 18 years and older who have a type of fatty liver disease called metabolic dysfunction-associated steatotic liver disease (MASLD).
- Trial name
- NCT07850063
- Testing
- Survodutide
- Where
- 34 sites in United States, China and 3 more
- Volunteers
- 600 people
- Sponsor
- Boehringer Ingelheim