Clinical trials: Metabolic Dysfunction-Associated Steatohepatitis
- Condition Metabolic Dysfunction-Associated Steatohepatitis
- Funder type Industry (pharma, biotech, devices)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, NAFLD - Non-Alcoholic Fatty Liver Disease
Development of a Quantifiable Ultrasound Biomarker for Hepatic Steatosis
The research study is considering a non-invasive way to measure the percentage of fat in the liver using ultrasound. This could help detect early signs of a very common condition called metabolic dysfunction-associated steatotic…
- Trial name
- LYNX (NCT07270601)
- Testing
- Verasonics NXT Data Acquisition System, Philips EPIQ Elite, EchoSense FibroScan
- Where
- United States
- Volunteers
- 110 people, healthy volunteers welcome
- Sponsor
- ContextVision AB
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
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
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
Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Study of UBT251 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 UBT251 in MASH subjects.
- Trial name
- MASH (NCT07145151)
- Testing
- UBT251
- Where
- China
- Volunteers
- 156 people
- Sponsor
- The United Bio-Technology (Hengqin) Co., Ltd.
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 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.
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
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
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.
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.
Metabolic Syndrome X, Fatty Liver
Evaluation of a New Ultrasound System for the Non-invasive Assessment of Liver Steatosis in MASLD/MASH Patients
The objective of the study is to evaluate an ultraportable ultrasound device, Hepatoscope, for the non-invasive assessment of hepatic steatosis in patients with metabolic-dysfunction associated liver diseases (MASLD), by…
- Conditions
- Metabolic Syndrome X, Fatty Liver, MASH - Metabolic Dysfunction-Associated Steatohepatitis, MASLD
- Trial name
- ACOUSTIQ (NCT06661655)
- Testing
- Liver ultrasound
- Where
- 3 sites in France
- Volunteers
- 120 people
- Sponsor
- E-Scopics
Metabolic Dysfunction-Associated Steatohepatitis
A Trial to Evaluate the Efficacy and Safety of ARO-INHBE in Adults With Metabolic Dysfunction-Associated Steatohepatitis
This study is designed to evaluate the safety and efficacy of ARO-INHBE in adults with suspected metabolic dysfunction-associated steatohepatitis (MASH).
- Trial name
- NCT07859813
- Testing
- ARO-INHBE
- Volunteers
- 252 people
- Sponsor
- Arrowhead Pharmaceuticals
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
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.
Healthy Participants, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Study of TGM-312-SC01 in Healthy Participants and Adults With MASH
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single ascending doses of TGM-312-SC01 in healthy adults and multiple ascending doses in patients with…
- Trial name
- NCT07427680
- Testing
- TGM-312-SC01
- Where
- United Kingdom
- Volunteers
- 99 people, healthy volunteers welcome
- Sponsor
- Tangram Therapeutics Plc
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 Fatty Liver Disease
Evaluate the Effect of Synbiotics on MAFLD
Non-alcoholic fatty liver disease (NAFLD) is one of the most common chronic liver diseases worldwide. Available data indicates that probiotics may regulate the gut microbiota, while Vitamin E and omega 3 are safe and effective at…
- Trial name
- MAFLD-RCT (NCT06537882)
- Testing
- G-NiiB synbiotics formula (SLP07)
- Where
- Hong Kong
- Volunteers
- 54 people
- Sponsor
- GenieBiome Limited
Metabolic Dysfunction-Associated Steatohepatitis (MASH)
To Evaluate the Tolerability, Pharmacokinetics, and Pharmacodynamics of IMM-H014 in Patients With MASH
This study will evaluate the tolerability, pharmacokinetics, and pharmacodynamics of consecutive Multiple treatment for 12 weeks（84 Days） in Adult Patients with Metabolic Dysfunction-Associated Steatohepatitis.
- Trial name
- NCT07016633
- Testing
- IMM-H014
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Changchun Intellicrown Pharmaceutical Co. LTD
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