Metabolic Dysfunction Associated Steatohepatitis

9

Review clinical trials related to Metabolic Dysfunction Associated Steatohepatitis. Use filters to narrow results by trial status, phase, treatment, biological sex and sponsor.

Condition / disease
Location
Status: Recruiting

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 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian. People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function. Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.

Participants needed: 1,590
Trial details
Phase: Phase 3Age: 18+Biological sex: AllType: InterventionalSponsor: Boehringer IngelheimUpdated: Jun 24, 2026Locations: 444
Eligibility criteria

Male or female adults ≥18 years of age at the time of screening, and at least th... [+4]

Current or history (<5 years) of significant alcohol consumption, defined as an... [+18]

Status: Recruiting

Effect of Endoscopic Sleeve Gastroplasty in Patients With Obesity and MASH: A Randomized Controlled Trial

Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease globally. While weight loss through lifestyle modification is the standard treatment, most patients regain weight limiting ultimate improvement in liver disease. On the other end of the spectrum, bariatric surgery has shown promise in the treatment of MASLD/metabolic dysfunction-associated steatohepatitis (MASH) due to its efficacy in inducing weight loss. Nevertheless, its adoption has been hindered by the perceived invasiveness of surgery. Over the past decade, endoscopic sleeve gastroplasty (ESG) has gained recognition as a promising minimally-invasive approach to weight loss. The procedure involves utilizing a Food and Drug Administration (FDA)-authorized endoscopic suturing device to reduce the gastric volume by 70%. Studies reveal that ESG is associated with approximately 18.2% weight loss at one year after the procedure, with sustained results for at least 10 years. Nevertheless, the effect of ESG on MASH remains unknown. In this study, the investigators will compare ESG + lifestyle modification versus lifestyle modification alone in treating histologic MASH. The study will randomize patients to one of two different treatment options: ESG + lifestyle modification or lifestyle modification alone.

Participants needed: 132
Trial details
Age: 18+Biological sex: AllType: InterventionalSponsor: Pichamol Jirapinyo, MD, MPHUpdated: Jun 25, 2026Locations: 2
Eligibility criteria

Age ≥ 18 (male or female) [+7]

Known history of other chronic liver diseases (viral hepatitis, autoimmune hepat... [+28]

Status: Recruiting

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 magnetic resonance imaging proton density fat fraction (MRI-PDFF) at Week 12.

Participants needed: 160
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: EccogeneUpdated: Jun 5, 2026Locations: 58
Eligibility criteria

Adults between 18 and 75 years of age, inclusive, who can provide written inform... [+8]

Chronic liver disease other than metabolic dysfunction-associated steatotic live... [+9]

Status: Recruiting

A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)

This study is researching an experimental drug called ALN-CIDEB, also referred to as "study drug". The study is focused on participants with metabolic dysfunction-associated steatotic liver disease (MASLD) (Part A) and metabolic dysfunction-associated steatohepatitis (MASH) (Part B). MASLD and MASH are long-lasting liver conditions caused by having too much fat in the liver. The aim of the study is to see how safe and tolerable the study drug is. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How the study drug works to change liver fat content * How much study drug and study drug metabolites (byproducts of the body breaking down the study drug) are in the blood at different times

Participants needed: 132
Trial details
Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Regeneron PharmaceuticalsUpdated: Apr 27, 2026Locations: 3
Eligibility criteria

Part A: 18 to 55 years at Screening Visit 1 with MASLD, at Screening Visit 1 Par... [+6]

Known historical or current diagnosis of portal hypertension or cirrhosis based... [+8]

Status: Not yet recruiting

Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic(PK/PD) Profile of ACT500 in Metabolic Dysfunction-Associated Steatotic Liver Disease(MASLD)

This study is a multicenter, open-label, dose-escalation trial designed to evaluate the safety, tolerability, PK, and PD profiles of ACT500 in participants with metabolic dysfunction-associated steatotic liver disease (MASLD). The trial plans to enroll approximately 24 MASLD participants across four dose cohorts, each consisting of 6 participants who will receive oral ACT500 once daily.

Participants needed: 24
Trial details
Phase: Phase 1Age: 18-69Biological sex: AllType: InterventionalSponsor: Xiamen Amoytop Biotech Co., Ltd.Updated: Mar 17, 2026Locations: 4
Eligibility criteria

The participant fully understands the purpose, nature, methods, and possible adv... [+12]

[1] Combined with other liver diseases, including but not limited to hepatitis B...

Status: Recruiting

ECC4703 Food Effect and Relative Bioavailability Study in Healthy Adult Participants

This is a Phase I, open-label, randomized, single-dose, 2-part study designed to evaluate the food effect and relative bioavailability of ECC4703 in healthy adult participants.

Participants needed: 72
Trial details
Phase: Phase 1Age: 18-65Biological sex: AllType: InterventionalSponsor: EccogeneUpdated: Jan 16, 2026Locations: 1
Eligibility criteria

Healthy male and female participants [+8]

Females who are pregnant, planning to become pregnant, or breastfeeding during t... [+10]

Status: Recruiting

Study of the Link Between MASH ( Metabolic Dysfunction-Associated Steatohepatitis) and MAMs (Mitochondria-Associated Membranes ) Alteration in Patients Undergoing Bariatric Surgery - MAMBA

The main research hypothesis is that alterations in the communication between the endoplasmic reticulum (ER) and the mitochondria at contact sites called mitochondria-associated membranes (MAMs) occurs in different hepatic cell types of patients with Metabolic Dysfunction-Associated Steatotic Liver Disease (MALSD) and is involved in the progression towards MASH and could also influence the process of improvement of MASH. This study aims to investigate the link between Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Mitochondria-Associated Membranes (MAMs) in liver cells and peripheral blood mononuclear cells (PBMCs) in patients undergoing bariatric surgery. The primary objective is to analyze MAMs alterations in hepatocytes in MASH patients compared to non-MASH patients. Secondary objectives include evaluating the correlation between MAMs in PBMCs and liver cells and assessing MAMs changes post-bariatric surgery.

Participants needed: 20
Trial details
Age: 18-99Biological sex: AllType: ObservationalSponsor: Hospices Civils de LyonUpdated: Jan 15, 2026Locations: 2
Eligibility criteria

Female or male adult patients [+4]

Patient presenting Hepatitis B as defined as presence of hepatitis B surface ant... [+22]

Status: Recruiting

A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH

The purpose of this study is to evaluate the safety, tolerability, preliminary efficacy, and pharmacokinetics (PK) of efimosfermin in participants with metabolic dysfunction associated steatohepatitis (MASH) and compensated cirrhosis consistent with stage F4 fibrosis.

Participants needed: 42
Trial details
Phase: Phase 2Age: 18-75Biological sex: AllType: InterventionalSponsor: Boston PharmaceuticalsUpdated: Dec 24, 2025Locations: 35
Eligibility criteria

Ability to understand and sign a written informed consent form (ICF) [+4]

Individuals with chronic liver disease from other causes, or any history or evid... [+3]

Status: Recruiting

Prognostic Factors for HCC and Liver Transplantation in Patients With MASLD/MASH

The BOMASH study is a single-center, prospective/retrospective observational study without pharmacological interventions. It will include all patients diagnosed with Metabolic-Associated Steatotic Liver Disease (MASLD/MASH), whether newly diagnosed or previously identified at the center during follow-up or as part of routine diagnostic and therapeutic care. The aim of the study is to identify predictive factors related to the prognosis of patients with metabolic liver disease (MASLD/MASH). Specifically, the study seeks to uncover biomarkers that can identify individuals at risk of requiring a liver transplant or developing HCC.

Participants needed: 1,000
Trial details
Age: 18+Biological sex: AllType: ObservationalSponsor: IRCCS Azienda Ospedaliero-Universitaria di BolognaUpdated: Feb 7, 2025Locations: 1Duration: 6 Months
Eligibility criteria

All patients with a diagnosis of MASLD, established according to the most recent... [+2]

No exclusion criteria.