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Melanotan-2

MT-II, Ac-Nle-cyclo[Asp-His-D-Phe-Arg-Trp-Lys]-NH2

Quick Stats
Studies 3
Trials 100
Active Not Recruiting PHASE3 INTERVENTIONAL NCT04822181

Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH)

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Semaglutide is a medicine studied in patients with NASH. Semaglutide is a well-known medicine, which is already used by doctors to treat type 2 diabetes in many countries. Participants will either get semaglutide or a dummy medicine - which treatment participants get is decided by chance. Participants will need to inject themselves with medicine under the skin. Participants will need to do this once a week. The study will last for about 5 years. Participants will have up to 21 clinic visits and 9 phone calls with the clinical staff during the study. Some of the clinic visits may be spread over more than one day. Participants with other chronic liver diseases cannot take part in this study. Women cannot take part in the study if they are pregnant, breast-feeding or plan to become pregnant during the study period.

Interventions

Name: Semaglutide
Type: DRUG
Description: Semaglutide administrated subcutaneously (under the skin) once weekly there will be a period of dose escalation before reaching the target dose.
Name: Placebo
Type: DRUG
Description: Placebo administrated subcutaneously (under the skin) once weekly.

Primary Outcomes

Measure: Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No)
TimeFrame: From randomisation (week 0) to week 72
Description: Count of subject
Measure: Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No)
TimeFrame: From randomisation (week 0) to week 72
Description: Count of subject
Measure: Part 2: Cirrhosis-free survival (Yes/No)
TimeFrame: From randomisation (week 0) to week 240
Description: Count of subject

Trial Information

NCT ID

NCT04822181

Status

Active Not Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE3

Sponsor

Novo Nordisk A/S

Last Updated

December 15, 2025

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