The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis

Clinical Trial16 Jun 2026Phase 3

The Effect of Semaglutide in Subjects With Non-cirrhotic Non-alcoholic Steatohepatitis

Novo Nordisk A/S

Phase 3 trial evaluates semaglutide versus placebo in adults with non-cirrhotic NASH, measuring steatohepatitis resolution, fibrosis improvement, and cirrhosis-free survival over approximately 5 years. The study enrolled 1,205 adults and is active but not recruiting, with completion expected in 2029. This represents Novo Nordisk's push into NASH, a major unmet need with no approved GLP-1 therapies despite strong preclinical rationale. The trial's dual primary endpoints and 5-year duration suggest preparation for a pivotal regulatory filing in this large addressable market.

Strategic Signal

Novo positions semaglutide as the first GLP-1 in NASH ahead of tirzepatide, which lacks disclosed NASH programs despite superior metabolic efficacy. The 5-year endpoint duration and histological measures align with FDA guidance for NASH drug development, positioning for potential accelerated approval pathways. Success would create a new billion-dollar indication for semaglutide and establish GLP-1 precedent in hepatology before competitors enter.

GLP-1Liver/NASHNovo Nordisk

Original Abstract

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. | Condition(s): Non-alcoholic Steatohepatitis | Primary endpoint(s): Part 1: Resolution of steatohepatitis and no worsening of liver fibrosis (Yes/No); Part 1: Improvement in liver fibrosis and no worsening of steatohepatitis (Yes/No); Part 2: Cirrhosis-free survival (Yes/No) | Enrollment: 1,205 (actual) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2029-04-25 | Status: Active Not Recruiting | Last update: 2026-06-16

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