Study S000922

This Trial is Conducted Globally. The Aim of This Trial is to Investigate Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT02970942
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 320
Start: 2016-11-30
Primary completion: 2020-02-13
Lead sponsor: Novo Nordisk A/S
Conditions: Hepatobiliary Disorders; Non-alcoholic Steatohepatitis
Interventions: DRUG:Semaglutide; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: EUDRACT_NUMBER:2016-000685-39; OTHER:U1111-1179-7464; NIH:2016

Registered primary outcomes

Percentage of Participants With Non- Alcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 72 Weeks (Yes/No) [After 72 weeks]

Linked records (9)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0016401	Exploration of Multiple Non-Invasive Tests for Assessing Response to Treatment in a Semaglutide Phase 2b Trial in Patients with MASH. Nitze LM, Alimentary pharmacology & therapeutics	2026	Randomized trial	PMID 40985232 DOI	cites ClinicalTrials.gov:NCT02970942; registry reference DERIVED:40985232
R0011424	Similar weight loss with semaglutide regardless of diabetes and cardiometabolic risk parameters in individuals with metabolic dysfunction-associated steatotic liver disease: Post hoc analysis of three randomised controlled trials. Armstrong MJ, Diabetes, obesity & metabolism	2025	Randomized trial	PMID 39609879 DOI	cites ClinicalTrials.gov:NCT02970942
R0017195	Proteomic signatures reflect effects of semaglutide treatment for MASH. Schattenberg JM, JHEP reports : innovation in hepatology	2025	Randomized trial	PMID 40980163 DOI	cites ClinicalTrials.gov:NCT02970942; registry reference DERIVED:40980163
R0020474	Artificial intelligence scoring of liver biopsies in a phase II trial of semaglutide in nonalcoholic steatohepatitis. Ratziu V, Hepatology (Baltimore, Md.)	2024	Randomized trial	PMID 38112484 DOI	cites ClinicalTrials.gov:NCT02970942; registry reference DERIVED:38112484
R0008796	Improved health-related quality of life with semaglutide in people with non-alcoholic steatohepatitis: A randomised trial. Romero-Gómez M, Alimentary pharmacology & therapeutics	2023	Randomized trial	PMID 37328931 DOI	cites ClinicalTrials.gov:NCT02970942; registry reference DERIVED:37328931
R0021117	FibroScan-aspartate aminotransferase (FAST) score for monitoring histological improvement in non-alcoholic steatohepatitis activity during semaglutide treatment: post-hoc analysis of a randomised, double-blind, placebo-controlled, phase 2b trial. Wai-Sun Wong V, EClinicalMedicine	2023	Randomized trial	PMID 38058795 DOI	cites ClinicalTrials.gov:NCT02970942; registry reference DERIVED:38058795
R0049133	The Effect of Semaglutide on Kidney Function: Post Hoc Analysis of Three Randomized Controlled Trials in Non-Alcoholic Fatty Liver Disease Katherine R. Tuttle, Journal of the American Society of Nephrology	2022	Randomized trial	DOI	cites ClinicalTrials.gov:NCT02970942
R0012449	A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. Newsome PN, The New England journal of medicine	2021	Randomized trial	PMID 33185364 DOI	cites ClinicalTrials.gov:NCT02970942; registry reference RESULT:33185364
R0024603	Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers. Harrison SA, Contemporary clinical trials	2020	Protocol	PMID 33039693 DOI	cites ClinicalTrials.gov:NCT02970942; registry reference DERIVED:33039693