Study S001764

Investigation of Efficacy and Safety of Semaglutide s.c. Once-weekly Versus Placebo in Subjects With Non-alcoholic Steatohepatitis and Compensated Liver Cirrhosis

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

Registration

Registration: NCT03987451
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 71
Start: 2019-06-18
Primary completion: 2021-04-22
Lead sponsor: Novo Nordisk A/S
Conditions: Non-alcoholic Steatohepatitis
Interventions: DRUG:Semaglutide; DRUG:Placebo (semaglutide)
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1224-4062; REGISTRY:2018-004484-31; NIH:2018

Registered primary outcomes

Percentage of Participants With At Least One Stage of Liver Fibrosis Improvement With No Worsening of Non-Alcoholic Steatohepatitis (NASH) After 48 Weeks [Week 48]

Linked records (4)

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
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:NCT03987451
R0017043	Semaglutide 2·4 mg once weekly in patients with non-alcoholic steatohepatitis-related cirrhosis: a randomised, placebo-controlled phase 2 trial. Loomba R, The lancet. Gastroenterology & hepatology	2023	Randomized trial	PMID 36934740 DOI	cites ClinicalTrials.gov:NCT03987451; registry reference BACKGROUND:36934740
R0040528	From cause to consequence: Insights into incident diabetes mellitus after hepatic steatosis Manik Aggarwal, Clinical Liver Disease	2023	Other	PMID 36938314 DOI	cites ClinicalTrials.gov:NCT03987451
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:NCT03987451