Study S001202

Efficacy and Safety Investigation of NNC0194-0499 Co-administered With Semaglutide in Subjects With Non-alcoholic Steatohepatitis: a Dose-ranging, Placebo Controlled Trial

Name: LivingGLP1 adjudicated trial data and network meta-analysis results
Creator: Ahmad Sofi-Mahmudi
License: https://creativecommons.org/licenses/by/4.0/

ClinicalTrials.gov record

Registration

Registration: NCT05016882
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: QUADRUPLE
Status: COMPLETED
Enrollment: 698
Start: 2021-08-31
Primary completion: 2024-12-17
Lead sponsor: Novo Nordisk A/S
Conditions: Non-alcoholic Steatohepatitis
Interventions: DRUG:NNC0194 0499 50 mg/mL; DRUG:Placebo (NNC0194-0499); DRUG:Semaglutide 3 mg/mL; DRUG:Semaglutide placebo; DRUG:NNC0174 0833 10 mg/mL; DRUG:NNC0174 0833 placebo
Results posted: FALSE
Individual participant data sharing: YES
Secondary identifiers: OTHER:U1111-1255-5551; EUDRACT_NUMBER:2020-003566-39

Registered primary outcomes

Improvement in liver fibrosis and no worsening of NASH (Yes/No) [From baseline (week 0) to week 52]

Linked records (2)

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
R0009090	Efficacy and safety of zalfermin co-administered with semaglutide in participants with fibrosis and cirrhosis due to metabolic dysfunction-associated steatohepatitis: a phase 2, dose-ranging, double-blind, randomised controlled trial. Loomba R, The lancet. Gastroenterology & hepatology	2026	Randomized trial	PMID 42456707 DOI	cites ClinicalTrials.gov:NCT05016882; registry reference DERIVED:42456707
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:NCT05016882