Study S002293

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacodynamic Effects of MEDI0382 in Obese Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)/ Non-Alcoholic Steatohepatitis (NASH)

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT04019561
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: TRIPLE
Status: COMPLETED
Enrollment: 74
Start: 2019-09-23
Primary completion: 2021-05-06
Lead sponsor: MedImmune LLC
Conditions: Non-alcoholic Fatty Liver Disease (NAFLD); Non-alcoholic Steatohepatitis (NASH)
Interventions: DRUG:MEDI0382 high dose; DRUG:Placebo for MEDI0382 high dose; DRUG:MEDI0382 low dose; DRUG:Placebo for MEDI0382 low dose
Results posted: TRUE
Individual participant data sharing: YES

Registered primary outcomes

Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE [Day 1 - Day 161]

Linked records (1)

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
R0016750	Safety and Efficacy of Novel Incretin Co-agonist Cotadutide in Biopsy-proven Noncirrhotic MASH With Fibrosis. Shankar SS, Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association	2024	Randomized trial	PMID 38729399 DOI	cites ClinicalTrials.gov:NCT04019561; registry reference DERIVED:38729399