At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 54 enrolled
Drug / intervention
Cotadutide +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized, Double-blind, Placebo-controlled, Proof-of-Concept Study to Evaluate the Safety and Efficacy of Cotadutide in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
In Brief
A Phase 2 clinical trial evaluating Cotadutide and Placebo for Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis. Completed, enrolled 54 participants across 115 sites in 20 countries.
Detailed Summary
The purpose of this study is to evaluate the safety and efficacy of cotadutide in participants with non-cirrhotic NASH with fibrosis.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Austria, Canada, France, Germany, Greece, Israel, Italy, Japan, Malaysia, New Zealand, South Africa, South Korea, Spain, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2023202420252026
First PostedMay 2022
Enrollment StartJul 2022
Primary CompletionApr 2024
TodayJul 2026
First PostedMay 6, 2022
Enrollment StartJul 14, 2022
Primary CompletionApr 19, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.2 years ago
Interventions
Cotadutidedrug
Cotadutide administered subcutaneously once daily
Placebodrug
Placebo administered subcutaneously once daily