*PROXYMO-ADVANCE
Research type
Research Study
Full title
A Phase IIb/III Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Cotadutide in Participants with Non-cirrhotic Non-alcoholic Steatohepatitis with Fibrosis
IRAS ID
1005285
Contact name
Nicola Weston
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2021-005484-53
Clinicaltrials.gov Identifier
Research summary
This two-part study will assess safety, tolerability, and effectiveness of cotadutide in adults with NASH (liver fat and inflammation) and liver fibrosis (scarring).
NASH affects approximately 2-3% of the general population, often without symptoms, and can lead to liver scarring, end-stage liver disease, and liver cancer. Cotadutide has been evaluated in multiple studies and has been found to be safe in over 1000 participants with benefits in liver health, weight loss, glucose and lipid levels.
Eligible participants will be ≥18 to ≤ 75 years of age with NASH with fibrosis diagnosed by biopsy. Participants with type 2 diabetes should be well controlled. In both parts, participants will undergo clinic visits, laboratory/imaging studies, liver biopsy (at Week 48 in Part A, Week 84 Part B), EKGs, and potentially other measures. There will be no more than two liver biopsies for either part of the study. Participants will administer cotadutide or placebo subcutaneously (under the skin) daily, with prefilled pen device.
In Part A, participants will receive one of two doses of cotadutide or placebo. Part A will last for 96 weeks and allow for assessment of cotadutide and choosing an optimal dose for NASH improvement.
Part B recruitment will start after recruitment for Part A is completed. Participants will receive one of two doses of cotadutide or placebo; dosing may change based on Part A results. This part will allow for assessment of improvements in NASH and fibrosis. Participants will have an option to undergo non-invasive measures of NASH and fibrosis and complete quality-of-life questionnaires. Part B will last for a minimum of 96 weeks; the time may vary so that everyone receives intervention for 84 weeks. The longest time a participant is expected to be in the study is 156 weeks, but this may change depending on enrollment.Lay Summary of Results
Technical results are still being drafted and will be posted alongside the study protocol within these registries above by 18th Apr 2025. Study Protocol, SAP and CSR synopsis will be part of results posting.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
22/SW/0119
Date of REC Opinion
4 May 2022
REC opinion
Further Information Favourable Opinion