J2S-MC-GZMG
Research type
Research Study
Full title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study with a Separate Open-label Cohort to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Transmucosal Buprenorphine with or without Naloxone in Early Recovery of Participants with Opioid Use Disorder (RENEW-Op-1)
IRAS ID
1013119
Contact name
Tetiana Rudenok
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
Short title of this project: A Study to Evaluate the Efficacy and Safety of Brenipatide as Adjunctive Treatment to Buprenorphine with or without Naloxone in Early Recovery of Participants with Opioid Use Disorder (RENEW-Op-1)
The purpose of this study is to assess the efficacy and safety of Brenipatide at different dose levels compared with placebo as an add-on treatment to Buprenorphine with or without Naloxone, in participants with Opioid Used Disorder (OUD) who are in early recovery. The results from this study will help researchers to decide on how to continue developing Brenipatide in the future. This study includes the following study periods:
· Screening period
· Double blind treatment period
. Open label extension
· Post treatment safety follow-up period.
The study will enroll participants from 18 to 75 years of age (inclusive) who have OUD. Study participants will be excluded based on conditions that could interfere with study assessments or increase a participant’s risk of experiencing side effects during the study. A total of 372 participants will be enrolled in this study.REC name
London - City & East Research Ethics Committee
REC reference
26/LO/0135
Date of REC Opinion
9 Mar 2026
REC opinion
Further Information Favourable Opinion