NCT07420283

A Study of Brenipatide in Participants With Opioid Use Disorder

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 465 (estimated)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if brenipatide, when compared to placebo, is safe and effective for participants with opioid use disorder, when used with buprenorphine with or without naloxone. The maximum potential duration of study participation for a participant in Part A is approximately 144 weeks, maximum potential duration of study participation for a participant in Part B is approximately 116 weeks. The actual duration will vary for each participant depending on the time of enrollment and the overall rate of study enrollment.

Detailed description

The study consists of 2 parts, each with its own participant cohort * Part A: double-blind treatment with open-label extension (OLE) * Part B: open-label treatment. Participants will be enrolled in only one part of the study.

Conditions

• Opioid Use Disorder

Interventions

Type	Name	Description
DRUG	Brenipatide	Administered SC
DRUG	Placebo	Administered SC
DRUG	Buprenorphine	Administered sublingual or buccal

Timeline

• Start date: 2026-03-12
• Primary completion: 2027-08-01
• Completion: 2028-02-01
• First posted: 2026-02-19
• Last updated: 2026-04-16

Locations

57 sites across 4 countries: United States, Canada, Puerto Rico, United Kingdom

Regulatory

• FDA-regulated drug study