Brenipatide for Opioid Use Disorder
(RENEW-Op-1 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Principal Investigator
Eli Lilly and Company
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Part A)
Double-blind treatment with Brenipatide or placebo plus Buprenorphine
Open-label Extension (Part A)
Participants may opt into continuation of treatment with Brenipatide and Buprenorphine
Treatment (Part B)
Open-label treatment with Brenipatide and Buprenorphine
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Brenipatide
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Placebo Group
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
Part A: Brenipatide administered subcutaneously (SC) + Buprenorphine administered sublingual or buccal. Part B: Open-label Treatment: Participants will receive Brenipatide SC + Buprenorphine sublingual or buccal.
Placebo administered SC + Buprenorphine administered sublingual or buccal.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
David A. Ricks
Eli Lilly and Company
Chief Executive Officer since 2017
BSc from Purdue University, MBA from Indiana University
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