A Study of Brenipatide in Participants With Opioid Use Disorder

Last updated:
2026-08-15
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View trial details

Overview

Official protocol 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)

Intervention/treatment:
BRENIPATIDE (LY3537031) / BUPRENORPHINE-NALOXONE
Medical condition:
OPIOID USE DISORDER
Protocol code:
J2S-MC-GZMG
Control number:
303689
Status:
Recruiting
Approved:
December 18, 2025
Trial phase:
Phase 2
For more information:
ClinicalTrials.gov - NCT07420283
This is an external link. The information is not authorized by the Government of Canada.

Eligibility

Sex: ALL
Age
18 Years to 75 Years
Accepts healthy volunteers: No

Contacts and locations

Contact
Name
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Role
CONTACT
Phone:
1-317-615-4559
Name
Physicians interested in becoming principal investigators please contact
Role
CONTACT
Phone:
1-317-615-4559
Sponsor
ELI LILLY CANADA INC

Locations

CaRe Clinic
Calgary, T2N 4L7
RECRUITING
Role
CONTACT
Phone:
587-955-3401
Name
Sumantra Ghosh
Role
PRINCIPAL_INVESTIGATOR
Centre for Addiction and Mental Health (CAMH)
Toronto, M6J 1H4
RECRUITING
Name
Bernard Le Foll
Role
PRINCIPAL_INVESTIGATOR
Comprehensive Treatment Clinic
Toronto, M4J 1M3
RECRUITING
Name
Leonard Bienenstock
Role
PRINCIPAL_INVESTIGATOR
Kelowna Health and Memory Centre
Kelowna, V1Y 5A8
RECRUITING
Name
Eugene Okorie
Role
PRINCIPAL_INVESTIGATOR
Phone:
6135444900
Malton Medical Group
Mississauga, L4T 4J2
RECRUITING
Name
Leonard Bienenstock
Role
CONTACT
Phone:
905-677-4200
Name
Brian Zidel
Role
PRINCIPAL_INVESTIGATOR
Med Trust Research
Courtice, L1E 2J5
RECRUITING
Role
CONTACT
Phone:
905-728-7915
Name
Hamilton Jeyaraj
Role
PRINCIPAL_INVESTIGATOR
Providence Care
Kingston, K7L 4X3
RECRUITING
Name
Leonard Bienenstock
Role
CONTACT
Phone:
6135444900
Name
Roumen Milev
Role
PRINCIPAL_INVESTIGATOR
The Medical Arts Health Research Group
Kamloops, V2C 1K7
NOT_YET_RECRUITING
Name
Dustin Janz
Role
PRINCIPAL_INVESTIGATOR
Phone:
6135444900
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