Actively Recruiting
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study With Open-label Cohort to Evaluate Brenipatide as Adjunctive Treatment to Buprenorphine in Early Recovery of Opioid Use Disorder
Led by Eli Lilly and Company · Updated on 2026-06-03
465
Participants Needed
57
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating brenipatide as an additional treatment to buprenorphine, with or without naloxone, for people with opioid use disorder (OUD). This Phase 2 study aims to compare the safety and effectiveness of brenipatide against a placebo. The study includes two parts: Part A involves a double-blind treatment phase followed by an open-label extension, while Part B consists of open-label treatment only, with participants joining one part only. In Part A, participants receive subcutaneous injections of either brenipatide or placebo along with buprenorphine administered under the tongue or in the cheek. Part B participants receive open-label brenipatide injections plus buprenorphine. Dosing includes different levels of brenipatide combined with buprenorphine, and the study treatment is self-injected, with assistance provided if needed. Participants will be involved in the study for up to about 144 weeks in Part A and 116 weeks in Part B, depending on enrollment timing. The study includes regular visits for monitoring opioid abstinence through urine drug tests and self-reports, adherence to buprenorphine, assessment of craving, quality of life, and safety. Researchers will also track any opioid overdoses, changes in body measurements, healthcare visits, and potential immune responses to the drug throughout the study.
CONDITIONS
Brief Title
A Study of Brenipatide in Participants With Opioid Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a current mild, moderate or severe opioid use disorder (OUD)
- Are reliable and willing to be available for the study duration and attend required visits
- Are willing and able to follow study procedures, including self-injection or having trained assistance
- Are intermittently using non-legal, non-prescribed opioids
- Are taking buprenorphine for OUD treatment
You will not qualify if you...
- Have other substance use disorders within 180 days of screening except tobacco, mild-to-moderate alcohol, or mild-to-moderate cannabis use disorder
- Are actively suicidal or a significant suicide risk
- Have advanced liver disease or related conditions
- Participated in a clinical study with active treatment within 90 days before screening
- Had opioid overdose in past 6 months
- Have a history or current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, or eating disorder
- Have type 1 diabetes mellitus or history of ketoacidosis, hyperosmolar state, or coma
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive Brenipatide or placebo via subcutaneous injection along with buprenorphine administered sublingually or buccally as part of their opioid use disorder treatment.
Regular visits during treatment period
Trial Site Locations
Total: 57 locations
1
NoesisPharma - Phoenix - East Shea Boulevard
Phoenix, Arizona, United States, 85028
Actively Recruiting
2
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States, 72204
Not Yet Recruiting
3
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
4
Ark Clinical Research - Fountain Valley
Fountain Valley, California, United States, 92708
Actively Recruiting
5
Center on Substance Use and Health (CSUH)
San Francisco, California, United States, 94102
Actively Recruiting
6
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
7
Bradenton Research Center, Inc.
Bradenton, Florida, United States, 34205
Actively Recruiting
8
K2 Medical Research - Daytona Beach
Daytona Beach, Florida, United States, 32114
Actively Recruiting
9
NextPhase Research Florida - Hollywood
Hollywood, Florida, United States, 33024
Actively Recruiting
10
Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida, United States, 33803
Actively Recruiting
11
Life Arc Research Centers - Miami
Miami, Florida, United States, 33126
Actively Recruiting
12
Advanced Research for Health Improvement, LLC
Naples, Florida, United States, 34102
Actively Recruiting
13
Innovative Research Institute - Port Charlotte
Port Charlotte, Florida, United States, 33952
Actively Recruiting
14
Better Years Ahead Medical Center
Tampa, Florida, United States, 33614
Actively Recruiting
15
Neuroscience Research Institute - West Palm Beach
West Palm Beach, Florida, United States, 33407
Actively Recruiting
16
Re:Cognition Health - Chicago
Chicago, Illinois, United States, 60611
Suspended
17
Indiana University Health Neuroscience Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
18
University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40508
Actively Recruiting
19
Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland, United States, 21229
Actively Recruiting
20
Maryland Treatment Centers - Avery Road Treatment Center
Rockville, Maryland, United States, 20853
Not Yet Recruiting
21
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
22
Adams Clinical Boston
Boston, Massachusetts, United States, 02116
Actively Recruiting
23
Boston Medical Center
Boston, Massachusetts, United States, 02118
Not Yet Recruiting
24
Adams Clinical Watertown
Watertown, Massachusetts, United States, 02472
Actively Recruiting
25
SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi, United States, 39157
Actively Recruiting
26
Adams Clinical Harlem
New York, New York, United States, 10029
Actively Recruiting
27
Adams Clinical Bronx
The Bronx, New York, United States, 10461
Actively Recruiting
28
Ohio Clinical Trials
Columbus, Ohio, United States, 43212
Actively Recruiting
29
Rivus Wellness and Research Institute
Oklahoma City, Oklahoma, United States, 73112
Not Yet Recruiting
30
Adams Clinical Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
31
Penn Medicine: University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
32
Brown University School of Public Health
Providence, Rhode Island, United States, 02903
Actively Recruiting
33
Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota, United States, 57108
Actively Recruiting
34
Adams Clinical Dallas
DeSoto, Texas, United States, 75115
Actively Recruiting
35
Biopharma Informatic, LLC
Houston, Texas, United States, 77043
Actively Recruiting
36
University of Virginia Health System
Charlottesville, Virginia, United States, 22903
Not Yet Recruiting
37
Carilion Clinic
Roanoke, Virginia, United States, 24014
Not Yet Recruiting
38
University of Washington - Harborview Medical Center
Seattle, Washington, United States, 98104
Actively Recruiting
39
CaRe Clinic
Calgary, Canada, T2N 4L7
Not Yet Recruiting
40
Med Trust Research
Courtice, Canada, L1E 2J5
Actively Recruiting
41
Kelowna Health and Memory Centre
Kelowna, Canada, V1Y 5A8
Actively Recruiting
42
Providence Care
Kingston, Canada, K7L 4X3
Not Yet Recruiting
43
Malton Medical Group
Mississauga, Canada, L4T 4J2
Actively Recruiting
44
Comprehensive Treatment Clinic
Toronto, Canada, M4J 1M3
Actively Recruiting
45
Centre for Addiction and Mental Health (CAMH)
Toronto, Canada, M6J 1H4
Not Yet Recruiting
46
Gordon and Leslie Diamond Health Care Centre
Vancouver, Canada, V5Z 1M9
Suspended
47
Research Works San Juan
Guaynabo, Puerto Rico, 00966
Not Yet Recruiting
48
Surrey and Borders Partnership NHS Foundation Trust
Chertsey, United Kingdom, KT16 9AU
Actively Recruiting
49
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Not Yet Recruiting
50
St Pancras Clinical Research
London, United Kingdom, EC2Y 8EA
Not Yet Recruiting
51
Bioluminux - London
London, United Kingdom, SE6 4LF
Actively Recruiting
52
Lambeth Drug and Alcohol Treatment Consortium
London, United Kingdom, SW9 8DG
Not Yet Recruiting
53
Bioluminux Clinical Research - Milton Keynes
Milton Keynes, United Kingdom, MK15 0DU
Actively Recruiting
54
Salford Royal Hospital
Salford, United Kingdom, M6 8HD
Not Yet Recruiting
55
Bioluminux - Southampton
Southampton, United Kingdom, SO15 2AQ
Actively Recruiting
56
Old Bank House Hillingdon Drug & Alcohol
Uxbridge, United Kingdom, UB8 1JP
Not Yet Recruiting
57
Bioluminux - Wolverhampton
Wolverhampton, United Kingdom, WV9 5HB
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here