Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT07420283

A Study of Brenipatide in Participants With Opioid Use Disorder

Led by Eli Lilly and Company · Updated on 2026-04-23

465

Participants Needed

57

Research Sites

106 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

A Study of Brenipatide in Participants With Opioid Use Disorder

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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 all required visits
  • Are willing and able to follow study procedures, including self-injection or assisted injection of study drug
  • Are willing to store and use study medication as directed
  • Are willing to maintain study diaries and complete questionnaires
  • Are intermittently using non-legal, non-prescribed opioids
  • Are currently taking buprenorphine for OUD treatment
Not Eligible

You will not qualify if you...

  • Have other substance use disorders within 180 days of screening, except tobacco use disorder and mild-to-moderate alcohol or cannabis use disorder
  • Are actively suicidal or at significant risk for suicide
  • Have advanced liver disease or related serious liver conditions
  • Participated in another clinical study with active treatment within 90 days or 5 half-lives before screening
  • Had an opioid overdose in the past 6 months prior to screening
  • Have a lifetime or current diagnosis of schizophrenia, psychotic disorder, bipolar disorder, borderline personality disorder, or any 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

1
2
3
+1

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

Not Yet 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

Not Yet 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

Actively Recruiting

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

Not Yet 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

Suspended

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

Not Yet 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

Not Yet Recruiting

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

Not Yet 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

Not Yet 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

Not Yet Recruiting

54

Salford Royal Hospital

Salford, United Kingdom, M6 8HD

Not Yet Recruiting

55

Bioluminux - Southampton

Southampton, United Kingdom, SO15 2AQ

Not Yet Recruiting

56

Old Bank House Hillingdon Drug & Alcohol

Uxbridge, United Kingdom, UB8 1JP

Not Yet Recruiting

57

Bioluminux - Wolverhampton

Wolverhampton, United Kingdom, WV9 5HB

Not Yet Recruiting

Loading map...

Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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

A Study of Brenipatide in Participants With Opioid Use Disorder | DecenTrialz