A Study of Brenipatide in Participants With Opioid Use Disorder

Purpose

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.

Condition

  • Opioid Use Disorder

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have a current mild, moderate or severe opioid use disorder (OUD) - Are reliable and willing to make themselves available for the duration of the study (for example, are not incarcerated, not homeless) and attend required study visits, and are willing and able to follow study procedures as required, such as - self-inject study intervention Note: Participants who are not able to perform the injections must have the assistance of a support person trained to administer the study intervention - store and use the provided study intervention as directed - maintain electronic or paper study diaries, as applicable, and - complete the required questionnaires - Are intermittently using non-legal, non-prescribed opioids - Are taking buprenorphine for treatment on OUD

Exclusion Criteria

  • Evidence of other substance use disorder(s) within 180 days of screening, except the following are permitted: any level tobacco use disorder, mild-to-moderate alcohol or mild-to-moderate cannabis use disorder Note: any level of caffeine use is allowed - Are actively suicidal or deemed a significant risk for suicide - Have a history of advanced liver disease (including advanced liver fibrosis or cirrhosis or alcohol-associated hepatitis based on either prior liver histology or imaging studies, such as transient elastography, ultrasound, computed tomography (CT) and magnetic resonance imaging (MRI), or Enhanced Liver Fibrosis score - Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening - Had opioid overdose in past 6 months prior to screening - Have a lifetime history or current diagnosis of the following: - schizophrenia or other psychotic disorder - bipolar disorder - borderline personality disorder - any eating disorder - Have type 1 diabetes mellitus, or a history of ketoacidosis, or hyperosmolar state, or coma

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part A and Part B: Brenipatide + Buprenorphine Dose 1 		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.
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
  • Drug: Buprenorphine
    Administered sublingual or buccal
Experimental
Part A: Brenipatide + Buprenorphine Dose 2 		Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
  • Drug: Buprenorphine
    Administered sublingual or buccal
Experimental
Part A: Brenipatide + Buprenorphine Dose 3 		Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
  • Drug: Brenipatide
    Administered SC
    Other names:
    • LY3537031
  • Drug: Buprenorphine
    Administered sublingual or buccal
Placebo Comparator
Part A: Placebo + Buprenorphine 		Placebo administered SC + Buprenorphine administered sublingual or buccal.
  • Drug: Placebo
    Administered SC
  • Drug: Buprenorphine
    Administered sublingual or buccal

Recruiting Locations

NoesisPharma - Phoenix - East Shea Boulevard
Phoenix, Arizona 85028

Woodland International Research Group
Little Rock, Arkansas 72211
Contact:
501-221-8681

Ark Clinical Research - Fountain Valley
Fountain Valley, California 92708
Contact:
714-988-2021

Center on Substance Use and Health (CSUH)
San Francisco, California 94102

UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay
San Francisco, California 94158

Bradenton Research Center, Inc.
Bradenton, Florida 34205
Contact:
941-708-0005

K2 Medical Research - Daytona Beach
Daytona Beach, Florida 32114

NextPhase Research Florida - Hollywood
Hollywood, Florida 33024

Accel Research Sites - Lakeland Clinical Research Unit
Lakeland, Florida 33803
Contact:
863-940-2087

Life Arc Research Centers - Miami
Miami, Florida 33126
Contact:
305-874-7401

Advanced Research for Health Improvement, LLC
Naples, Florida 34102
Contact:
239-230-2021

Innovative Research Institute - Port Charlotte
Port Charlotte, Florida 33952
Contact:
941-505-2100

Better Years Ahead Medical Center
Tampa, Florida 33614
Contact:
813-709-8299

Neuroscience Research Institute - West Palm Beach
West Palm Beach, Florida 33407

Re:Cognition Health - Chicago
Chicago, Illinois 60611

Indiana University Health Neuroscience Center
Indianapolis, Indiana 46202

University of Kentucky Chandler Medical Center
Lexington, Kentucky 40508

Maryland Treatment Centers - Mountain Manor Treatment Center
Baltimore, Maryland 21229

Maryland Treatment Centers - Avery Road Treatment Center
Rockville, Maryland 20853

Brigham and Women's Hospital
Boston, Massachusetts 02115

Adams Clinical Boston
Boston, Massachusetts 02116

Adams Clinical Watertown
Watertown, Massachusetts 02472
Contact:
617-744-8542

SKY Integrative Medical Center/SKYCRNG
Ridgeland, Mississippi 39157
Contact:
601-567-1321

Adams Clinical Harlem
New York, New York 10029
Contact:
917-423-67697

Adams Clinical Bronx
The Bronx, New York 10461

Ohio Clinical Trials
Columbus, Ohio 43212
Contact:
380-210-2424

Adams Clinical Philadelphia
Philadelphia, Pennsylvania 19104

Brown University School of Public Health
Providence, Rhode Island 02903

Avera Research Institute - Sioux Falls
Sioux Falls, South Dakota 57108
Contact:
605-504-3154

Adams Clinical Dallas
DeSoto, Texas 75115

Biopharma Informatic, LLC
Houston, Texas 77043
Contact:
281-944-3610

Carilion Clinic
Roanoke, Virginia 24014
Contact:
540-981-8025

University of Washington - Harborview Medical Center
Seattle, Washington 98104

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

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.