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Clinical Trials in the UK / NCT07420283
Recruiting Phase 2

A Study of Brenipatide in Participants With Opioid Use Disorder

NCT07420283 · tracked via the Priya Life Science UK tracker
Sponsor
Eli Lilly and Company
Phase
Phase 2
Started
2026-02-13
Last updated
2026-09-04

Condition(s) studied

Opioid Use Disorder

Investigational drug(s) / intervention(s)

BrenipatidePlaceboBuprenorphine

Brenipatide: Administered SC

Placebo: Administered SC

Buprenorphine: Administered sublingual or buccal

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
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

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
NoesisPharma - Phoenix - East Shea Boulevard Phoenix Arizona Recruiting
Pillar Clinical Research- Little Rock Little Rock Arkansas Recruiting
Woodland International Research Group Little Rock Arkansas Recruiting
Ark Clinical Research - Fountain Valley Fountain Valley California Recruiting
Center on Substance Use and Health (CSUH) San Francisco California Recruiting
UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay San Francisco California Recruiting
Bradenton Research Center, Inc. Bradenton Florida Recruiting
K2 Medical Research - Daytona Beach Daytona Beach Florida Recruiting
NextPhase Research Florida - Hollywood Hollywood Florida Recruiting
Accel Research Sites - Lakeland Clinical Research Unit Lakeland Florida Recruiting
Life Arc Research Centers - Miami Miami Florida Recruiting
Advanced Research for Health Improvement, LLC Naples Florida Recruiting
Innovative Research Institute - Port Charlotte Port Charlotte Florida Recruiting
Better Years Ahead Medical Center Tampa Florida Recruiting
Neuroscience Research Institute - West Palm Beach West Palm Beach Florida Recruiting
Re:Cognition Health - Chicago Chicago Illinois Recruiting
Indiana University Health Neuroscience Center Indianapolis Indiana Recruiting
University of Kentucky Chandler Medical Center Lexington Kentucky Recruiting
Maryland Treatment Centers - Mountain Manor Treatment Center Baltimore Maryland Recruiting
Maryland Treatment Centers - Avery Road Treatment Center Rockville Maryland Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
Adams Clinical Boston Boston Massachusetts Recruiting
Boston Medical Center Boston Massachusetts Not Yet Recruiting
Adams Clinical Watertown Watertown Massachusetts Recruiting
SKY Integrative Medical Center/SKYCRNG Ridgeland Mississippi Recruiting
Adams Clinical Harlem New York New York Recruiting
Adams Clinical Bronx The Bronx New York Recruiting
Ohio Clinical Trials Columbus Ohio Recruiting
Rivus Wellness and Research Institute Oklahoma City Oklahoma Not Yet Recruiting
Adams Clinical Philadelphia Philadelphia Pennsylvania Recruiting
Penn Medicine: University of Pennsylvania Health System Philadelphia Pennsylvania Recruiting
Brown University School of Public Health Providence Rhode Island Recruiting
Avera Research Institute - Sioux Falls Sioux Falls South Dakota Recruiting
Adams Clinical Dallas DeSoto Texas Recruiting
Biopharma Informatic, LLC Houston Texas Recruiting
University of Virginia Health System Charlottesville Virginia Not Yet Recruiting
Carilion Clinic Roanoke Virginia Recruiting
University of Washington - Harborview Medical Center Seattle Washington Recruiting
CaRe Clinic Calgary Canada Recruiting
Med Trust Research Courtice Canada Recruiting

+ 19 more sites — see the full list on the official registry below.

More Eli Lilly and Company trials in the UK

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07420283 on ClinicalTrials.gov ↗ ← All trials in the UK