RENEW-Op-1

RecruitingPhase 2

A Study of Brenipatide in Participants With Opioid Use Disorder

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)

Lead sponsor

Eli Lilly and Company

Asset

Brenipatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Estimated enrollment

465

Study population

Alcohol / substance use

Eligibility highlights

Primary endpoints

•Percentage of Weeks of Abstinence from Opioid Use•Achievement of ≥80% Weeks of Abstinence from Opioid Use

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07420283

Org study ID27348

Secondary IDJ2S-MC-GZMGEli Lilly and Company

Timeline

Milestones

Study start2026-02-13actual

Study first posted2026-02-19actual

Last update posted2026-11-04actual

Primary completion2028-03estimated (month precision)

Study completion2028-03estimated (month precision)

Assets

Investigational agents

Brenipatide

Who this study enrolls

Alcohol / substance use

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (16)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Other (unclassified)

Weight & body composition

Safety / tolerability / PK

Cardiometabolic biomarkers

Patient-reported / QoL

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 24

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Blood Pressure

Time frame:Baseline, Week 24

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change from Baseline on Quality of Life Outcome on Short Inventory of Problems - Revised (SIP-R)

Time frame:Baseline, Week 24

change from baseline, improvement

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

Pharmacokinetics (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

Time frame:Baseline up to Week 24

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Treatment-Emergent Anti-drug Antibodies

Time frame:Baseline up to Week 24

event count, event

Other clinical outcomes

5 endpoints

Primary/protocol endpoint

Percentage of Weeks of Abstinence from Opioid Use Defined by Both Negative Urine Drug Screen (UDS) and no Self-Report of Opioid use Based on Timeline Followback (TLFB)

Time frame:Week 13 up to Week 24

descriptive

Primary/protocol endpoint

Achievement of ≥80% Weeks of Abstinence from Opioid Use Defined by Both Negative UDS and no Self-Report of Opioid Use Based on TLFB

Time frame:Week 13 up to Week 24

threshold achievement, improvement

Secondary/protocol endpoint

Gated Secondary Outcome: Adherence to Buprenorphine as Demonstrated by Self-Report Buprenorphine, with or Without Naloxone (BUP±NX) and not Contradicted by Negative UDS (BUP)

Time frame:Week 13 up to Week 24

descriptive

Secondary/protocol endpoint

Achievement of 100% Weeks of Abstinence from Opioid Use Defined by Both Negative UDS and no Self-Report of Opioid Use Based on TLFB

Time frame:Week 13 up to Week 24

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline on Incidence of Healthcare Provider Visits Using Lilly-developed Health Care Resource Utilization (HCRU) scale

Time frame:Baseline, Week 24

change from baseline, improvement

Other (unclassified)

5 endpoints

Secondary/protocol endpoint/low confidence

Occurrence of Opioid Overdose(s) (Nonfatal or Fatal)

Time frame:Week 1 up to Week 24

descriptive

Secondary/protocol endpoint/low confidence

Change in Buprenorphine Dose From Baseline

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Modified Penn Craving Scale (PCS)

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline on Work and Social Adjustment Scale (WSAS)

Time frame:Baseline, Week 24

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Achievement of >1 Level of Reduction of Diagnosis Severity Category or no Longer Have OUD Diagnosis per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

Time frame:Baseline, Week 24

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.