A Phase 2 interventional study of Brenipatide and Placebo in Opioid Use Disorder, sponsored by Eli Lilly and Company. Recruiting at 68 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment
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Among 1,222 studies in Opioid-Related Disorders with a site in United States — 245 open to participants now, 315 under way, 19 of them phase 3. Opioid-Related Disorders · United States.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, this one is the 100th largest by planned enrollment of the 1,097 interventional ones that give a count, is one of 83 that started in 2026, is one of 190 in phase 2, reaches primary completion later than 224 of the 314 other live ones, and was the 1,169th registered.
1,473 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.
Browse Opioid-Related Disorders studies →245 of the 1,222 studies in Opioid-Related Disorders with a site in United States are open now. Recruiting first, the newest first:
Washington State University · Sites in United States
Ages 18+
University of Massachusetts, Worcester · Sites in United States
Ages 18+ · Healthy volunteers
Baylor College of Medicine · Sites in United States
Ages 18–64
Yale University · Sites in United States
Ages 25–65 · Healthy volunteers
Adneuris Therapeutics, Inc. · Sites in United States
Ages 18–65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 209 Opioid-Related Disorders studies recruiting now, 122 (58%) set no upper age limit and 73 (35%) stop at 75 or younger; 14 take children under 18; 52 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
1,222 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 162 · Phase 2 245 · Phase 3 100 · Phase 4 79
First in 1988; this study’s year is marked. 83 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 465 is above the median of 63 across 1,167 interventional studies indexed under Opioid-Related Disorders.
Median enrollment 56 across the 1,097 interventional studies, 85 across the 122 observational. Of the 834 that completed or were terminated, 331 (40%) have results posted.
This tab as a report to print or save as PDF → With an account.
132 of 1,222 have an industry lead sponsor. The 10 most frequent:
Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 151 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 358 (67%) have results posted.
Eli Lilly and Company has 1 study filed under Opioid-Related Disorders — fewer than ten, so there is no comparison to draw.
128 of the studies in Opioid-Related Disorders with a site in United States that are under way reach primary completion within a year, 9 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05011266Phase 3New York State Psychiatric InstituteEfficacy of Buprenorphine and XR-Naltrexone Combination for Relapse Prevention in Opioid Use Disorder | 2027-01-01 |
| NCT05834478Phase 3Emory UniversityNon-invasive Vagal Nerve Stimulation in Opioid Use Disorders UH3 | 2027-02 |
| NCT05033028Phase 3NYU Langone HealthSmartphones for Opiate Addiction Recovery | 2027-06-01 |
| NCT05459402Phase 3University of Maryland, BaltimoreDivided or Single Exposure (DOSE) Study | 2027-06-01 |
| NCT05766631Phase 3Friends Research Institute, Inc.Treating Polysubstance Use Using a Novel Digital Technology | 2027-06-30 |
Add all 128 to your calendar (.ics) → With an account.
Among the 1,222 studies in Opioid-Related Disorders with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
The study consists of 2 parts, each with its own participant cohort
Participants will be enrolled in only one part of the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria:
Note: any level of caffeine use is allowed
Have a lifetime history or current diagnosis of the following:
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 · Drug: Buprenorphine
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
Drug: Brenipatide · Drug: Buprenorphine
Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
Drug: Brenipatide · Drug: Buprenorphine
Placebo administered SC + Buprenorphine administered sublingual or buccal.
Drug: Placebo · Drug: Buprenorphine
Administered SC
Also known as: LY3537031
Administered SC
Administered sublingual or buccal
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
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
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
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
Occurrence of Opioid Overdose(s) (Nonfatal or Fatal)
Time frame: Week 1 up to Week 24
Change in Buprenorphine Dose From Baseline
Time frame: Baseline, Week 24
Change from Baseline in Modified Penn Craving Scale (PCS)
Time frame: Baseline, Week 24
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 on Work and Social Adjustment Scale (WSAS)
Time frame: Baseline, Week 24
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
Change from Baseline on Quality of Life Outcome on Short Inventory of Problems - Revised (SIP-R)
Time frame: Baseline, Week 24
Change from Baseline in Body Weight
Time frame: Baseline, Week 24
Change from Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 24
Change from Baseline in Blood Pressure
Time frame: Baseline, Week 24
Pharmacokinetics (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide
Time frame: Baseline up to Week 24
Number of Participants with Treatment-Emergent Anti-drug Antibodies
Time frame: Baseline up to Week 24
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
Data sharing details ↗ · vivli.org
Started Feb 2026 (actual). Primary completion is estimated for Mar 2028, 25 months after the start.
Of 68 phase 2 interventional studies under Opioid-Related Disorders, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 55. This study's planned 25 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Studies of the drug tested here: Brenipatide