A Study of Brenipatide in Participants With Opioid Use Disorder

Conditions

• Opioid Use Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Brenipatide — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC
• Buprenorphine — DRUG
  Administered sublingual or buccal

Study Details

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.

Key Dates

Start date

Feb 13, 2026

Status verified

Jun 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

465 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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.
• Experimental: Part A: Brenipatide + Buprenorphine Dose 2
  Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
• Experimental: Part A: Brenipatide + Buprenorphine Dose 3
  Brenipatide administered SC + Buprenorphine administered sublingual or buccal.
• Placebo Comparator: Part A: Placebo + Buprenorphine
  Placebo administered SC + Buprenorphine administered sublingual or buccal.

Primary Outcome Measure

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 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  1-317-615-4559
  [email protected]

Locations (38)

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