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A Study of Brenipatide in Participants With Opioid Use Disorder

ConditionOpioid Use Disorder
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brenipatide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

  • Buprenorphine

    Drug

    Administered sublingual or buccal

Treatment groups

465 Participants
are divided into 4 treatment groups
Group A: Part A and Part B: Brenipatide + Buprenorphine Dose 1Experimental treatment 2 interventions
Group B: Part A: Brenipatide + Buprenorphine Dose 2Experimental treatment 2 interventions
Group C: Part A: Brenipatide + Buprenorphine Dose 3Experimental treatment 2 interventions
Group D: Part A: Placebo + BuprenorphinePlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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

Time frame
Week 1 up to Week 24
4

Change in Buprenorphine Dose From Baseline

Time frame
Baseline, Week 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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