Opioid Use Disorder study: Brenipatide vs Buprenorphine
Official title A Study of Brenipatide in Participants With Opioid Use Disorder
ClinicalTrials.gov ID: NCT07420283
What this study is testing
What is Brenipatide?
This is an investigational injectable medicine being studied to see if it helps people with opioid use disorder when used with buprenorphine.
Also referred to as LY3537031.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out if brenipatide is safe and works when used with the medication buprenorphine, with or without naloxone.
- Who it's for
- It is looking for adults who have opioid use disorder.
- What's involved
- Participants will receive either brenipatide or a placebo while also taking buprenorphine (and possibly naloxone). They will have regular visits and tests to monitor safety and effectiveness.
- Time commitment
- The study could last up to about 144 weeks for Part A or 116 weeks for Part B, with visits scheduled throughout that time.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- self-inject study intervention Note: Participants who are not able to perform the injections must have the assistance of a support person trained to...
- store and use the provided study intervention as directed
- maintain electronic or paper study diaries, as applicable, and
You likely can't join if
- Evidence of other substance use disorder(s) within 180 days of screening, except the following are permitted: any level tobacco 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...
- Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives...
- Had opioid overdose in past 6 months prior to screening
- schizophrenia or other psychotic disorder
See the full eligibility 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...
- 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
- 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...
- 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Fountain Valley, California, United States
- San Francisco, California, United States
- Bradenton, Florida, United States
- Daytona Beach, Florida, United States
- Hollywood, Florida, United States
- Lakeland, Florida, United States
- Miami, Florida, United States
- Naples, Florida, United States
- Port Charlotte, Florida, United States
- Tampa, Florida, United States
- West Palm Beach, Florida, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Baltimore, Maryland, United States
- Rockville, Maryland, United States
- Boston, Massachusetts, United States
- Watertown, Massachusetts, United States
+ 27 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Phoenix, Arizona, United States; Little Rock, Arkansas, United States; Fountain Valley, California, United States; San Francisco, California, United States; Bradenton, Florida, United States; Daytona Beach, Florida, United States and 41 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.