A Study of Brenipatide in Participants With Opioid Use Disorder
Public ClinicalTrials.gov record NCT07420283. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07420283
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 465 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 12, 2026
- Primary completion
- Feb 29, 2028
- Completion
- Feb 29, 2028
- Last update posted
- Sep 3, 2026
2026 – 2028
United States locations
- U.S. sites
- 38
- U.S. states
- 19
- U.S. cities
- 33
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| NoesisPharma - Phoenix - East Shea Boulevard | Phoenix | Arizona | 85028 | Recruiting |
| Pillar Clinical Research- Little Rock | Little Rock | Arkansas | 72204 | Recruiting |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | Recruiting |
| Ark Clinical Research - Fountain Valley | Fountain Valley | California | 92708 | Recruiting |
| Center on Substance Use and Health (CSUH) | San Francisco | California | 94102 | Recruiting |
| UCSF Weill Institute for Neurosciences - Substance Use Disorders Clinic - Mission Bay | San Francisco | California | 94158 | Recruiting |
| Bradenton Research Center, Inc. | Bradenton | Florida | 34205 | Recruiting |
| K2 Medical Research - Daytona Beach | Daytona Beach | Florida | 32114 | Recruiting |
| NextPhase Research Florida - Hollywood | Hollywood | Florida | 33024 | Recruiting |
| Accel Research Sites - Lakeland Clinical Research Unit | Lakeland | Florida | 33803 | Recruiting |
| Life Arc Research Centers - Miami | Miami | Florida | 33126 | Recruiting |
| Advanced Research for Health Improvement, LLC | Naples | Florida | 34102 | Recruiting |
| Innovative Research Institute - Port Charlotte | Port Charlotte | Florida | 33952 | Recruiting |
| Better Years Ahead Medical Center | Tampa | Florida | 33614 | Recruiting |
| Neuroscience Research Institute - West Palm Beach | West Palm Beach | Florida | 33407 | Recruiting |
| Re:Cognition Health - Chicago | Chicago | Illinois | 60611 | Recruiting |
| Indiana University Health Neuroscience Center | Indianapolis | Indiana | 46202 | Recruiting |
| University of Kentucky Chandler Medical Center | Lexington | Kentucky | 40508 | Recruiting |
| Maryland Treatment Centers - Mountain Manor Treatment Center | Baltimore | Maryland | 21229 | Recruiting |
| Maryland Treatment Centers - Avery Road Treatment Center | Rockville | Maryland | 20853 | Recruiting |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | Recruiting |
| Adams Clinical Boston | Boston | Massachusetts | 02116 | Recruiting |
| Boston Medical Center | Boston | Massachusetts | 02118 | Not yet recruiting |
| Adams Clinical Watertown | Watertown | Massachusetts | 02472 | Recruiting |
| SKY Integrative Medical Center/SKYCRNG | Ridgeland | Mississippi | 39157 | Recruiting |
| Adams Clinical Harlem | New York | New York | 10029 | Recruiting |
| Adams Clinical Bronx | The Bronx | New York | 10461 | Recruiting |
| Ohio Clinical Trials | Columbus | Ohio | 43212 | Recruiting |
| Rivus Wellness and Research Institute | Oklahoma City | Oklahoma | 73112 | Not yet recruiting |
| Adams Clinical Philadelphia | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Penn Medicine: University of Pennsylvania Health System | Philadelphia | Pennsylvania | 19104 | Recruiting |
| Brown University School of Public Health | Providence | Rhode Island | 02903 | Recruiting |
| Avera Research Institute - Sioux Falls | Sioux Falls | South Dakota | 57108 | Recruiting |
| Adams Clinical Dallas | DeSoto | Texas | 75115 | Recruiting |
| Biopharma Informatic, LLC | Houston | Texas | 77043 | Recruiting |
| University of Virginia Health System | Charlottesville | Virginia | 22903 | Not yet recruiting |
| Carilion Clinic | Roanoke | Virginia | 24014 | Recruiting |
| University of Washington - Harborview Medical Center | Seattle | Washington | 98104 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 21 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07420283, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 3, 2026 · Synced Sep 7, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07420283 live on ClinicalTrials.gov.