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NCT07286175 · ClinicalTrials.gov registry record · Phase 2
A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)
A Phase 2 study of Bipolar Disorder, sponsored by Eli Lilly and Company.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 400
- Enrollment target
- 20
- Study locations
NCT07286175: Recruiting Phase 2 study of Bipolar Disorder, sponsored by Eli Lilly and Company.
NCT07286175 is a Phase 2 study of Bipolar Disorder that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 400 participants, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (21% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07286175, a Phase 2 study of Bipolar Disorder, is actively recruiting participants, sponsored by Eli Lilly and Company.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 400 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last approximately 1 month, treatment period that will last a minimum of 6 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if bipolar symptoms worsen or if withdrawal from the study occurs for any reason.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Brenipatide
Study Locations (20)
Florida
- AGA Clinical Trials - Hialeah
- Accel Research Sites - Maitland Clinical Research Unit - Maitland
- K2 Medical Research - Maitland - Maitland
- Floridian Clinical Research, LLC - Miami Lakes
- CLA Research - Naples
- Charter Research - Orlando - Orlando
- Encore Medical Research - Weston - Weston
Massachusetts
- Elixia MA - Springfield
- Adams Clinical Watertown - Watertown
Texas
- Revival Research Institute, LLC - McKinney
- Pillar Clinical Research - Richardson - Richardson
California
- ATP Clinical Research - Orange
Connecticut
- Yale University School of Medicine - New Haven
Georgia
- Atlanta Center for Medical Research - Atlanta
Iowa
- Covenant Medical Center - Waterloo
Maryland
- CBH Health - Gaithersburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 400 participants |
| Start Date | 2025-11-24 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
What NCT07286175 shows while recruiting
NCT07286175 is an interventional study that assigns participants to a tested intervention. The registered 400 participants enrollment target is mid-sized for trials with a published cap, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (21% higher).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT07286175 names 20 study sites across 12 states, led by Florida, Massachusetts, Texas.
Frequently Asked Questions
What is clinical trial NCT07286175 about?
NCT07286175 is a clinical study titled "A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)". The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC), compared with placebo plus SoC in delaying the worsening of bipolar disorder symptoms. The trial is divided into three periods as follows: Screening period that will last app...
What is the current status of trial NCT07286175?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 400 participants. The study started on 2025-11-24. Estimated completion is 2027-11.
What conditions does trial NCT07286175 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT07286175?
The interventions under investigation include: Placebo (DRUG), Brenipatide (DRUG).
Who is sponsoring clinical trial NCT07286175?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07286175 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Georgia, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07286175's enrollment target sits among peer trials
400 17th of 162 higher than 145 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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