A Study of Brenipatide in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

ClinicalTrials.gov ID: NCT07286175

Public ClinicalTrials.gov record NCT07286175. 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.

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ClinicalTrials.gov public records Last synced Sep 1, 2026, 1:41 PM EDT

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, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Bipolar Disorder (RENEW-Bipolar-1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT07286175
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 2
Lead sponsor: Eli Lilly and Company; Industry
Enrollment: 400 participants

Conditions and interventions

Conditions

Bipolar Disorder

Interventions

Brenipatide Drug
Placebo Drug

Drug

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: Nov 23, 2025
Primary completion: Oct 31, 2027
Completion: Oct 31, 2027
Last update posted: Aug 20, 2026

2025 – 2027

United States locations

U.S. sites: 20
U.S. states: 12
U.S. cities: 19

Facility	City	State	ZIP	Site status
ATP Clinical Research	Orange	California	92866	Recruiting
Yale University School of Medicine	New Haven	Connecticut	06519	Recruiting
AGA Clinical Trials	Hialeah	Florida	33012	Recruiting
Accel Research Sites - Maitland Clinical Research Unit	Maitland	Florida	32751	Recruiting
K2 Medical Research - Maitland	Maitland	Florida	32751	Recruiting
Floridian Clinical Research, LLC	Miami Lakes	Florida	33016-1518	Recruiting
CLA Research	Naples	Florida	34116	Recruiting
Charter Research - Orlando	Orlando	Florida	32803	Recruiting
Encore Medical Research - Weston	Weston	Florida	33331	Recruiting
Atlanta Center for Medical Research	Atlanta	Georgia	30331	Recruiting
Covenant Medical Center	Waterloo	Iowa	50702	Recruiting
CBH Health	Gaithersburg	Maryland	20877	Recruiting
Elixia MA	Springfield	Massachusetts	01103	Recruiting
Adams Clinical Watertown	Watertown	Massachusetts	02472	Recruiting
Penn Medicine: University of Pennsylvania Health System	Philadelphia	Pennsylvania	19104	Recruiting
Revival Research Institute, LLC	McKinney	Texas	75071	Recruiting
Pillar Clinical Research - Richardson	Richardson	Texas	75080	Recruiting
Alpine Research Organization	Clinton	Utah	84015	Recruiting
Re:Cognition Health	Fairfax	Virginia	22031	Recruiting
Northwest Clinical Research Center	Bellevue	Washington	98007	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 67 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT07286175, 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 Aug 20, 2026 · Synced Sep 1, 2026

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT07286175 live on ClinicalTrials.gov.

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