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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 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.

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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

Bipolar Disorder

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

FieldValue
Enrollment Target 400 participants
Start Date 2025-11-24
Est. Completion 2027-11
Phase Phase 2

Sponsor

Eli Lilly and Company

1,341 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07286175

The ClinicalTrials.gov registry entry for NCT07286175 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 400 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (21% higher). The listed sponsor is Eli Lilly and Company, which has 1,341 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.