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NCT07412756 · ClinicalTrials.gov registry record · Phase 3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

A Phase 3 study of Depressive Disorder, Major, sponsored by Eli Lilly and Company.

Recruiting
Registry status
Phase 3
Development phase
1,000
Enrollment target
20
Study locations

NCT07412756 is a Phase 3 study of Depressive Disorder, Major that is actively recruiting participants, run by Eli Lilly and Company. The registered enrollment target is 1,000 participants, above the 223-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (348% higher). The trial reports 20 study locations across 11 states.

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The verdict

NCT07412756, a Phase 3 study of Depressive Disorder, Major, is actively recruiting participants, sponsored by Eli Lilly and Company.

RECRUITING
Registry status
Phase 3
Development phase
1,000 participants
Enrollment target
20
Study locations

Study Summary

This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a treatment period that will last a minimum of 12 months, and the follow up period that will last approximately 2 months. The duration of study participation may vary and may be shortened if depression symptoms worsen or if withdrawal from the study occurs for any reason.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Brenipatide

Study Locations (20)

Florida

  • Encore Medical Research - Hollywood
  • K2 Medical Research - Maitland - Maitland
  • Life Medical Research Group Corp - Miami Gardens
  • Floridian Clinical Research, LLC - Miami Lakes
  • CLA Research - Naples
  • Optimal Research Sites - Orange City
  • Charter Research - Orlando - Orlando
  • K2 Medical Research - Tampa - Tampa

California

  • Accellacare - Moorpark - Moorpark
  • ATP Clinical Research - Orange

Massachusetts

  • Adams Clinical Boston - Boston
  • Adams Clinical Watertown - Watertown

Connecticut

  • Yale University School of Medicine - New Haven

Georgia

  • CenExel iResearch, LLC - Decatur

Indiana

  • Indiana University Health Neuroscience Center - Indianapolis

Iowa

  • Cedar Valley Medical Specialists - Waterloo

Maryland

  • Pharmasite Research, Inc. - Baltimore

Trial Details

FieldValue
Enrollment Target 1,000 participants
Start Date 2026-02-09
Est. Completion 2028-02
Phase Phase 3

Sponsor

Eli Lilly and Company

1,341 total trials

What the Registry Record Tells You About NCT07412756

The ClinicalTrials.gov registry entry for NCT07412756 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 223-participant average among 52 other Depressive Disorder, Major trials with a reported enrollment target (348% 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 Depressive Disorder, Major appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT07412756 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Florida, California, Massachusetts.

Frequently Asked Questions

What is clinical trial NCT07412756 about?

NCT07412756 is a clinical study titled "A Study of Brenipatide in Adult Participants With Major Depressive Disorder". This study evaluates the safety and efficacy of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC in delaying the return of major depressive symptoms. The trial is divided into three periods as follows: a screening period that will last approximately 1 month, a ...

What is the current status of trial NCT07412756?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,000 participants. The study started on 2026-02-09. Estimated completion is 2028-02.

What conditions does trial NCT07412756 study?

This clinical trial studies the following conditions: Depressive Disorder, Major.

What interventions are being tested in trial NCT07412756?

The interventions under investigation include: Placebo (DRUG), Brenipatide (DRUG).

Who is sponsoring clinical trial NCT07412756?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07412756 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Indiana. 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.