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RECRUITING Phase 3

A Study of Brenipatide in Adult Participants With Major Depressive Disorder

NCT07412756 · View on ClinicalTrials.gov ↗

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

704 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07412756

The ClinicalTrials.gov registry entry for NCT07412756 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1,000 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eli Lilly and Company, which has 704 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07412756 reports 20 study locations spanning 11 distinct geographic areas — top geographies include Florida, California, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT07412756?

The interventions under investigation include: Placebo (DRUG), Brenipatide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07412756?

This trial is sponsored by Eli Lilly and Company, which has 704 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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