A Study of Brenipatide in Adult Participants With Major Depressive Disorder

Conditions

• Depressive Disorder, Major

Eligibility Criteria

Sex

ALL

Age

18 Years - 75 Years

Healthy Volunteers

Not accepted

Interventions

• Brenipatide — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

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.

Key Dates

Start date

Feb 9, 2026

Status verified

Mar 2026

Primary completion

Feb 29, 2028

Completion

Feb 29, 2028

Study Design

Enrollment

1,000 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Brenipatide Dose 1
  Brenipatide administered subcutaneously (SC) + standard of care (SoC).
• Experimental: Brenipatide Dose 2
  Brenipatide administered SC + SoC
• Experimental: Brenipatide Dose 3
  Brenipatide administered SC + SoC
• Placebo Comparator: Placebo
  Placebo administered SC + SoC.

Primary Outcome Measure

Time to Relapse Defined as the Number of Days from Randomization to Date on Which the Participant Meets Any Relapse Criterion of Major Depressive Disorder (MDD) [ Time Frame: From Randomization in Double-Blind Adjunctive Treatment to First Relapse For at Least 12 Months ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (32)

Find similar trials in Moorpark, CA

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