A Study of Brenipatide in Adult Participants With Major Depressive Disorder (RENEW-MDD-1)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Depressive Disorder, Major

Treatments: Drug: Placebo; Drug: Brenipatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07412756

2025-522308-25-00 (EU Trial (CTIS) Number)

J2S-MC-GZMH (Other Identifier)

27363

Details and patient eligibility

About

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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Meet the diagnostic criteria for major depressive disorder

• Are on a stable standard of care medication for major depressive disorder

• Are reliable and willing to make themselves available for the duration of the study and attend required study visits, and are willing and able to follow study procedures as required, such as

  • self-inject study intervention
  • store and use the provided blinded study intervention, as directed
  • maintain electronic and paper study diaries, as applicable, and
  • complete the required questionnaires

Exclusion criteria

• Have a lifetime history or current diagnosis of the following:

  • schizophrenia or other psychotic disorder
  • bipolar disorder
  • borderline personality disorder, or
  • any eating disorder.

• Have type 1 diabetes mellitus, or a history of

  • ketoacidosis, or
  • hyperosmolar state or coma.

• Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening

• Are actively suicidal or deemed a significant risk for suicide

• Have participated in a clinical study and received active treatment, or unknown if they received active treatment, within 90 days or 5 half-lives (whichever is longer) before screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 4 patient groups, including a placebo group

Brenipatide Dose 1

Experimental group

Description:

Brenipatide administered subcutaneously (SC) + standard of care (SoC).

Treatment:

Drug: Brenipatide

Brenipatide Dose 2

Experimental group

Description:

Brenipatide administered SC + SoC

Treatment:

Drug: Brenipatide

Brenipatide Dose 3

Experimental group

Description:

Brenipatide administered SC + SoC

Treatment:

Drug: Brenipatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC + SoC.

Treatment:

Drug: Placebo