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NCT Number: NCT07412756

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 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.

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Key information

Conditions

Depressive Disorder, Major Behavior Behavioral Symptoms Depression Depressive Disorder Mental Disorders Mood Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

NeuroCentrix, Carlton, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brenipatide

Drug

Administered SC

Other names: LY3537031

Placebo

Drug

Administered SC

Primary outcomes

  1. 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

Secondary outcomes

  1. Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2

    Time frame: Baseline, Up to at Least 6 Months

  2. Change from Baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score

    Time frame: Baseline, Up to at Least 6 Months

  3. Change from Baseline in Sheehan Disability Scale (SDS) Global Functional Impairment Score

    Time frame: Baseline, Up to at Least 6 Months

  4. Change from Baseline in Patient Global Impression of Severity (PGI-S)

    Time frame: Baseline, Up to at Least 6 Months

  5. Change from Baseline in Generalized Anxiety Disorder (GAD) - 7 Total Score

    Time frame: Baseline, Up to at Least 6 Months

  6. Change from Baseline in Patient Rated Symptom and Disease Severity

    Time frame: Baseline, Up to at least 6 months

  7. Change from Baseline in Recovering Quality of Life - 20 Items (ReQoL-20) Total Score

    Time frame: Baseline, Up to at Least 6 Months

  8. Mean Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index (BMI) ≥25 kg/m2 and on an Atypical Antipsychotic

    Time frame: Baseline, Up to at Least 6 Months

  9. Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide

    Time frame: Predose Up to at Least 6 Months

  10. Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADA)

    Time frame: Baseline Up to at Least 6 Months

  11. Change from Baseline in Patient-Reported Outcomes Measurement Information Systems (PROMIS) Short Form

    Time frame: Baseline, Up to at Least 6 Months

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Delaying Time to Relapse Compared With Placebo in Adult Participants With Major Depressive Disorder (RENEW-MDD 1)

Acronym: RENEW-MDD-1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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