臨床研究等提出・公開システム

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) (J2S-MC-GZMH)

A Study of Brenipatide in Adult Participants With Major Depressive Disorder (J2S-MC-GZMH)

Takeshi Masaki

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

Mar. 13, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- 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
*D23 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

- 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

Both

Depressive Disorder, Major

DRUG: Brenipatide(Other Name: LY3537031)
Administered SC
DRUG: Placebo
Administered SC

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

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]

+81-248-42-2121

Oct. 14, 2025

Yes

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

United States/Australia/Brazil/Canada/China/Germany/Greece/Mexico/Poland/Puerto Rico/South Korea/Spain/Taiwan/United Kingdom