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A Phase 2 Multicenter, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment With Brenipatide in Adult Participants With Schizophrenia (RENEW-Scz-1) (J2S-MC-GZMK)

A Study of Brenipatide in Adult Participants With Schizophrenia (J2S-MC-GZMK)

Masaki Takeshi

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

Pending

Feb. 27, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

- Meet the diagnostic criteria of schizophrenia
- Are on a stable standard of care medication regimen for schizophrenia
- If the duration of illness is >6 years, participant has experienced at least one relapse of schizophrenia in last 3 years
- Have at least 1 reliable study partner (for example, a family member, social worker, caseworker, residential facility staff, or nurse)
- 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 study intervention as directed,
* maintain electronic or paper study diaries, as applicable, and
* complete the required questionnaires

- Have lifetime history of bipolar disorder, borderline personality disorder, or any eating disorder
- Evidence of moderate or severe substance or alcohol use disorder within 180 days of screening
- Have type 1 diabetes, or history of ketoacidosis or hyperosmolar state or coma
- Are actively suicidal or deemed to be a significant risk for suicide
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

Both

Schizophrenia

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

(Study Arms)
Experimental: Brenipatide
Brenipatide administered subcutaneously (SC) + SoC.
Interventions:
Drug: Brenipatide
Placebo Comparator: Placebo
Placebo administered SC + SoC.
Interventions:
Drug: Placebo

Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index >=25.0 Kilograms per Meter Squared (kg/m2) [Time Frame: Baseline, Week 52]

+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/Argentina/Brazil/China/India/Taiwan