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NCT Number: NCT07410507

A Study of Brenipatide in Adult Participants With Schizophrenia

The purpose of this study is to assess the efficacy and safety of brenipatide when administered with standard of care (SoC) compared to placebo plus SoC for treatment of schizophrenia.

The trial is divided into three periods as follows: Screening period will last approximately 1 month, treatment period will last a maximum of 12 months, and the follow up period will last approximately 2 months. The length of time of your study participation may last up to approximately 15 months.

Recruiting

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centro Neurobiológico y de Estrés Traumático (CENydET), Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Brenipatide

Drug

Administered SC

Other names: LY3537031

Placebo

Drug

Administered SC

Primary outcomes

  1. 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

Secondary outcomes

  1. Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36

    Time frame: Baseline, Week 36

  2. Time to Relapse

    Time frame: Randomization up to Week 52

    Time to relapse defined as days from randomization to the dates on which the participant meets any relapse criteria.

  3. Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH)

    Time frame: Baseline, Week 52

  4. Change from Baseline in Patient Global Impression - Severity

    Time frame: Baseline, Week 52

  5. Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score

    Time frame: Baseline, Week 52

  6. Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time

    Time frame: Baseline, Week 52

  7. Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score

    Time frame: Baseline, Week 52

  8. Percentage of Participants with Body Mass Index ≥25 kg/m2 (BMI) Who Achieve Body Weight Reduction of ≥5%

    Time frame: Baseline up to 52 Weeks

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

    Time frame: Baseline up to Week 52

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

    Time frame: Baseline up to Week 52

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 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)

Acronym: RENEW-Scz-1

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 13, 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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