A Study of Brenipatide in Adult Participants With Schizophrenia

ClinicalTrials.gov ID

NCT07410507

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

450Estimated

Last Update Posted

Sep 4, 2026Actual

Start Date

Feb 10, 2026Actual

Primary Completion Date

Nov 2027Estimated

Completion Date

Nov 2027Estimated

Official 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)

Brief Summary

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.

• Schizophrenia

• Brenipatide
• Placebo

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Double

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

305-300-2623

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