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Clinical Trials/NCT07410507
NCT07410507
Recruiting
Phase 2

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)

Eli Lilly and Company189 sites in 3 countries450 target enrollmentStarted: February 10, 2026Last updated:
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InterventionsBrenipatidePlacebo

Overview

Phase
Phase 2
Status
Recruiting
Enrollment
450
Locations
189
Primary Endpoint
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Brenipatide

Experimental

Brenipatide administered subcutaneously (SC) + SoC.

Intervention: Brenipatide (Drug)

Placebo

Placebo Comparator

Placebo administered SC + SoC.

Intervention: Placebo (Drug)

Outcomes

Primary Outcomes

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

  • Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36(Baseline, Week 36)
  • Time to Relapse(Randomization up to Week 52)
  • Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH)(Baseline, Week 52)
  • Change from Baseline in Patient Global Impression - Severity(Baseline, Week 52)
  • Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline, Week 52)
  • Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time(Baseline, Week 52)
  • Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score(Baseline, Week 52)
  • Percentage of Participants with Body Mass Index ≥25 kg/m2 (BMI) Who Achieve Body Weight Reduction of ≥5%(Baseline up to 52 Weeks)
  • Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide(Baseline up to Week 52)
  • Number of Participants with Treatment-Emergent Anti-Drug Antibodies(Baseline up to Week 52)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (189)

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