A Study of Brenipatide in Adult Participants With Schizophrenia

NCT07410507
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Participants
450
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2026-02-10
clinicaltrials.gov
Number of sites
101
clinicaltrials.gov

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.
clinicaltrials.gov
Acronym
RENEW-Scz-1
clinicaltrials.gov
Short title
A Study of Brenipatide in Adult Participants With Schizophrenia
clinicaltrials.gov
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)
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Recruiting
clinicaltrials.gov
Phase
Phase 2
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-11-01
clinicaltrials.gov
First posted
2026-02-13
clinicaltrials.gov
Registry last updated
2026-10-07
clinicaltrials.gov
Primary completion date
2027-11-01
clinicaltrials.gov
Start date
2026-02-10
clinicaltrials.gov

Participants
450
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
450
clinicaltrials.gov
Protocol amendments
0
clinicaltrials.gov
Number of sites
101
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT07410507
clinicaltrials.gov
ClinicalTrials.gov ID
NCT07410507
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)

    Timeframe: Baseline, Week 52

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

    Timeframe: Baseline, Week 36

  2. Time to Relapse

    Timeframe: 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)

    Timeframe: Baseline, Week 52

  4. Change from Baseline in Patient Global Impression - Severity

    Timeframe: Baseline, Week 52

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

    Timeframe: Baseline, Week 52

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

    Timeframe: Baseline, Week 52

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

    Timeframe: Baseline, Week 52

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

    Timeframe: Baseline up to 52 Weeks

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

    Timeframe: Baseline up to Week 52

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

    Timeframe: Baseline up to Week 52

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
55 Years
Healthy volunteers
No

  • 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
Sources for eligibility
clinicaltrials.gov

  • Pillar Clinical Research- Little RockLittle Rock, United StatesRecruiting
  • Clinical Innovations, Inc. dba CITrialsBellflower, United StatesRecruiting
  • Collaborative Neuroscience Research, LLCGarden Grove, United StatesRecruiting
  • Catalina Research Institute, LLCMontclair, United StatesRecruiting
  • Stanford University School of MedicineStanford, United StatesRecruiting
  • Collaborative Neuroscience Research, LLCTorrance, United StatesRecruiting
  • Sunwise Clinical ResearchWalnut Creek, United StatesRecruiting
  • Institute of LivingHartford, United StatesRecruiting
  • Yale University School of MedicineNew Haven, United StatesRecruiting
  • Magno Medical Research GroupCooper City, United StatesRecruiting
  • NextPhase Research Florida - HollywoodHollywood, United StatesRecruiting
  • Innovative Clinical ResearchLauderhill, United StatesRecruiting
  • Accel Research Sites - Maitland Clinical Research UnitMaitland, United StatesRecruiting
  • Wellness Research CenterMiami, United StatesRecruiting
  • Vital Medical ResearchMiami, United StatesRecruiting
  • CLA ResearchNaples, United StatesRecruiting
  • Apg Research, LlcOrlando, United StatesRecruiting
  • Atlanta Center for Medical ResearchAtlanta, United StatesRecruiting
  • Augusta UniversityAugusta, United StatesRecruiting
  • Re:Cognition Health - ChicagoChicago, United StatesRecruiting
  • CBH HealthGaithersburg, United StatesRecruiting
  • McLean HospitalBelmont, United StatesRecruiting
  • Adams Clinical WatertownWatertown, United StatesRecruiting
  • University of Massachusetts Chan Medical SchoolWorcester, United StatesRecruiting
  • Arch Clinical TrialsSt Louis, United StatesRecruiting

And 76 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • J2S-MC-GZMK
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)