> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-brenipatide-in-adult-participants-with-1edaff71-0e3b-4b7a-bfee-c4db904fa313 > Record changed: 2026-11-04 # A Study of Brenipatide in Adult Participants With Schizophrenia NCT07410507 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) Participants 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) Lead sponsor Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) Start date 2026-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) Number of sites 101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Acronym** RENEW-Scz-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Short title** A Study of Brenipatide in Adult Participants With Schizophrenia Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Dates **Completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **First posted** 2026-02-13 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Registry last updated** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Primary completion date** 2027-11-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Start date** 2026-02-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Size and sites **Participants** 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Planned participants** 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Number of sites** 101 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Lead sponsor** Eli Lilly and Company Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Identifiers **Registry ID** NCT07410507 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **ClinicalTrials.gov ID** NCT07410507 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Outcomes ### 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) Timeframe: Baseline, Week 52 ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Eligibility **Sex** All **Age groups** Adults **Minimum age** 18 Years **Maximum age** 55 Years **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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Sites - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## References - Related resource (trials.lilly.com) Source: [trials.lilly.com](https://trials.lilly.com/ext/trial?id=J2S-MC-GZMK) ### Other registry identifiers - J2S-MC-GZMK Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07410507) ## Related records ### Drugs (1) - [Brenipatide](https://trialight.com/data/asset/brenipatide-4758d77a-80b3-5d20-93d3-fc5bfaf5857c.md) ### Lead sponsors (1) - [Eli Lilly and Company](https://trialight.com/data/company/eli-lilly-and-company-9da7efcc-bafe-4b95-b30b-e87a97770db7.md) ### Conditions (1) - [Schizophrenia](https://trialight.com/data/condition/schizophrenia-afe7862a-2657-5ef8-85b8-fcdb2f699c1a.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. 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