Brenipatide for Schizophrenia Study

This study is testing a drug called brenipatide in adults with schizophrenia. Researchers want to see if brenipatide, when given along with your usual schizophrenia medication, is safe and effective compared to a placebo (an inactive substance). You might be able to join if you are 18 to 55 years old, have schizophrenia, and are on a stable medication regimen. If you've had schizophrenia for more than 6 years, you must have experienced at least one relapse in the last three years. The main goal is to see how brenipatide affects body weight over 52 weeks in participants with a BMI of 25.0 kg/m² or higher. The study plans to enroll 450 participants, but its current recruitment status is unclear.

Study design
This is an interventional study comparing brenipatide to a placebo. It plans to enroll 450 adult participants.
What's involved
Your participation could last up to approximately 15 months, including a 1-month screening, up to 12 months of treatment, and about 2 months of follow-up.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for approximately 2 months after the treatment period, with body weight measured at Week 52.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07410507

A Study of Brenipatide in Adult Participants With Schizophrenia

Recruiting
PHASE2Ages 18–55InterventionalTreatment
Eli Lilly and Company
~450 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:BrenipatidePlacebo

At a glance

Recruiting sites
84 of 103 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)
Measured over Baseline, Week 52
Schizophrenia
103 sites across 21 states
Japan16
Argentina13
India13
Brazil11
Taiwan10
Florida8
China8
California6
  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) · STUDY_DIRECTOR · Eli Lilly and Company
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²)Baseline, Week 52