A Study of Brenipatide in Adult Participants With Schizophrenia

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT07410507

Run by

Eli Lilly and Company

People needed

450

Starts

2026-02-10

Expected to finish

2027-11-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Adams Clinical Harlem — New York, New York, United States (enrolling)
• Collaborative Neuroscience Research, LLC — Garden Grove, California, United States (enrolling)
• Clinical Innovations, Inc. dba CITrials — Bellflower, California, United States (enrolling)
• Pillar Clinical Research- Little Rock — Little Rock, Arkansas, United States (enrolling)
• Collaborative Neuroscience Research, LLC — Torrance, California, United States (enrolling)
• Sunwise Clinical Research — Walnut Creek, California, United States (enrolling)
• Institute of Living — Hartford, Connecticut, United States (enrolling)
• Yale University School of Medicine — New Haven, Connecticut, United States (enrolling)
• Magno Medical Research Group — Cooper City, Florida, United States (enrolling)
• Stanford University School of Medicine — Stanford, California, United States (enrolling)
• Innovative Clinical Research — Lauderhill, Florida, United States (enrolling)
• Accel Research Sites - Maitland Clinical Research Unit — Maitland, Florida, United States (enrolling)
• Wellness Research Center — Miami, Florida, United States (enrolling)
• Vital Medical Research — Miami, Florida, United States (enrolling)
• CLA Research — Naples, Florida, United States (enrolling)
• Apg Research, Llc — Orlando, Florida, United States (enrolling)
• Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)
• Augusta University — Augusta, Georgia, United States (enrolling)
• Re:Cognition Health - Chicago — Chicago, Illinois, United States (enrolling)
• CBH Health — Gaithersburg, Maryland, United States (enrolling)
• McLean Hospital — Belmont, Massachusetts, United States (enrolling)
• Adams Clinical Watertown — Watertown, Massachusetts, United States (enrolling)
• University of Massachusetts Chan Medical School — Worcester, Massachusetts, United States (enrolling)
• Arch Clinical Trials — St Louis, Missouri, United States (enrolling)
• Insight Clinical Trials — Independence, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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