Brenipatide added to standard care for adults with schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2, placebo-controlled study compares brenipatide plus standard of care to placebo plus standard of care in adults diagnosed with schizophrenia. Eligible participants must be on a stable schizophrenia medication regimen, have at least one reliable study partner, and be willing to self-administer injections and complete study diaries and questionnaires. The study includes a screening period of about one month, a treatment period up to 12 months, and a follow-up of approximately two months, with total participation up to about 15 months. Safety and symptom outcomes will be recorded throughout the treatment and follow-up periods.

Why it matters

Who can join: the full rules

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

Where it's running

• Pillar Clinical Research- Little Rock
  Little Rock, Arkansas, United States Recruiting
• Clinical Innovations, Inc. dba CITrials
  Bellflower, California, United States Recruiting
• Collaborative Neuroscience Research, LLC
  Garden Grove, California, United States Recruiting
• Catalina Research Institute, LLC
  Montclair, California, United States Recruiting
• Stanford University School of Medicine
  Stanford, California, United States Recruiting
• Collaborative Neuroscience Research, LLC
  Torrance, California, United States Recruiting

+51 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neuronavigated rTMS for treatment-resistant auditory hallucinations

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.