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Brenipatide added to standard care for adults with schizophrenia

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)

Phase 2 Interventional Eli Lilly and Company · NCT07410507

This will see if adding brenipatide to your usual schizophrenia medication helps more than a placebo plus standard care for adults with schizophrenia.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment450 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Locations102 sites (Little Rock, Arkansas and 101 other locations)
Trial IDNCT07410507 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults with a diagnosis of schizophrenia who are on a stable standard-of-care medication regimen, have a reliable study partner, and are willing to self-inject and attend required visits are ideal candidates.

Not a fit: People with a lifetime history of bipolar disorder, borderline personality disorder, eating disorders, or recent moderate/severe substance or alcohol use disorder, or those not on stable treatment or unable to self-inject or attend visits, are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, adding brenipatide to usual treatment may reduce symptoms or lower relapse risk for some adults with schizophrenia.

How similar studies have performed: Previous add-on medication trials for schizophrenia have shown mixed results, so this specific approach remains experimental and not yet proven.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Little Rock, Arkansas and 101 other locations

+52 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Schizophrenia
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.