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A Study of Brenipatide in Adult Participants With Schizophrenia

RecruitingPhase 2

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)

Who can join

Ages 18 to 55 · All sexes

Full eligibility 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

About the study

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.

What is being tested

Sponsor: Eli Lilly and Company · Participants: 450 · Started: Feb 10, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07410507

Locations in the U.S.

ArkansasPillar Clinical Research- Little Rock, Little Rock
CaliforniaClinical Innovations, Inc. dba CITrials, Bellflower
Collaborative Neuroscience Research, LLC, Garden Grove
Catalina Research Institute, LLC, Montclair (Not yet recruiting)
Stanford University School of Medicine, Stanford
Collaborative Neuroscience Research, LLC, Torrance
Sunwise Clinical Research, Walnut Creek
ConnecticutInstitute of Living, Hartford
Yale University School of Medicine, New Haven
FloridaMagno Medical Research Group, Cooper City
NextPhase Research Florida - Hollywood, Hollywood
Innovative Clinical Research, Lauderhill
Accel Research Sites - Maitland Clinical Research Unit, Maitland
Vital Medical Research, Miami
Wellness Research Center, Miami
CLA Research, Naples
Apg Research, Llc, Orlando
GeorgiaAtlanta Center for Medical Research, Atlanta
Augusta University, Augusta
IllinoisRe:Cognition Health - Chicago, Chicago
MarylandCBH Health, Gaithersburg
MassachusettsMcLean Hospital, Belmont
Adams Clinical Watertown, Watertown
University of Massachusetts Chan Medical School, Worcester
MissouriArch Clinical Trials, St Louis
New YorkAdams Clinical Harlem, New York
OhioInsight Clinical Trials, Independence
OregonUniversity of Oregon, Eugene
PennsylvaniaAdams Clinical Philadelphia, Philadelphia
TexasAdams Clinical Dallas, DeSoto
Re:Cognition Health - Fort Worth, Fort Worth
WashingtonNorthwest Clinical Research Center, Bellevue

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.