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RecruitingPhase 2

A Study of Brenipatide in Adult Participants 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 55 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 15 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The length of time of your study participation may last up to approximately 15 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well brenipatide works and how safe it is for adults with schizophrenia. It compares brenipatide plus usual treatment with a placebo (a treatment with no active drug) plus usual treatment. Taking part may last up to about 15 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of schizophrenia.
  • Be on a steady plan of usual medicines for schizophrenia.
  • If you have had schizophrenia for more than 6 years, have had symptoms return or get worse at least once in the past 3 years.
  • Have at least one dependable study partner, such as a family member, social worker, or nurse.
  • Be willing and able to take part for the full study, attend required visits, and follow study instructions.
  • Be able to give yourself study injections and store and use the study treatment as directed.
  • Be able to keep electronic or paper study diaries and fill out required questionnaires.

Who can't join

  • Have ever had bipolar disorder, borderline personality disorder, or an eating disorder.
  • Have signs of a moderate or severe alcohol or drug use disorder within 180 days before screening.
  • Have type 1 diabetes, or have had ketoacidosis (dangerous acid buildup in the blood), a hyperosmolar state (very high blood sugar with severe water loss), or coma.
  • Are actively suicidal or are judged to have a high risk of suicide.
  • Are in another study testing an experimental treatment, or in other medical research judged to conflict with this study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (32)

AR

CA

CT

FL

GA

IL

MA

MD

MO

NY

OH

OR

PA

TX

WA