A Study of Brenipatide in Adult Participants With Schizophrenia

Official title

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)

Overview

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.

Interventions

• Drug Brenipatide
  Administered SC
• Drug Placebo
  Administered SC

Primary outcome measures

• Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²) [Time frame: Baseline, Week 52]

Secondary outcome measures (10)

• Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36 [Time frame: Baseline, Week 36]
• Time to Relapse [Time frame: Randomization up to Week 52]
• Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH) [Time frame: Baseline, Week 52]
• Change from Baseline in Patient Global Impression - Severity [Time frame: Baseline, Week 52]
• Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score [Time frame: Baseline, Week 52]
• Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time [Time frame: Baseline, Week 52]
• Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score [Time frame: Baseline, Week 52]
• Percentage of Participants with Body Mass Index ≥25 kg/m2 (BMI) Who Achieve Body Weight Reduction of ≥5% [Time frame: Baseline up to 52 Weeks]
• Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide [Time frame: Baseline up to Week 52]
• Number of Participants with Treatment-Emergent Anti-Drug Antibodies [Time frame: Baseline up to Week 52]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 32 centers

• Pillar Clinical Research- Little Rock — Little Rock
• Clinical Innovations, Inc. dba CITrials — Bellflower
• Collaborative Neuroscience Research, LLC — Garden Grove
• Catalina Research Institute, LLC — Montclair
• Stanford University School of Medicine — Stanford
• Collaborative Neuroscience Research, LLC — Torrance
• Sunwise Clinical Research — Walnut Creek
• Institute of Living — Hartford
• … and 24 more centers

Japan · 16 centers

• Uematsu Mental Clinic — Chikugo
• Horikoshi Mental Somatic Clinic — Fukushima
• Seinan Hospital — Hachinohe
• … and 13 more centers

Argentina · 13 centers

• Centro Neurobiológico y de Estrés Traumático (CENydET) — Buenos Aires
• Fundación para el Estudio y Tratamiento de Enfermedades Mentales (FETEM) — Buenos Aires
• Instituto Nacional de Psicopatología (INAPsi)- FunDaMos — Buenos Aires
• Centro de Investigaciones Metabólicas (CINME) — Buenos Aires
• CEN Centro Especializado en Neurociencias — Córdoba
• Sanatorio Morra S.A. — Córdoba
• Instituto Kremer — Córdoba
• Centro Médico Luquez — Córdoba
• … and 5 more centers

India · 13 centers

• Galaxy Superspeciality Hospital — Aurangabad
• All India Institute of Medical Sciences (AIIMS) - Bhopal — Bhopal
• Rajiv Gandhi Government General Hospital — Chennai
• Graphic Era Institute of Medical Sciences and Hospital — Dehradun
• Dharwad Institute Of Mental Health And Neurosciences — Dharwad
• Calida Rehab - Karjat — Karjat
• Shree Mahalaxmi DIATONE Institute — Kolhāpur
• Dr. Ram Manohar Lohia Institute of Medical Sciences — Lucknow
• … and 5 more centers

Brazil · 11 centers

• Hospital das Clínicas da UFMG — Belo Horizonte
• Chronos Pesquisa Clínica — Brasília
• Instituto de Pesquisa clinica de Campinas — Campinas
• Trial Tech — Curitiba
• Clinilive — Maringá
• Instituto Atena de Pesquisa Clinica — Natal
• Ruschel Medicina e Pesquisa Clínica — Rio de Janeiro
• Instituto Apice — Salvador
• … and 3 more centers

Taiwan · 10 centers

Center list to be confirmed — check the primary protocol.

China · 8 centers

• The Second Xiangya Hospital of Central South University — Changsha
• The Fourth People's Hospital of Chengdu — Chengdu
• The Seventh People's Hospital of Hangzhou — Hangzhou
• Suzhou Guangji Hospital — Suzhou
• Tianjin Anding Hospital — Tianjin
• Wuhu Hospital of Beijing Anding hospital — Wuhu
• Xi An Mental Health Center — Xi'an
• Zhumadian Psychiatric Hospital — Zhumadian

Identifiers

NCT: NCT07410507 · 27366 · J2S-MC-GZMK

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗