Schizophrenia
Conditions
Brief summary
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
DRUGBrenipatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change from Baseline in Body Weight in Participants with a Baseline Body Mass Index ≥25.0 Kilograms per Meter Squared (kg/m²) | Baseline, Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36 | Baseline, Week 36 | — |
| Time to Relapse | Randomization up to Week 52 | Time to relapse defined as days from randomization to the dates on which the participant meets any relapse criteria. |
| Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH) | Baseline, Week 52 | — |
| Change from Baseline in Patient Global Impression - Severity | Baseline, Week 52 | — |
| Change from Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score | Baseline, Week 52 | — |
| Change from Baseline on the Virtual Reality Functional Capacity Assessment Tool (VRFCAT) Total Completion Time | Baseline, Week 52 | — |
| Change from Baseline on the Schizophrenia Cognition Rating Scale (SCoRS) Total Score | Baseline, Week 52 | — |
| Percentage of Participants with Body Mass Index ≥25 kg/m2 (BMI) Who Achieve Body Weight Reduction of ≥5% | Baseline up to 52 Weeks | — |
| Pharmacokinetic (PK): Average Steady State Plasma Concentration (Cavg) of Brenipatide | Baseline up to Week 52 | — |
| Number of Participants with Treatment-Emergent Anti-Drug Antibodies | Baseline up to Week 52 | — |
Countries
Argentina, Brazil, China, India, Japan, Taiwan, United States
Contacts
CONTACTTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACTPhysicians interested in becoming principal investigators please contact
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed