A Study of Brenipatide in Adult Participants With Schizophrenia

Conditions

• Schizophrenia

Eligibility Criteria

Sex

ALL

Age

18 Years - 55 Years

Healthy Volunteers

Not accepted

Interventions

• Brenipatide — DRUG
  Administered SC
• Placebo — DRUG
  Administered SC

Study Details

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.

Key Dates

Start date

Feb 10, 2026

Status verified

Jun 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

450 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Brenipatide
  Brenipatide administered subcutaneously (SC) + SoC.
• Placebo Comparator: Placebo
  Placebo administered SC + SoC.

Primary Outcome Measure

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 ]

Central Contacts

• Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
  1-317-615-4559
  [email protected]
• Physicians interested in becoming principal investigators please contact
  [email protected]

Locations (31)

Find similar trials in Little Rock, AR

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