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A Study of Brenipatide in Adult Participants With Schizophrenia

ConditionSchizophrenia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-55
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Brenipatide

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

450 Participants
are divided into 2 treatment groups
Group A: BrenipatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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 outcomes

1

Change from Baseline on Neurocognitive Battery Composite Test Score at Week 36

Time frame
Baseline, Week 36
2

Time to Relapse

Time to relapse defined as days from randomization to the dates on which the participant meets any relapse criteria.

Time frame
Randomization up to Week 52
3

Change from Baseline in Clinical Global Impression - Severity - Schizophrenia (CGI-S-SCH)

Time frame
Baseline, Week 52
4

Change from Baseline in Patient Global Impression - Severity

Time frame
Baseline, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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