A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
Overview
- Phase
- Phase 2
- Intervention
- Miricorilant
- Conditions
- Antipsychotic-induced Weight Gain (AIWG)
- Sponsor
- Corcept Therapeutics
- Enrollment
- 71
- Locations
- 24
- Primary Endpoint
- Number of Patients With One or More Treatment-emergent Adverse Events
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant in obese adult with schizophrenia treated with antipsychotic medications.
Detailed Description
This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication. Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to receive 600 mg miricorilant or placebo for 12 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a diagnosis of schizophrenia or bipolar disorder
- •Are currently taking oral or injectable atypical antipsychotic medication (except clozapine) and must have documented weight gain while on these medications
- •Must be on a stable dose of medication for 1 month prior to screening
- •Are able to successfully complete placebo tablet swallow test
- •Have a BMI ≥30 kg/m2
Exclusion Criteria
- •Have a history of a medical condition affecting body weight (e.g., poorly controlled hyper- or hypothyroidism; eating disorder such as anorexia, bulimia, or binge eating; or polycystic ovary syndrome).
- •Have poorly controlled diabetes mellitus
- •Have poorly controlled hypertension
- •Have a history of hypotension
- •Have a history of orthostatic hypotension
Arms & Interventions
Miricorilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.
Intervention: Miricorilant
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Number of Patients With One or More Treatment-emergent Adverse Events
Time Frame: Up to Follow-up Visit (Week 16)
Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo
Time Frame: Baseline Day 1 and Week 12
Number of Patients With One or More Treatment-emergent Serious Adverse Events
Time Frame: Up to Follow-up Visit (up to Week 16)
Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation
Time Frame: Up to Follow-up Visit (up to Week 16)
Secondary Outcomes
- Percentage of Patients Achieving More Than or Equal to 5% Weight Loss(Baseline Day 1 to Week 12)
- Change From Baseline in HOMA-IR at Week 12(Baseline Day 1 and Week 12)
- Change From Baseline in Waist-to-hip Ratio at Week 12(Baseline Day 1 and Week 12)