A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)
Overview
- Phase
- Phase 2
- Intervention
- Miricorlilant
- Conditions
- Antipsychotic-induced Weight Gain (AIWG)
- Sponsor
- Corcept Therapeutics
- Enrollment
- 150
- Locations
- 36
- Primary Endpoint
- Change From Baseline in Body Weight
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese patients 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 who are currently taking olanzapine, risperidone, paliperidone, or quetiapine. Patients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Have a diagnosis of schizophrenia
- •Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications
- •Must be on a stable dose of medication for 1 month prior to Screening
- •Have a BMI ≥30 kg/m\^2.
Exclusion Criteria
- •Have a history of a medical condition affecting body weight (eg, 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 symptomatic hypotension
- •Have a history of orthostatic hypotension
- •Have a history of a seizure disorder.
Arms & Interventions
Miricorlilant 600 mg
Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Intervention: Miricorlilant
Miricorlilant 900 mg
Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Intervention: Miricorlilant
Placebo
Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Body Weight
Time Frame: Baseline Day 1 and Week 26
Secondary Outcomes
- Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo(Baseline Day 1 and Week 26)
- Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo(Baseline Day 1 and Week 26)
- Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo(Baseline Day 1 to Week 26)