A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)

Phase 2

Completed

• Conditions: Antipsychotic-induced Weight Gain (AIWG)
• Interventions: Drug: Miricorlilant; Drug: Placebo

• Registration Number: NCT04524403
• Lead Sponsor: Corcept Therapeutics

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.

Study Timeline

• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-21
• Study First Posted: 2020-08-24
• Study Start: 2020-09-09
• Primary Completion: 2022-07-29
• Study Completion: 2022-08-25
• Status Verified: 2024-05
• Results First Submitted: 2024-05-21
• Results First Submitted QC: 2024-05-21
• Last Update Submitted: 2024-05-21
• Results First Posted: 2024-06-13
• Last Update Posted: 2024-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Miricorlilant 600 mg	Miricorlilant	Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant 900 mg	Miricorlilant	Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
Placebo	Placebo	Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight	Baseline Day 1 and Week 26

Secondary Outcome Measures

Name	Time	Method
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	Percentage of patients achieving a ≥5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo

Trial Locations

Locations (36)

Site # 240; 🇺🇸 Chicago, Illinois, United States

Site #166; 🇺🇸 Philadelphia, Pennsylvania, United States

Site #143; 🇺🇸 Bentonville, Arkansas, United States

Site #239; 🇺🇸 Garden Grove, California, United States

Site # 243; 🇺🇸 Glendale, California, United States

Site #224; 🇺🇸 Saint Louis, Missouri, United States

Site # 249; 🇺🇸 Little Rock, Arkansas, United States

Site #181; 🇺🇸 Raleigh, North Carolina, United States

Site #153; 🇺🇸 Culver City, California, United States

Site # 181; 🇺🇸 Raleigh, North Carolina, United States

Site #134; 🇺🇸 Lemon Grove, California, United States

Site #231; 🇺🇸 Staten Island, New York, United States

Site #163; 🇺🇸 Oceanside, California, United States

Site #140; 🇺🇸 Lincolnwood, Illinois, United States

Site #217; 🇺🇸 Lincoln, Nebraska, United States

Site #216; 🇺🇸 New York, New York, United States

Site # 247; 🇺🇸 Pico Rivera, California, United States

Site #202; 🇺🇸 Miami, Florida, United States

Site # 237; 🇺🇸 San Diego, California, United States

Site #151; 🇺🇸 Las Vegas, Nevada, United States

Site # 229; 🇺🇸 Rancho Cucamonga, California, United States

Site #144; 🇺🇸 North Miami, Florida, United States

Site # 150; 🇺🇸 Stanford, California, United States

Site # 245; 🇺🇸 New York, New York, United States

Site #241; 🇺🇸 Okeechobee, Florida, United States

Site # 244; 🇺🇸 Cedarhurst, New York, United States

Site #225; 🇺🇸 Flowood, Mississippi, United States

Site # 248; 🇺🇸 Charlotte, North Carolina, United States

Site #107; 🇺🇸 Dayton, Ohio, United States

Site # 230; 🇺🇸 North Canton, Ohio, United States

Site #165; 🇺🇸 Richardson, Texas, United States

Site #235; 🇺🇸 West Chester, Pennsylvania, United States

Site #206; 🇺🇸 DeSoto, Texas, United States

Site #066; 🇺🇸 Houston, Texas, United States

Site #137; 🇺🇸 Bellevue, Washington, United States

Site #223; 🇺🇸 Austin, Texas, United States