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

Antipsychotic-induced Weight Gain (AIWG) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524403
• Other study ID #: CORT118335-877
• Status: Completed
• Phase: Phase 2
• Start date: September 9, 2020
• Est. completion date: August 25, 2022

Study information

• Verified date: May 2024
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 25, 2022
• Est. primary completion date: July 29, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Antipsychotic-induced Weight Gain (AIWG)
• Schizophrenia
• Weight Gain

Intervention

Drug:
• Miricorlilant
Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
• Miricorlilant
Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
• Placebo
Placebo for once-daily oral dosing

Locations

Country	Name	City	State
United States	Site #223	Austin	Texas
United States	Site #137	Bellevue	Washington
United States	Site #143	Bentonville	Arkansas
United States	Site # 244	Cedarhurst	New York
United States	Site # 248	Charlotte	North Carolina
United States	Site # 240	Chicago	Illinois
United States	Site #140	Chicago	Illinois
United States	Site #153	Culver City	California
United States	Site #107	Dayton	Ohio
United States	Site #206	DeSoto	Texas
United States	Site #225	Flowood	Mississippi
United States	Site #239	Garden Grove	California
United States	Site # 243	Glendale	California
United States	Site #066	Houston	Texas
United States	Site #151	Las Vegas	Nevada
United States	Site #134	Lemon Grove	California
United States	Site #217	Lincoln	Nebraska
United States	Site #140	Lincolnwood	Illinois
United States	Site # 249	Little Rock	Arkansas
United States	Site #202	Miami	Florida
United States	Site #144	Miami Lakes	Florida
United States	Site # 245	New York	New York
United States	Site #216	New York	New York
United States	Site # 230	North Canton	Ohio
United States	Site #144	North Miami	Florida
United States	Site #163	Oceanside	California
United States	Site #241	Okeechobee	Florida
United States	Site #166	Philadelphia	Pennsylvania
United States	Site # 247	Pico Rivera	California
United States	Site # 181	Raleigh	North Carolina
United States	Site #181	Raleigh	North Carolina
United States	Site # 229	Rancho Cucamonga	California
United States	Site #165	Richardson	Texas
United States	Site #224	Saint Louis	Missouri
United States	Site # 237	San Diego	California
United States	Site # 150	Stanford	California
United States	Site #231	Staten Island	New York
United States	Site #231	Staten Island	New York
United States	Site #235	Thorndale	Pennsylvania
United States	Site #235	West Chester	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Patients With One or More Treatment-emergent Adverse Events		Baseline Day 1 to Week 30
Other	Number of Patients With One or More Treatment-emergent Serious Adverse Events		Baseline Day 1 to Week 30
Other	Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation		Baseline Day 1 to Week 30
Primary	Change From Baseline in Body Weight		Baseline Day 1 and Week 26
Secondary	Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo		Baseline Day 1 and Week 26
Secondary	Percentage of Patients Achieving a =5% Weight Loss for Miricorilant Versus Placebo	Percentage of patients achieving a =5% weight loss for 600 mg miricorilant versus placebo and 900 mg miricorilant versus placebo	Baseline Day 1 to Week 26
Secondary	Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo		Baseline Day 1 and Week 26