Clinical trial NCT04524403: A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Antipsychotic-induced Weight Gain (AIWG)
Keywords: Antipsychotic-induced weight gain (AIWG)
Obesity
Weight Gain
Mental disorders
Schizophrenia
Risperidone
Paliperidone
Quetiapine
Olanzapine
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2020-08-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change From Baseline in Body Weight
timeFrame: Baseline Day 1 and Week 26
Secondary outcomes:
measure: Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo
timeFrame: Baseline Day 1 and Week 26
measure: Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo
timeFrame: Baseline Day 1 to Week 26
measure: Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo
timeFrame: Baseline Day 1 and Week 26
Other outcomes:
measure: Number of Patients With One or More Treatment-emergent Adverse Events
timeFrame: Baseline Day 1 to Week 30
measure: Number of Patients With One or More Treatment-emergent Serious Adverse Events
timeFrame: Baseline Day 1 to Week 30
measure: Number of Patients With One or More Treatment-emergent Adverse Events Leading to Study Drug Discontinuation
timeFrame: Baseline Day 1 to Week 30
Locations:
city: Bentonville
country: United States
facility: Site #143
state: Arkansas
city: Little Rock
country: United States
facility: Site # 249
state: Arkansas
city: Culver City
country: United States
facility: Site #153
state: California
city: Garden Grove
country: United States
facility: Site #239
state: California
city: Glendale
country: United States
facility: Site # 243
state: California
city: Lemon Grove
country: United States
facility: Site #134
state: California
city: Oceanside
country: United States
facility: Site #163
state: California
city: Pico Rivera
country: United States
facility: Site # 247
state: California
city: Rancho Cucamonga
country: United States
facility: Site # 229
state: California
city: San Diego
country: United States
facility: Site # 237
state: California
city: Stanford
country: United States
facility: Site # 150
state: California
city: Miami Lakes
country: United States
facility: Site #144
state: Florida
city: Miami
country: United States
facility: Site #202
state: Florida
city: North Miami
country: United States
facility: Site #144
state: Florida
city: Okeechobee
country: United States
facility: Site #241
state: Florida
city: Chicago
country: United States
facility: Site # 240
state: Illinois
city: Chicago
country: United States
facility: Site #140
state: Illinois
city: Lincolnwood
country: United States
facility: Site #140
state: Illinois
city: Flowood
country: United States
facility: Site #225
state: Mississippi
city: Saint Louis
country: United States
facility: Site #224
state: Missouri
city: Lincoln
country: United States
facility: Site #217
state: Nebraska
city: Las Vegas
country: United States
facility: Site #151
state: Nevada
city: Cedarhurst
country: United States
facility: Site # 244
state: New York
city: New York
country: United States
facility: Site #216
state: New York
city: New York
country: United States
facility: Site # 245
state: New York
city: Staten Island
country: United States
facility: Site #231
state: New York
city: Staten Island
country: United States
facility: Site #231
state: New York
city: Charlotte
country: United States
facility: Site # 248
state: North Carolina
city: Raleigh
country: United States
facility: Site #181
state: North Carolina
city: Raleigh
country: United States
facility: Site # 181
state: North Carolina
city: Dayton
country: United States
facility: Site #107
state: Ohio
city: North Canton
country: United States
facility: Site # 230
state: Ohio
city: Philadelphia
country: United States
facility: Site #166
state: Pennsylvania
city: Thorndale
country: United States
facility: Site #235
state: Pennsylvania
city: West Chester
country: United States
facility: Site #235
state: Pennsylvania
city: Austin
country: United States
facility: Site #223
state: Texas
city: DeSoto
country: United States
facility: Site #206
state: Texas
city: Houston
country: United States
facility: Site #066
state: Texas
city: Richardson
country: United States
facility: Site #165
state: Texas
city: Bellevue
country: United States
facility: Site #137
state: Washington
Study officials:
affiliation: Corcept Therapeutics
name: Kavita Juneja, MD
role: STUDY_DIRECTOR
References: