Clinical trial NCT03818256: A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
Official title: 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)
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
Quetiapine
Olanzapine
Bipolar Disorder
Lead sponsor: Corcept Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-01-28
Enrollment: 71
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 adults with schizophrenia or bipolar disorder 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.

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/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.

Primary outcomes:
measure: Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo
timeFrame: Baseline Day 1 and Week 12
measure: Number of Patients With One or More Treatment-emergent Adverse Events
timeFrame: Up to Follow-up Visit (Week 16)
measure: Number of Patients With One or More Treatment-emergent Serious Adverse Events
timeFrame: Up to Follow-up Visit (up to Week 16)
measure: Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation
timeFrame: Up to Follow-up Visit (up to Week 16)
Secondary outcomes:
measure: Percentage of Patients Achieving More Than or Equal to 5% Weight Loss
timeFrame: Baseline Day 1 to Week 12
measure: Change From Baseline in HOMA-IR at Week 12
timeFrame: Baseline Day 1 and Week 12
measure: Change From Baseline in Waist-to-hip Ratio at Week 12
timeFrame: Baseline Day 1 and Week 12
Other outcomes:
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: Lemon Grove
country: United States
facility: Site 134
state: California
city: Oakland
country: United States
facility: Site 126
state: California
city: Oceanside
country: United States
facility: Site 163
state: California
city: Rancho Cucamonga
country: United States
facility: Site 229
state: California
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 140
state: Illinois
city: Lincolnwood
country: United States
facility: Site 140
state: Illinois
city: Wichita
country: United States
facility: Site 146
state: Kansas
city: Glen Burnie
country: United States
facility: Site 138
state: Maryland
city: Las Vegas
country: United States
facility: Site 151
state: Nevada
city: New York
country: United States
facility: Site 216
state: New York
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: Thorndale
country: United States
facility: Site 235
state: Pennsylvania
city: West Chester
country: United States
facility: Site 235
state: Pennsylvania
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: Salt Lake City
country: United States
facility: Site 139
state: Utah
city: Bellevue
country: United States
facility: Site 137
state: Washington
Study officials:
affiliation: Corcept Therapeutics
name: Kavita Juneja, MD
role: STUDY_DIRECTOR
References: