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)
Verified date | February 2023 |
Source | Corcept Therapeutics |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.
Status | Completed |
Enrollment | 151 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
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/m2 Exclusion Criteria: - Have a history of a medical condition affecting body weight (e.g., 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 hypotension - Have a history of orthostatic hypotension - Have a history of a seizure disorder |
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 #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 # 235 | Media | Pennsylvania |
United States | Site #202 | Miami | 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 # 247 | Pico Rivera | California |
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 |
Lead Sponsor | Collaborator |
---|---|
Corcept Therapeutics |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in body weight | Baseline Day 1 to Week 26 | ||
Secondary | Change from baseline in body weight for both dose levels of miricorilant combined versus placebo | Change from baseline in body weight for both 600 mg and 900 mg dose levels combined of miricorilant versus placebo | Baseline Day 1 to 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 | Both dose levels versus placebo | Baseline Day 1 to Week 26 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03818256 -
This Phase 2, Double Blind, Placebo-controlled, Randomized Study is to Assess the Safety and Efficacy of Miricorilant in Obese Adult With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications.
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Phase 2 |