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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|ClinicalTrials.gov Identifier: NCT03818256|
Recruitment Status : Recruiting
First Posted : January 28, 2019
Last Update Posted : January 20, 2021
|Condition or disease||Intervention/treatment||Phase|
|Antipsychotic-induced Weight Gain (AIWG)||Drug: Miricorilant||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Masking Description:||Double Blind|
|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)|
|Actual Study Start Date :||October 31, 2019|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Experimental: CORT118335- 600 mg
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive 600 mg miricorilant for 12 weeks.
Placebo Comparator: Placebo
Patients who meet the entry criteria for the Study CORT118335-876 will be randomized to receive placebo for 12 weeks.
Placebo tablets for once daily oral dosing
- Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo [ Time Frame: Baseline Day 1 to Week 12 ]
- Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation [ Time Frame: Up to Follow-up Visit (up to Week 16) ]
- Percentage of patients achieving more than or equal to 5% weight loss [ Time Frame: Baseline Day 1 to week 12 ]Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo
- Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12 [ Time Frame: Baseline Day 1 to week 12 ]Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo
- Change from baseline in waist-to-hip ratio at Week 12 [ Time Frame: Baseline Day1 to week 12 ]600 mg Miricorilant versus placebo
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03818256
|Contact: Clinical Trial Leademail@example.com|
|Study Director:||Ada Lee, MD||Corcept Therapeutics|