Status:
COMPLETED
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
Lead Sponsor:
Corcept Therapeutics
Conditions:
Antipsychotic-induced Weight Gain (AIWG)
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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...
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 ta...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2022
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03818256
Start Date
December 4 2019
End Date
July 6 2022
Last Update
September 19 2024
Active Locations (27)
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1
Site 143
Bentonville, Arkansas, United States, 72712
2
Site 249
Little Rock, Arkansas, United States, 72211
3
Site 153
Culver City, California, United States, 90230
4
Site 239
Garden Grove, California, United States, 92845