Status:
COMPLETED
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
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 patients with schizophrenia treated ...
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, ris...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT04524403
Start Date
September 9 2020
End Date
August 25 2022
Last Update
June 13 2024
Active Locations (40)
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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