Study Evaluating the Safety Efficacy and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)

  • STATUS
    Recruiting
  • End date
    Jun 27, 2022
  • participants needed
    150
  • sponsor
    Corcept Therapeutics
Updated on 27 January 2021

Summary

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.

Description

This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant in obese patients with schizophrenia who are currently taking olanzapine, risperidone, paliperidone, or quetiapine.

Patients who meet the criteria for the Study CORT118335-877 will be randomized on Day 1 to receive 600 mg miricorilant, 900 mg miricorilant, or placebo for 26 weeks.

Details
Condition Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG), Antipsychotic-induced Weight Gain (AIWG)
Treatment Miricorlilant
Clinical Study IdentifierNCT04524403
SponsorCorcept Therapeutics
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 65 yrs?
Gender: Male or Female
Do you have Antipsychotic-induced Weight Gain (AIWG)?
Do you have any of these conditions: Do you have Antipsychotic-induced Weight Gain (AIWG)??
Do you have any of these conditions: Do you have Antipsychotic-induced Weight Gain (AIWG)??
Do you have any of these conditions: Do you have Antipsychotic-induced Weight Gain (AIWG)??
Do you have any of these conditions: Do you have Antipsychotic-induced Weight Gain (AIWG)??
Do you have any of these conditions: Do you have Antipsychotic-induced Weight Gain (AIWG)??
Do you have any of these conditions: Do you have Antipsychotic-induced Weight Gain (AIWG)??
Do you have any of these conditions: Do you have Antipsychotic-induced Weight Gain (AIWG)??
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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