Miami, Florida 33122

  • induced Weight Gain (AIWG)

Purpose:

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant in obese adult with schizophrenia treated with antipsychotic medications.


Study summary:

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.


Criteria:

Inclusion Criteria: - 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/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


NCT ID:

NCT03818256


Primary Contact:

Study Director
Ada Lee, MD
Corcept Therapeutics

Clinical Trial Lead
Phone: 650-327-3270
Email: study876ctgov@corcept.com


Backup Contact:

N/A


Location Contact:

Miami, Florida 33122
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 19, 2021

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