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.

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Corcept Therapeutics
• Treatments: Antipsychotic Agents; Cortisone; Cortisone acetate

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