drugset
drugset / Trial / NCT03818256

A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications

NCT03818256 ↗

Phase 2 Completed 71 enrolled Corcept Therapeutics
RandomizedParallel-groupTriple-blindTreatment

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 disorder treated with antipsychotic medications.

Timeline

Start
2019-12-04
Primary completion
2022-06-17
Completion
2022-07-06

Outcome

Missed primary endpoint

registry analysis (superiority test); Miricorilant 600 mg vs Placebo; p = 0.8511; Least Squares Mean Difference 0.11 (95% CI -1.03 to 1.24); Mixed Models Analysis NCT03818256 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Miricorilant Small molecule 600 mg Oral

Indications

No indication recorded.