Phase 2
Completed N=71
A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications
Antipsychotic-induced Weight Gain (AIWG)
Source: ClinicalTrials.gov NCT03818256 ↗
Enrolled (actual)
71
Serious AEs
2.8%
Results posted
Sep 2024
Primary outcomePrimary: Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo — -0.98; -1.08 kg — p=0.8511
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo |
-0.98; -1.08 | 0.8511 |
| PRIMARY Number of Patients With One or More Treatment-emergent Adverse Events |
16; 18 | — |
| PRIMARY Number of Patients With One or More Treatment-emergent Serious Adverse Events |
1; 1 | — |
| PRIMARY Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation |
3; 1 | — |
| SECONDARY Percentage of Patients Achieving More Than or Equal to 5% Weight Loss |
2; 3 | 0.8169 |
| SECONDARY Change From Baseline in HOMA-IR at Week 12 |
1.080; 0.890 | 0.9285 |
| SECONDARY Change From Baseline in Waist-to-hip Ratio at Week 12 |
0.008; 0.001 | 0.5669 |
Eligibility 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/m^2.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03818256). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.