Phase 2
Completed N=150
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
Antipsychotic-induced Weight Gain (AIWG)
Source: ClinicalTrials.gov NCT04524403 ↗
Enrolled (actual)
150
Serious AEs
3.3%
Results posted
Jun 2024
Primary outcomePrimary: Change From Baseline in Body Weight — -1.41; -0.91; -1.66 kg — p=0.7870
Summary
This Phase 2, double-blind, placebo-controlled, randomized study is to assess the safety, efficacy, and pharmacokinetics (PK) of miricorilant (CORT118335) in obese patients with schizophrenia treated with antipsychotic medications.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Weight |
-1.41; -0.91; -1.66 | 0.7870 |
| SECONDARY Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo |
-1.16; -1.65 | 0.5228 |
| SECONDARY Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo |
12; 7; 8 | 0.2537 |
| SECONDARY Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo |
0.002; 0.009; 0.002 | 0.9870 |
Eligibility Criteria
Inclusion Criteria
- 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/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
- Have a history of a seizure disorder.
Data sourced from ClinicalTrials.gov (NCT04524403). 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.