At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 150 enrolled
Drug / intervention
Miricorlilant +2 moredrug
Likely dose
Miricorlilant 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia Taking Antipsychotic Medications (GRATITUDE II)
In Brief
A Phase 2 clinical trial evaluating Miricorlilant and Placebo for Antipsychotic-induced Weight Gain (AIWG). Completed, enrolled 150 participants across 40 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAntipsychotic-induced Weight Gain (AIWG)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
202120222023202420252026
First PostedAug 2020
Enrollment StartSep 2020
Primary CompletionJul 2022
Study CompletionAug 2022
TodayJul 2026
First PostedAug 24, 2020
Enrollment StartSep 9, 2020
Primary CompletionJul 29, 2022
Study CompletionAug 25, 2022
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.9 years ago
Interventions
Miricorlilantdrug
Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
Miricorlilantdrug
Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing
Placebodrug
Placebo for once-daily oral dosing