At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 71 enrolled
Drug / intervention
Miricorilant +1 moredrug
Likely dose
Miricorilant 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 (CORT118335) in Obese Adult Patients With Schizophrenia or Bipolar Disorder and Recent Weight Gain While Taking Antipsychotic Medications (GRATITUDE)
In Brief
A Phase 2 clinical trial evaluating Miricorilant and Placebo for Antipsychotic-induced Weight Gain (AIWG). Completed, enrolled 71 participants across 27 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 adults with schizophrenia or bipolar disorder treated with antipsychotic medications.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAntipsychotic-induced Weight Gain (AIWG)
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartDec 2019
Primary CompletionJun 2022
Study CompletionJul 2022
TodayJul 2026
First PostedJan 28, 2019
Enrollment StartDec 4, 2019
Primary CompletionJun 17, 2022
Study CompletionJul 6, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 7.4 years ago
Interventions
Miricorilantdrug
Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing
Placebodrug
Placebo tablets for once-daily oral dosing