MedTrace Logo

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)

NCT04524403 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2024-06-13

Study results available
· View outcomes & findings →

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.

Conditions

  • Antipsychotic-induced Weight Gain (AIWG)

Interventions

DRUG

Miricorlilant

Miricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing

DRUG

Miricorlilant

Miricorilant 900 mg (6 X 150 mg) for once-daily for oral dosing

DRUG

Placebo

Placebo for once-daily oral dosing

Sponsors & Collaborators

  • Corcept Therapeutics

    lead INDUSTRY

Principal Investigators

  • Kavita Juneja, MD · Corcept Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-09
Primary Completion
2022-07-29
Completion
2022-08-25
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04524403 on ClinicalTrials.gov