This Phase 2, Double Blind, Placebo-controlled, Randomized Study is to Assess the Safety and Efficacy of Miricorilant in Obese Adult With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications.

Antipsychotic-induced Weight Gain (AIWG) Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818256
• Other study ID #: CORT118335-876
• Status: Completed
• Phase: Phase 2
• Start date: October 31, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Corcept Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant in obese adult with schizophrenia treated with antipsychotic medications.

Description:

This is a randomized, double-blind, placebo-controlled study that will assess the safety, efficacy, and PK of miricorilant in obese patients with schizophrenia or bipolar disorder who are currently taking oral or injectable atypical antipsychotic medication. Patients who meet the criteria for the Study CORT118335-876 will be randomized on Day 1 to receive 600 mg miricorilant or placebo for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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/m2

Exclusion Criteria:

• Have a history of a medical condition affecting body weight (e.g., 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 hypotension
• Have a history of orthostatic hypotension

Related Conditions & MeSH terms

• Antipsychotic-induced Weight Gain (AIWG)
• Bipolar Disorder
• Schizophrenia
• Weight Gain

Intervention

Drug:
• Miricorilant
Miricorilant 600mg
• Miricorilant
Placebo tablets for once daily oral dosing

Locations

Country	Name	City	State
United States	Site 137	Bellevue	Washington
United States	Site 143	Bentonville	Arkansas
United States	Site 181	Chapel Hill	North Carolina
United States	Site 153	Culver City	California
United States	Site 107	Dayton	Ohio
United States	Site 206	DeSoto	Texas
United States	Site # 239	Garden Grove	California
United States	Site 138	Glen Burnie	Maryland
United States	Site 066	Houston	Texas
United States	Site 146	Kansas City	Kansas
United States	Site 151	Las Vegas	Nevada
United States	Site 134	Lemon Grove	California
United States	Site 140	Lincolnwood	Illinois
United States	Site 249	Little Rock	Arkansas
United States	Site 235	Media	Pennsylvania
United States	Site 202	Miami	Florida
United States	Site 216	New York	New York
United States	Site 144	North Miami	Florida
United States	Site 126	Oakland	California
United States	Site 163	Oceanside	California
United States	Site 241	Okeechobee	Florida
United States	Site 229	Rancho Cucamonga	California
United States	Site 165	Richardson	Texas
United States	Site 139	Salt Lake City	Utah
United States	Site 150	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Corcept Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in body weight at Week 12 for 600 mg miricorilant versus placebo		Baseline Day 1 to Week 12
Primary	Incidence of adverse events (AEs), serious AEs (SAEs), and AEs leading to early discontinuation		Up to Follow-up Visit (up to Week 16)
Secondary	Percentage of patients achieving more than or equal to 5% weight loss	Percentage of patients achieving more than or equal to 5% weight loss for 600 mg miricorilant versus placebo	Baseline Day 1 to week 12
Secondary	Change from baseline in Homeostatic model assessment for insulin resistance (HOMA-IR) at Week 12	Change in insulin resistance (HOMA-IR) for 600 mg miricorilant versus placebo	Baseline Day 1 to week 12
Secondary	Change from baseline in waist-to-hip ratio at Week 12	600 mg Miricorilant versus placebo	Baseline Day1 to week 12