A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications

NCT03818256 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CORT118335-876
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 27

Brief 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.

Conditions

Antipsychotic-induced Weight Gain (AIWG)

Keywords

Antipsychotic-induced weight gain (AIWG); Obesity; Weight Gain; Mental disorders; Schizophrenia; Risperidone; Quetiapine; Olanzapine; Bipolar Disorder

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Body Weight at Week 12 for 600 mg Miricorilant Versus Placebo

  Baseline Day 1 and Week 12

• Number of Patients With One or More Treatment-emergent Adverse Events

  Up to Follow-up Visit (Week 16)

• Number of Patients With One or More Treatment-emergent Serious Adverse Events

  Up to Follow-up Visit (up to Week 16)

• Number of Patients With One or More Treatment-emergent Adverse Events Leading to Early Study Discontinuation

  Up to Follow-up Visit (up to Week 16)

Secondary Outcomes (3)

• Percentage of Patients Achieving More Than or Equal to 5% Weight Loss

  Baseline Day 1 to Week 12

• Change From Baseline in HOMA-IR at Week 12

  Baseline Day 1 and Week 12

• Change From Baseline in Waist-to-hip Ratio at Week 12

  Baseline Day 1 and Week 12

Study Arms (2)

Miricorilant 600 mg

EXPERIMENTAL

Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 12 weeks.

Drug: Miricorilant

Placebo

PLACEBO COMPARATOR

Patients who meet the entry criteria will be randomized to receive placebo for 12 weeks.

Drug: Placebo

Interventions

Miricorilant DRUG

Miricorilant 600 mg (6 X 100 mg tablets) for once-daily oral dosing

Also known as: CORT118335

Miricorilant 600 mg

Placebo DRUG

Placebo tablets for once-daily oral dosing

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m\^2.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (27)

Site 143

Bentonville, Arkansas, 72712, United States

Location

Site 249

Little Rock, Arkansas, 72211, United States

Location

Site 153

Culver City, California, 90230, United States

Location

Site 239

Garden Grove, California, 92845, United States

Location

Site 134

Lemon Grove, California, 91945, United States

Location

Site 126

Oakland, California, 94607, United States

Location

Site 163

Oceanside, California, 92056, United States

Location

Site 229

Rancho Cucamonga, California, 91730, United States

Location

Site 202

Miami, Florida, 33122, United States

Location

Site 144

North Miami, Florida, 33161, United States

Location

Site 241

Okeechobee, Florida, 34972, United States

Location

Site 140

Chicago, Illinois, 60641, United States

Location

Site 140

Lincolnwood, Illinois, 60712, United States

Location

Site 146

Wichita, Kansas, 67214, United States

Location

Site 138

Glen Burnie, Maryland, 20161, United States

Location

Site 151

Las Vegas, Nevada, 89102, United States

Location

Site 216

New York, New York, 10032, United States

Location

Site 181

Raleigh, North Carolina, 27608, United States

Location

Site 181

Raleigh, North Carolina, 27610, United States

Location

Site 107

Dayton, Ohio, 45417, United States

Location

Site 235

Thorndale, Pennsylvania, 19372, United States

Location

Site 235

West Chester, Pennsylvania, 19380, United States

Location

Site 206

DeSoto, Texas, 75115, United States

Location

Site 066

Houston, Texas, 77030, United States

Location

Site 165

Richardson, Texas, 75080, United States

Location

Site 139

Salt Lake City, Utah, 84105, United States

Location

Site 137

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Obesity; Weight Gain; Mental Disorders; Schizophrenia; Bipolar Disorder

Interventions

CORT118335

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Schizophrenia Spectrum and Other Psychotic Disorders; Bipolar and Related Disorders; Mood Disorders

Results Point of Contact

• Title: Medical Director
• Organization: Corcept Therapeutics Incorporated

info@corcept.com

650-327-3270

Study Officials

• Kavita Juneja, MD

  Corcept Therapeutics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: December 4, 2019
• Primary Completion: June 17, 2022
• Study Completion: July 6, 2022
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)