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

NCT04524403 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: CORT118335-877
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 40

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 patients with schizophrenia treated with antipsychotic medications.

Conditions

Antipsychotic-induced Weight Gain (AIWG)

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Body Weight

  Baseline Day 1 and Week 26

Secondary Outcomes (3)

• Change From Baseline in Body Weight for Both Dose Levels of Miricorilant Combined Versus Placebo

  Baseline Day 1 and Week 26

• Percentage of Patients Achieving a ≥5% Weight Loss for Miricorilant Versus Placebo

  Baseline Day 1 to Week 26

• Change From Baseline in Waist-to-hip Ratio for Miricorilant Versus Placebo

  Baseline Day 1 and Week 26

Other Outcomes (3)

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

  Baseline Day 1 to Week 30

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

  Baseline Day 1 to Week 30

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

  Baseline Day 1 to Week 30

Study Arms (3)

Miricorlilant 600 mg

EXPERIMENTAL

Patients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.

Drug: Miricorlilant

Miricorlilant 900 mg

EXPERIMENTAL

Patients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.

Drug: Miricorlilant

Placebo

PLACEBO COMPARATOR

Patients who meet the entry criteria will be randomized to receive placebo for 26 weeks.

Drug: Placebo

Interventions

Miricorlilant DRUG

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

Also known as: CORT118335

Miricorlilant 600 mg

Placebo DRUG

Placebo 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
• Are currently taking olanzapine, risperidone, paliperidone, or quetiapine and have gained weight from treatment while on these medications
• Must be on a stable dose of medication for 1 month prior to Screening
• 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
• Have a history of a seizure disorder.

Sponsors & Collaborators

• Corcept Therapeutics: lead

Study Sites (40)

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 # 243

Glendale, California, 91206, United States

Location

Site #134

Lemon Grove, California, 91945, United States

Location

Site #163

Oceanside, California, 92056, United States

Location

Site # 247

Pico Rivera, California, 90660, United States

Location

Site # 229

Rancho Cucamonga, California, 91730, United States

Location

Site # 237

San Diego, California, 92103, United States

Location

Site # 150

Stanford, California, 94305, United States

Location

Site #202

Miami, Florida, 33122, United States

Location

Site #144

Miami Lakes, Florida, 33016, United States

Location

Site #144

North Miami, Florida, 33161, United States

Location

Site #241

Okeechobee, Florida, 34972, United States

Location

Site # 240

Chicago, Illinois, 60640, United States

Location

Site #140

Chicago, Illinois, 60641, United States

Location

Site #140

Lincolnwood, Illinois, 60712, United States

Location

Site #225

Flowood, Mississippi, 39232, United States

Location

Site #224

St Louis, Missouri, 63125, United States

Location

Site #217

Lincoln, Nebraska, 68526, United States

Location

Site #151

Las Vegas, Nevada, 89102, United States

Location

Site # 244

Cedarhurst, New York, 11516, United States

Location

Site #216

New York, New York, 10032, United States

Location

Site # 245

New York, New York, 10036, United States

Location

Site #231

Staten Island, New York, 10312, United States

Location

Site #231

Staten Island, New York, 10314, United States

Location

Site # 248

Charlotte, North Carolina, 28211, 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 # 230

North Canton, Ohio, 44720, United States

Location

Site #166

Philadelphia, Pennsylvania, 19125, United States

Location

Site #235

Thorndale, Pennsylvania, 19372, United States

Location

Site #235

West Chester, Pennsylvania, 19380, United States

Location

Site #223

Austin, Texas, 78754, 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 #137

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Conditions

Obesity; Weight Gain; Mental Disorders; Schizophrenia

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

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: August 6, 2020
• First Posted: August 24, 2020
• Study Start: September 9, 2020
• Primary Completion: July 29, 2022
• Study Completion: August 25, 2022
• Last Updated: June 13, 2024
• Results First Posted: June 13, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (40)