Trials Sponsors Conditions Drugs Pricing

Conditions

Antipsychotic-induced Weight Gain (AIWG)

Keywords

Antipsychotic-induced weight gain (AIWG)ObesityWeight GainMental disordersSchizophreniaRisperidonePaliperidoneQuetiapineOlanzapine

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.

Interventions

MiricorlilantDrug

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

Also known as: CORT118335

Miricorlilant 600 mg

MiricorlilantDrug

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

Also known as: CORT118335

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Corcept Therapeutics
Industrylead

Study Sites (40)

Site #143

Bentonville, Arkansas, 72712, United States

Site # 249

Little Rock, Arkansas, 72211, United States

Site #153

Culver City, California, 90230, United States

Site #239

Garden Grove, California, 92845, United States

Site # 243

Glendale, California, 91206, United States

Site #134

Lemon Grove, California, 91945, United States

Site #163

Oceanside, California, 92056, United States

MeSH Terms

Conditions

ObesityWeight GainMental DisordersSchizophrenia

Interventions

CORT118335

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesSchizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

Title: Medical Director
Organization: Corcept Therapeutics Incorporated

Study Officials

Kavita Juneja, MD
Corcept Therapeutics
STUDY DIRECTOR

Publication Agreements

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

Enrollment

150 participants (actual enrollment reported by the registry).

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

Actual (reported)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (3)

Other Outcomes (3)

Study Arms (3)

Miricorlilant 600 mg

Miricorlilant 900 mg

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (40)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Documents

Locations