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Miricorlilant

Phase 2

Antipsychotic-induced Weight Gain (AIWG) | Small molecule | Psychiatry |Corcept Therapeutics Incorporated|Last Updated: Jun 13, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

Clinical trial landscape

Miricorlilant · 1 trial · 1 indication

Phase 2 1
NCT04524403A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)Antipsychotic-induced Weight Gain (AIWG)
COMPLETED150 Analytics
PHASE2COMPLETED
A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II)
Antipsychotic-induced Weight Gain (AIWG)Unlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Body Weight
Baseline Day 1 and Week 26

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Miricorlilant 600 mgEXPERIMENTALPatients who meet the entry criteria will be randomized to receive 600 mg miricorilant for 26 weeks.
Miricorlilant 900 mgEXPERIMENTALPatients who meet the entry criteria will be randomized to receive 900 mg miricorilant for 26 weeks.
PlaceboPLACEBO_COMPARATORPatients who meet the entry criteria will be randomized to receive placebo for 26 weeks.

Interventions

NameTypeDescription
MiricorlilantDRUGMiricorilant 600 mg (4 X 150 mg) for once-daily for oral dosing
PlaceboDRUGPlacebo for once-daily oral dosing
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites40

Inclusion Criteria: * 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. Exc...

Countries:United States
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Frequently asked questions about Miricorlilant

What is Miricorilant used for?

Miricorilant is an investigational small molecule being developed for antipsychotic-induced weight gain (AIWG), a condition that can occur in patients taking antipsychotic medications. It is being studied in the psychiatry therapeutic area for this indication.

Who makes Miricorilant?

Miricorilant is being developed by Corcept Therapeutics Incorporated, a biopharmaceutical company traded on NASDAQ under the ticker CORT. The company is conducting clinical research to evaluate the drug's safety and efficacy for antipsychotic-induced weight gain.

What phase is Miricorilant in?

Miricorilant is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for its potential to address antipsychotic-induced weight gain in patients.

What clinical trials is Miricorilant in?

Miricorilant has been evaluated in a Phase 2 clinical trial with the identifier NCT04524403, known as the GRATITUDE II study. This randomized, double-blind, placebo-controlled trial enrolled 150 obese adult patients with schizophrenia who were taking antipsychotic medications. The study was conducted in the United States and has been completed.

Is Miricorilant the same as GRATITUDE II?

No, Miricorilant is the drug being studied, while GRATITUDE II is the name of the clinical trial evaluating it. The trial, identified as NCT04524403, assessed the safety, efficacy, and pharmacokinetics of Miricorilant in patients with antipsychotic-induced weight gain.