CLINICAL TRIALS PROFILE FOR CORT118335

Clinical Trials for CORT118335

Trial ID	Title	Status	Sponsor	Phase	Summary
NCT03315338 ↗	First-in-human Study in Healthy Subjects	Completed	Corcept Therapeutics	Phase 1	This initial Phase I study will evaluate the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of CORT118335, the effect of concomitant administration with food on exposure to CORT118335, and its pharmacological effect in healthy subjects.
NCT03818256 ↗	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.	Recruiting	Corcept Therapeutics	Phase 2	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.
NCT03823703 ↗	Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH)	Terminated	Corcept Therapeutics	Phase 2	This phase 2, double blind, placebo-controlled, randomized study is to assess the safety and efficacy of miricorilant (CORT118335) in patients with presumed Nonalcoholic Steatohepatitis (NASH).
NCT03877562 ↗	The Effect of CORT118335 on Olanzapine-Induced Weight Gain	Completed	Corcept Therapeutics	Phase 1	This study will investigate if there is any difference in the amount of weight gained by participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy test medicine which looks like CORT118335 but contains no active medicine). Safety and tolerability of CORT118335 when taken with olanzapine will also be evaluated.
NCT03878264 ↗	Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants	Completed	Corcept Therapeutics	Phase 1	This study will evaluate the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures following a single oral dose of CORT118335 in healthy male participants.
NCT04466215 ↗	Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo	Recruiting	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	The hypotheses under test are that subjects with alcohol use disorder (AUD) of moderate or greater severity treated with CORT118335 will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.

Clinical Trial Conditions for CORT118335

Condition Name

Condition Name
Intervention	Trials
Healthy	3
Nonalcoholic Steatohepatitis (NASH)	3
Antipsychotic-induced Weight Gain (AIWG)	2
Metabolic Dysfunction-associated Steatohepatitis (MASH)	1

Condition MeSH

Condition MeSH
Intervention	Trials
Non-alcoholic Fatty Liver Disease	5
Fatty Liver	5
Weight Gain	4
Schizophrenia	2

Clinical Trial Locations for CORT118335

Trials by Country

Trials by Country
Location	Trials
United States	61
United Kingdom	4
Puerto Rico	1

Trials by US State

Trials by US State
Location	Trials
Florida	7
Texas	5
California	5
Washington	4
New York	4

Clinical Trial Progress for CORT118335

Clinical Trial Phase

Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	5
Phase 1	7

Clinical Trial Status

Clinical Trial Status
Clinical Trial Phase	Trials
Recruiting	6
Completed	4
Not yet recruiting	1

Clinical Trial Sponsors for CORT118335

Sponsor Name

Sponsor Name
Sponsor	Trials
Corcept Therapeutics	11
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	1
The Scripps Research Institute	1

Sponsor Type

Sponsor Type
Sponsor	Trials
Industry	11
NIH	1
Other	1