12 completed, 1 terminated. 8 Phase 1, 5 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 8 | Completed 8 |
| Phase 2 | 5 | Completed 4, Terminated 1 |
Follow CORT118335: new trials by email Literature Review of CORT118335 trials Research Report on CORT118335
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects Miricorilant Treatment A, Miricorilant Treatment B, Miricorilant Treatment C - Healthy | Phase 1 | Completed | Corcept Therapeutics | 18 | 2025-09-11 | 2026-04-13 |
| A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH) Miricorilant (Cohort A), Placebo (Cohort A), Miricorilant (Cohort B) - Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-associated Steatohepatitis (MASH) | Phase 2 | Completed | Corcept Therapeutics | 175 | 2023-10-25 | 2026-09-29 |
| Study to Evaluate the Effects of a Cytochrome P450 2C19 Inhibitor on the Pharmacokinetics of Miricorilant Miricorilant, Fluvoxamine - Antipsychotic Induced Weight Gain, Non-alcoholic Steatohepatitis (NASH) | Phase 1 | Completed | Corcept Therapeutics | 26 | 2023-01-24 | 2023-03-22 |
| Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant Miricorilant - Non-alcoholic Steatohepatitis (NASH) | Phase 1 | Completed | Corcept Therapeutics | 19 | 2022-03-03 | 2025-03-30 |
| A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH) Miricorilant 150 mg, Miricorilant 100 mg, Miricorilant 50 mg - Nonalcoholic Steatohepatitis (NASH) | Phase 1 | Completed | Corcept Therapeutics | 70 | 2021-11-23 | 2024-08-19 |
| Medication Development for Protracted Abstinence in Alcoholism: CORT118335 Versus Placebo Miricorilant, Placebo oral tablet - Alcohol Use Disorder | Phase 2 | Completed | The Scripps Research Institute | 50 | 2021-04-15 | 2023-02-03 |
| Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Participants With Presumed Nonalcoholic Steatohepatitis (NASH) Miricorilant, Placebo - Nonalcoholic Steatohepatitis (NASH) | Phase 2 | Terminated | Corcept Therapeutics | 12 | 2020-11-04 | 2022-08-31 |
| A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Obese Adult Patients With Schizophrenia While Taking Antipsychotic Medications (GRATITUDE II) Miricorlilant, Placebo - Antipsychotic-induced Weight Gain (AIWG) | Phase 2 | Completed | Corcept Therapeutics | 150 | 2020-09-09 | 2024-06-13 |
| Single and Multiple Dose Study of Miricorilant (CORT118335) Tablet Formulations in Healthy Participants Miricorilant 300 mg tablets, Miricorilant 150 mg tablets, Placebo 150 mg tablets - Healthy | Phase 1 | Completed | Corcept Therapeutics | 36 | 2020-04-27 | 2020-12-17 |
| A Study to Assess the Safety, Efficacy, and Pharmacokinetics of Miricorilant (CORT118335) in Obese Adults With Schizophrenia or Bipolar Disorder Treated With Antipsychotic Medications Miricorilant, Placebo - Antipsychotic-induced Weight Gain (AIWG) | Phase 2 | Completed | Corcept Therapeutics | 71 | 2019-12-04 | 2024-09-19 |
| The Effect of CORT118335 on Olanzapine-Induced Weight Gain Olanzapine, CORT118335, Placebo - Antipsychotic-induced Weight Gain | Phase 1 | Completed | Corcept Therapeutics | 96 | 2019-04-01 | 2020-04-28 |
| Absolute Bioavailability and Metabolism Study of CORT118335 in Healthy Male Participants CORT118335 Oral, 14C-CORT118335 intravenous, 14C-CORT118335 oral - Healthy | Phase 1 | Completed | Corcept Therapeutics | 12 | 2018-08-06 | 2019-06-11 |
| First-in-human Study in Healthy Subjects CORT118335, 25 mg, Prednisone Oral Tablet, Glucose - Healthy | Phase 1 | Completed | Corcept Therapeutics | 143 | 2017-09-15 | 2019-05-24 |
Non-alcoholic Fatty Liver Disease (5) · Mental Disorders (2) · Obesity (2) · Schizophrenia (2) · Weight Gain (2) · Alcohol-Related Disorders (1) · Alcoholism (1) · Bipolar Disorder (1)
Corcept Therapeutics (12) · The Scripps Research Institute (1)
United States (9) · United Kingdom (4) · India (1) · Puerto Rico (1)
Kavita Juneja, MD (4) · Joseph Custodio, PhD (3) · Sharan Sidhu, MBChB, BAO, MRCS, MFPM (3) · Barbara J. Mason, Ph.D. (1) · Stuart Mair, MBChB, MFPM (1)
2019 (2), 2018 (1), U01AA025476 (1)