miricorilant (CORT118335) / Corcept Therap - LARVOL DELTA

Study Evaluating the Bioavailability of Miricorilant With Optional Food Effect Assessment in Healthy Adult Subjects (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Corcept Therapeutics

New P1 trial

Metabolic Dysfunction-Associated Steatohepatitis (MASH) (Businesswire) - "MONARCH - Enrollment completed in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed or presumed MASH - Results expected by the end of next year."

Enrollment closed • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

MIRICORILANT, A SELECTIVE GLUCOCORTICOID RECEPTOR MODULATOR, REPROGRAMS HEPATIC GENE NETWORKS IN METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (AASLD 2025) - P2 | "MIRI selectively modulated key genes in pathways that regulate hepatic steatosis, metabolism, oxidative stress, inflammation, and fibrosis. These findings provide insights into MIRI's molecular mechanism of action, potentially informing future therapeutic strategies. The ongoing phase 2b MONARCH trial (NCT06108219) is further evaluating MIRI in patients with biopsy-confirmed or presumed noncirrhotic MASH."

Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • APOA5 • AURKB • CXCL13 • CXCL8 • GPX2 • HMGCS2 • KIF14 • KIF4A • KIFC1 • PCK2 • TOP2A

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH) (clinicaltrials.gov) - P2 | N=175 | Active, not recruiting | Sponsor: Corcept Therapeutics | Trial completion date: Jun 2026 ➔ Sep 2026 | Trial primary completion date: Jun 2026 ➔ Sep 2026

Trial completion date • Trial primary completion date • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Evaluation of the Pharmacokinetics, Disposition, and Metabolism of Miricorilant, a Novel Glucocorticoid Receptor Modulator for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis in Nonclinical and Clinical Studies. (PubMed, J Clin Pharmacol) - "In phase 1 clinical studies in healthy subjects, miricorilant showed an approximately dose-proportional increase in systemic exposure in the dose range 100-900 mg with an elimination half-life of ≈20 h. In clinical DDI studies at the total plasma concentrations evaluated, miricorilant was a strong inhibitor of CYP2C8 and a moderate inhibitor of BCRP with no meaningful inhibition of CYP2C9, CYP3A4, or UGT1A1, and a moderately sensitive substrate of CYP2C19. Miricorilant was safe and well-tolerated in the phase 1 studies."

Journal • PK/PD data • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • CYP1A2 • CYP2C19 • CYP2C9 • CYP3A4 • UGT1A1

The Effect of Glucocorticoid and Mineralocorticoid Receptor Antagonists in the Skin of Aged Female Mice. (PubMed, Int J Mol Sci) - "Mice were treated with selective GR (relacorilant), selective MR (eplerenone), or dual GR/MR (miricorilant) antagonists for 8 weeks. The results contrast with data from GR/MR knockout studies, highlighting the likely significance of receptor dynamics. Further studies of antagonist effects on receptor interactions with co-regulators appear warranted."

Journal • Preclinical • Dermatology • Inflammation • COL3A1

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH) (clinicaltrials.gov) - P2 | N=195 | Active, not recruiting | Sponsor: Corcept Therapeutics | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2025 ➔ Jun 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment closed • Trial completion date • Trial primary completion date • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Evaluation of Miricorilant on Liver Fat in Patients With MASLD (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Corcept Therapeutics | Not yet recruiting ➔ Recruiting | Trial completion date: Sep 2025 ➔ Mar 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Enrollment open • Trial completion date • Trial primary completion date • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Study testing fatty liver disease MASH therapy almost fully enrolled (Liver Disease News) - "Enrollment is nearly complete in a Phase 2b clinical trial that’s testing Corcept Therapeutics‘ experimental oral therapy miricorilant in people with metabolic-associated steatohepatitis (MASH), a severe form of fatty liver disease....MONARCH (NCT06108219) is expected to enroll nearly 200 adults at sites across the U.S., including Puerto Rico. Initial results are expected late next year."

Enrollment status • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Molecular Profiling of the Selective Glucocorticoid Receptor Modulators CORT118335 (Miricorilant) and CORT125385 With Lipid-Lowering Properties in the Liver (ENDO 2025) - "Mice were subsequently treated with vehicle, the GR agonist corticosterone (3 mg/kg/day), the GR antagonist mifepristone, CORT118335 or CORT125385 (all 60 mg/kg/day) for three days...GO-term analysis on gene subsets after applying molecular filters suggested that the lipid-lowering effects of SGRMs likely involve corticosterone-like upregulation and SGRM-specific downregulation of genes. We tentatively conclude that CORT118335- and CORT125385-induced GR modulation results in a unique transcriptional profile, thereby lowering hepatic lipid levels."

Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

CORCEPT THERAPEUTICS ANNOUNCES FIRST QUARTER FINANCIAL RESULTS AND PROVIDES CORPORATE UPDATE (Businesswire) - "Clinical Development:...(i) Amyotrophic Lateral Sclerosis (ALS):...DAZALS - Results to be presented at European Network to Cure ALS (ENCALS) annual meeting in June 2025...; (ii) Metabolic Dysfunction-Associated Steatohepatitis (MASH): MONARCH – Enrollment continues in randomized, double-blind, placebo-controlled, Phase 2b trial of miricorilant in patients with biopsy-confirmed or presumed MASH....'We look forward to building on these promising results in our MONARCH study. First results are expected by the end of next year'..."

P2 data • Amyotrophic Lateral Sclerosis • Metabolic Dysfunction-Associated Steatohepatitis

Evaluation of Miricorilant on Liver Fat in Patients With MASLD (clinicaltrials.gov) - P1 | N=8 | Not yet recruiting | Sponsor: Corcept Therapeutics

New P1 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Effect of hepatic impairment on the pharmacokinetics of Miricorilant: results from a phase 1, open-label, adaptive-design study (EASL 2025) - P1, P2 | "Miricorilant 600 mg was generally well tolerated in pts with moderate and severe hepatic impairment and in matched healthy volunteers. Hepatic impairment had minimal impact on the systemic plasma exposures (as measured by AUC) of miricorilant. These findings support future inclusion of pts with compensated cirrhotic (F4) MASH in the miricorilant clinical development program."

Clinical • P1 data • PK/PD data • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant (clinicaltrials.gov) - P1 | N=19 | Completed | Sponsor: Corcept Therapeutics | Recruiting ➔ Completed | N=36 ➔ 19 | Trial completion date: Dec 2024 ➔ Sep 2024 | Trial primary completion date: Dec 2024 ➔ Sep 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

METABOLOMIC AND LIPIDOMIC ANALYSIS OF PATIENTS WITH PRESUMED METABOLIC DYSFUNCTION-ASSOCIATED STEATOHEPATITIS (MASH) TREATED WITH THE SELECTIVE GLUCOCORTICOID RECEPTOR MODULATOR MIRICORILANT (AASLD 2024) - P1, P2 | "This study highlights the potential of MIRI as a MASH treatment and suggests that pts who respond to MIRI, especially those with rapid LFC reduction and efficacy-associated rise in ALT (RRs), had a significant enhancement in metabolic clearance of FAs. The changes may indicate an increase in cellular FA beta-oxidation, which, despite contributing to transient hepatic stress in some pts, signals improved metabolic regulation and liver health. The ongoing MONARCH phase 2b trial (NCT06108219) will provide further insights into MIRI's efficacy."

Clinical • Omic analysis • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

The glucocorticoid receptor antagonist miricorilant decreases alcohol self-administration in alcohol-dependent female rats (Neuroscience 2024) - "CORT118335 selectively reduced irritability in alcohol-dependent female rats. These findings indicate the potential of CORT118335 as a novel treatment for AUD."

Preclinical • Addiction (Opioid and Alcohol) • CNS Disorders • PGR

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P1 | N=70 | Completed | Sponsor: Corcept Therapeutics | Recruiting ➔ Completed | Phase classification: P1b ➔ P1 | Trial completion date: Aug 2024 ➔ Jan 2024 | Trial primary completion date: Aug 2024 ➔ Jan 2024

Phase classification • Trial completion • Trial completion date • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

A Sub Study of the Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Miricorilant in Patients With Presumed Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P=N/A | N=22 | Completed | Sponsor: Corcept Therapeutics | Active, not recruiting ➔ Completed

Trial completion • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH) (clinicaltrials.gov) - P2 | N=195 | Recruiting | Sponsor: Corcept Therapeutics | N=150 ➔ 195

Enrollment change • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Pharmacokinetics of the selective glucocorticoid receptor modulator miricorilant in healthy volunteers and patients with presumed metabolic dysfunction-associated steatohepatitis (MASH) (EASL-ILC 2024) - P1, P1b, P2 | "The presented studies characterize the PK/ADME of MIRI in HVs and pts with MASH. A phase 2b study (MONARCH, NCT06108219) of MIRI 100 mg twice weekly in MASH is underway."

Clinical • PK/PD data • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Characterization of Clinical Candidate Miricorilant in Preclinical Models for NASH (ENDO 2024) - "PCLS were cultured for a total of 168 hours in the presence of 100 nM hydrocortisone, and with or without an exogenous lipid challenge. Miricorilant rapidly and effectively lowers hepatic lipid content in the mouse liver and in human PCLS, possibly via modulation of VLDL remodeling.Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. Abstracts presented at a news conference are embargoed until the date and time of the news conference."

Preclinical • Addiction (Opioid and Alcohol) • Dyslipidemia • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Corcept Therapeutics | Trial completion date: Mar 2024 ➔ Dec 2024 | Trial primary completion date: Mar 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

MOLECULAR AND FUNCTIONAL CHARACTERIZATION OF CLINICAL CANDIDATE MIRICORILANT, A SELECTIVE GR MODULATOR, IN PRECLINICAL MODELS FOR NASH (ICE-EDEC 2024) - "Precision-cut liver slices (PCLS) were generated from human liver tissue with pre-existing steatosis and cultured for a total of 168 hours in the presence of 100 nM hydrocortisone. Miricorilant rapidly and effectively lowers hepatic lipid content in a mouse model for NASH and in a human PCLS model."

Preclinical • Addiction (Opioid and Alcohol) • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis (MONARCH) (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Corcept Therapeutics

Trial completion date • Trial primary completion date • Hepatology • Metabolic Disorders • Non-alcoholic Steatohepatitis

A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis (MONARCH) (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Corcept Therapeutics | Phase classification: P2b ➔ P2

Phase classification • Hepatology • Metabolic Disorders • Non-alcoholic Steatohepatitis