ASC41 / Ascletis - LARVOL DELTA

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH (clinicaltrials.gov) - P2 | N=183 | Active, not recruiting | Sponsor: Gannex Pharma Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Gannex Pharma Co., Ltd. | Phase classification: P2a/2b ➔ P2

Phase classification • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

ASC41, a selective THRβ agonist significantly reduces liver fat and ALT in biopsy-confirmed MASH patients after 12-week treatment: an interim analysis of a 52-week serial liver biopsy study (EASL-ILC 2024) - P2 | "Significant reductions in Liver fat, ALT, AST and lipids at week 12 warrant further clinical studies for ASC41 tablet."

Biopsy • Clinical • Fibrosis • Hepatology • Immunology • Inflammation • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Gannex Announces Poster Presentation of Positive Interim 12-Week Results from Phase II Clinical Trial of ASC41 in Patients with Biopsy-Confirmed MASH at EASL CONGRESS 2024 (PRNewswire) - P2 | N=180 | NCT05462353 | Sponsor: Gannex Pharma Co., Ltd. | "Gannex Pharma...announced a poster presentation at the...EASL Congress 2024....The poster presentation...describes significant and clinically meaningful reductions in liver fat, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) in biopsy-confirmed MASH patients receiving 12-week treatment of ASC41 tablet, among which the data of ALT and AST notably differentiates ASC41 from other thyroid hormone receptor β (THRβ) agonists currently at clinical or commercial stages. In addition, baseline characteristics from Phase II clinical trials were comparable between ASC41, conducted in China, and resmetirom, except for lower body mass index (BMI) and more males for ASC41....'93.3% of patients receiving treatment with ASC41 experienced at least 30% relative reduction from baseline in liver fat content as assessed by magnetic resonance imaging, proton density fat fraction (MRI-PDFF)'..."

P2 data • Metabolic Dysfunction-Associated Steatohepatitis

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Gannex Pharma Co., Ltd. | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: May 2024 ➔ May 2025

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

Gannex Announces Positive Interim Results from 52-Week Phase II Clinical Trial of Once-Daily ASC41 Tablet in Patients with Biopsy-Confirmed Non-alcoholic Steatohepatitis (PRNewswire) - P2 | N=180 | NCT05462353 | Sponsor: Gannex Pharma Co., Ltd. | Gannex Pharma Co., Ltd...announces today positive interim results from the 52-week Phase II clinical trial of thyroid hormone receptor β (THRβ) agonist ASC41 tablet for treatment of patients with biopsy-confirmed non-alcoholic steatohepatitis (NASH)....Mean alanine aminotransferase (ALT) and aspartate aminotransferase (AST) at baseline ranged from 65.9 to 84.8 U/L and 44.2 to 53.8 U/L, respectively, across ASC41 tablet and placebo cohorts....Consistent with prior studies, patients receiving ASC41 tablet treatment demonstrated statistically significant and clinical meaningful placebo-adjusted mean reductions from baseline in low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) and triglyceride (TG) up to 27.7%, 23.4% and 46.5%, respectively..."

P2 data • Cardiovascular • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH (clinicaltrials.gov) - P2a/2b | N=0 | Withdrawn | Sponsor: Gannex Pharma Co., Ltd. | N=180 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Hepatology • Non-alcoholic Steatohepatitis

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH (clinicaltrials.gov) - P2a/2b | N=180 | Not yet recruiting | Sponsor: Gannex Pharma Co., Ltd. | Trial completion date: Jan 2024 ➔ Jan 2025 | Trial primary completion date: Nov 2023 ➔ Nov 2024

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

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Gannex Pharma Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 Tablets in Adult Patients With NASH (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Gannex Pharma Co., Ltd.

New P2 trial • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH (clinicaltrials.gov) - P2a/2b | N=180 | Not yet recruiting | Sponsor: Gannex Pharma Co., Ltd. | Initiation date: Mar 2022 ➔ Dec 2022

Trial initiation date • Hepatology • Non-alcoholic Steatohepatitis

Study to Evaluate the Safety, Tolerability, and Efficacy of ASC41 in Adults With NASH (clinicaltrials.gov) - P2a/2b; N=180; Not yet recruiting; Sponsor: Gannex Pharma Co., Ltd.; Initiation date: Dec 2021 ➔ Mar 2022

Clinical • Trial initiation date • Hepatology • Non-alcoholic Steatohepatitis • MRI

Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects (clinicaltrials.gov) - P1; N=8; Recruiting; Sponsor: Gannex Pharma Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Safety, Tolerability, and Pharmacokinetics of ASC43F, a Fixed Dose Combination Tablet in Healthy Subjects (clinicaltrials.gov) - P1; N=8; Not yet recruiting; Sponsor: Gannex Pharma Co., Ltd.

Clinical • New P1 trial

[VIRTUAL] A PHASE IB STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PHARMACODYNAMICS OF ASC41, A THR-Β AGONIST, FOR 28-DAYS IN OVERWEIGHT AND OBESE SUBJECTS WITH ELEVATED LDL-C, A POPULATION CHARACTERISTIC OF NAFLD (AASLD 2021) - P1 | "These data support advancement of the ASC41 clinical program for the indication of NASH . The successful development of commercially-ready oral tablet formulation will accelerate ASC41 clinical development ."

Clinical • P1 data • PK/PD data • Dyslipidemia • Hepatology • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • Obesity • CYP3A4

[VIRTUAL] ASC43F TABLET AS A ONE-PILL, ONCE-A-DAY FIXED-DOSE COMBINATION (FDC) OF ASC41, A THR-Β AGONIST, AND ASC42, AN FXR AGONIST, DEMONSTRATED COMPARABLE DISSOLUTION PROFILES AND IN VIVO PHARMACOKINETICS VS. SINGLE ASC41 AND ASC42 TABLET (AASLD 2021) - "ASC43F is a One-Pill, Once-a-Day FDC of THR-β agonist and FXR agonist for NASH treatment and will improve patient compliance ."

PK/PD data • Preclinical • Dermatology • Hepatology • Non-alcoholic Steatohepatitis • Pruritus • FGF19

A Study of the Relative Bioavailability of ASC41 in Healthy Subjects (clinicaltrials.gov) - P1; N=60; Completed; Sponsor: Ascletis Pharmaceuticals Co., Ltd.; Recruiting ➔ Completed; Trial completion date: Aug 2022 ➔ Dec 2020; Trial primary completion date: Jul 2021 ➔ Dec 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date

DDI Study of ASC41 Tablets in HV and the PK, Safety and Tolerability in Subjects With NAFLD. (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: Gannex Pharma Co., Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Hepatology • Non-alcoholic Fatty Liver Disease

[VIRTUAL] Significant Improvement of NAFLD Activity Scores and Liver Fibrosis by ASC41, a Selective THR-β Agonist, in HIgh Fat Diet Induced NASH SD Rats (EASL-ILC 2021) - "50 male rats with STZ and DEN injections were selected and randomly divided into 5 groups as model+vehicle group, comparator group (MGL3196 5 mg/kg), ACS41 0.5 mg/kg, ACS41 1.5 mg/kg, ACS41 4.5 mg/k. ASC41 demonstrated NAS reductions and anti-fibrotic benefits in the HFD+DEN+STZ rat NASH Model. The current efficacy data supported the advancement of ASC41 into clinical trials in human."

Preclinical • Addiction (Opioid and Alcohol) • Diabetes • Dyslipidemia • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Non-alcoholic Fatty Liver Disease • Non-alcoholic Steatohepatitis • CYP3A4

DDI Study of ASC41 Tablets in HV and the PK, Safety and Tolerability in Subjects With NAFLD. (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: Gannex Pharma Co., Ltd.

New P1 trial • Hepatology • Non-alcoholic Fatty Liver Disease

Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects (clinicaltrials.gov) - P1; N=20; Completed; Sponsor: Gannex Pharma Co., Ltd.; Enrolling by invitation ➔ Completed; Trial completion date: Jan 2022 ➔ Feb 2021

Biomarker • Clinical • Trial completion • Trial completion date • Dyslipidemia • Genetic Disorders • Hepatology • Non-alcoholic Fatty Liver Disease • Obesity

A Study of the Relative Bioavailability of ASC41 in Healthy Subjects (clinicaltrials.gov) - P1; N=65; Recruiting; Sponsor: Ascletis Pharmaceuticals Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open