HSK31679 / Haisco - LARVOL DELTA

Efficacy and Safety of HSK31679 in Asian Patients with MASLD: A Randomized Controlled Trial. (PubMed, Clin Gastroenterol Hepatol) - P2 | "In Asian MASLD patients, HSK31679 was well tolerated, with significant reductions in LFC after 12 weeks of treatment with 80 mg and 160 mg."

Clinical • Journal • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Single-cell transcriptomics reveals THR-β agonist treatment increases macrophage proportion and inhibits complement pathway in mice with metabolic dysfunction-associated steatohepatitis (EASL 2025) - "Background and Aims: Thyroid hormone receptor (THR)-β agonist resmetirom has been approved by the U.S. FDA as the first drug for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). Treatment with the THR-β agonist HSK31679 in MASH mice resulted in an increased proportion of liver macrophages and suppressed complement activation pathways in these cells. Additionally, communication between liver cell subsets, particularly between hepatocytes and macrophages, was enhanced."

Preclinical • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Haisco plans to raise no more than 1.365 billion yuan through a private placement to invest in new drug research and development projects and replenish cash flow [Google translation] (STCN) - "On the evening of February 27, Haisco (002653) announced its plan to issue A-shares to specific objects in 2025. The company plans to issue no more than 70 million shares to specific objects, and the total amount of funds raised will not exceed 1.365 billion yuan....According to the plan, the research and development of innovative drugs raised by Haisco this time include HSK31679 (non-alcoholic fatty hepatitis), HSK31858 (respiratory diseases), propofol (general anesthesia), HSK39297 (paroxysmal nocturnal hemoglobinuria, primary IgA nephropathy), HSK21542 (postoperative pain, postoperative nausea and vomiting) and HL231 (respiratory diseases) and other drugs for subsequent domestic and overseas clinical research and market registration."

Financing • Anesthesia • Metabolic Dysfunction-Associated Steatohepatitis • Paroxysmal Nocturnal Hemoglobinuria • Respiratory Diseases

To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) . (clinicaltrials.gov) - P2 | N=180 | Active, not recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

Thyroid hormone receptor-beta agonist HSK31679 alleviates MASLD by modulating gut microbial sphingolipids. (PubMed, J Hepatol) - "This study provided novel insights into the indispensable gut microbiota for HSK31679 treatment, which revealed microbial GCS may serve as its prognostic biomarker of MASH treatment, as well as the new target for further strategies of microbiota-based MASH therapeutics."

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

HSK31679-102: Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK31679 in Healthy Adult Male Volunteers. (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Xizang Haisco Pharmaceutical Co., Ltd | Trial completion date: Mar 2024 ➔ Dec 2024

Trial completion date

Efficacy and safety of HSK31679, a thyroid hormone receptor β agonist, for the treatment of asian nonalcoholic fatty liver disease: a multicenter randomized, double-blind, placebo-controlled, phase 2a trial (EASL-ILC 2024) - "Subjects were stratified according to the LFC≥ 17.5% or <17.5% and were randomized 1: 1: 1: 1: 1 to oral HSK31679 doses of 40mg QD, 80mg QD, 160mg QD, placebo, or ezetimibe 10mg QD. In Asian patients with NAFLD, 12 weeks of HSK31679 treatment was safe and well tolerated, with 80mg and 160mg treatment significantly reducing LFC."

Clinical • Late-breaking abstract • P2a data • Cardiovascular • Diabetes • Dyslipidemia • Hepatology • Hypertension • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD） (clinicaltrials.gov) - P2 | N=210 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Dyslipidemia • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Hsk31679 (A Thyroid Hormone Receptor Β Agonist) in Asian NAFLD with Hypercholesterolemia (APASL 2024) - "Subjects were randomised 1:1:1:1:1 to oral HSK31679 doses of 40mg QD, 80mg QD, 160mg QD, placebo, or Ezetimibe 10mg QD. This study will show the safety and efficacy of THR-β agonist in the Asian NAFLD population."

Dermatology • Diabetes • Dyslipidemia • Hepatology • Hypertension • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease

Pharmacokinetics, Mass Balance, and Metabolism of [14C]HSK31679 in Healthy Adult Male Volunteers. (clinicaltrials.gov) - P1 | N=6 | Active, not recruiting | Sponsor: Xizang Haisco Pharmaceutical Co., Ltd

New P1 trial

Ascending Single-Dose and Multiple-Dose Study to Evaluate HSK31679 in Healthy Subjects and Subjects With Elevated LDL-C (clinicaltrials.gov) - P1 | N=96 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

Trial completion

To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) . (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Hepatology • Non-alcoholic Steatohepatitis

Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD） (clinicaltrials.gov) - P2 | N=200 | Active, not recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dyslipidemia • Hepatology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease

Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD） (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Dyslipidemia • Hepatology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease

Study of HSK31679 in Subjects With Hypercholesterolemia With Nonalcoholic Fatty Liver Disease（NAFLD） (clinicaltrials.gov) - P2 | N=200 | Not yet recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Dyslipidemia • Hepatology • Metabolic Disorders • Non-alcoholic Fatty Liver Disease

Ascending Single-Dose and Multiple-Dose Study to Evaluate HSK31679 in Healthy Subjects and Subjects With Elevated LDL-C (clinicaltrials.gov) - P1 | N=96 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1 trial