Recently, the phase II clinical trial of Hisikao's innovative drug HSK31679 tablets has received ethical approval from the medical ethics committees of Peking University First Hospital and Beijing Tsinghua Changgeng Hospital, the two leading institutions involved. The main purpose of this phase II clinical trial is to evaluate the efficacy and safety of HSK31679 tablets at various dosing levels compared to placebo in patients with hypercholesterolemia and non-alcoholic fatty liver disease (NAFLD), in reducing low-density lipoprotein cholesterol (LDL-C) and liver fat content. The trial will be conducted at 25 research centers across the country, with approximately 200 participants expected.

HSK31679 is a highly selective thyroid hormone β-receptor (THR-β) agonist developed by Haisco. The drug has completed Phase I clinical trials, and Phase II clinical trials are now officially started at Peking University First Hospital and Beijing Tsinghua Changgeng Hospital. The project is progressing smoothly.

Mechanism diagram

Non-alcoholic fatty liver disease (NAFLD) is a severe late-stage form of non-alcoholic fatty liver disease that can progress to cirrhosis, liver failure, and hepatocellular carcinoma, and it rarely resolves on its own. It is estimated that approximately 4% of adults worldwide may suffer from NASH, with over 50 million patients in China. The number is expected to grow rapidly in the future, resulting in a large market size. However, drug research in the NASH field has encountered setbacks, and currently, no medication therapy has been approved for treating NASH globally.

The Resmetirom drug developed by Madrigal, which targets the same as HSK31679, achieved dual major clinical endpoints in phase III clinical trial MAESTRO-NASH and yielded positive results. It is expected to become the first approved drug for treating NASH.

HSK31679 has good development prospects and is expected to provide many NASH patients with a new and better treatment option.