Hinova Pharmaceuticals (SH:688302) Zheng Quan Ri Bao·2025-11-04 12:41Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has announced the completion of the first participant enrollment in the Phase II clinical trial of HP515, a drug developed for the treatment of Metabolic Associated Steatotic Liver Disease (MASH) [2][3] Group 1: Clinical Trial Progress - The Phase II clinical trial of HP515 has recently completed the enrollment of its first participants [2] - HP515 is an orally administered, highly selective THR-β agonist that enhances lipid metabolism in liver cells, aiming to improve conditions related to MASH [2] - The drug received approval for clinical trials in China in August 2024 and in the United States in September 2024 [2] Group 2: Phase I Clinical Trial Results - Haichuang Pharmaceutical has completed the Phase I clinical trial of HP515, showing expected results in safety, tolerability, pharmacokinetics, and pharmacodynamics [3] - In the trial, SHBG levels increased significantly in a dose-dependent manner, with an increase of 176% at the 80mg dose after 14 days [3] - Key lipid indicators showed significant improvement, with LDL-C decreasing by 39%, TC by 28%, and ApoB by 41% at the 80mg dose [3] Group 3: Future Research Directions - The company is also conducting research on HP515 in combination with GLP-1R agonists for obesity treatment [4] - Preclinical studies indicate that HP515 may enhance weight loss effects while preserving muscle mass, potentially improving the efficacy of GLP-1R agonists [4] - Data from the combination study is set to be presented at the 32nd European Congress on Obesity in May 2025 and will be featured at the 3rd Obesity & Weight Loss Drug Development Summit in June 2025 [4]