Ascletis Initiates U.S. Clinical Study for New Obesity Treatment with ASC47 and Semaglutide

Ascletis Unveils Groundbreaking Obesity Treatment Study

Ascletis Pharma Inc. has recently announced the commencement of its pivotal clinical study aimed at tackling obesity, a growing epidemic worldwide. This innovative study, based in the United States, will assess the safety and preliminary effectiveness of ASC47, an adipose-targeted, once-monthly injectable small molecule THRβ agonist, in conjunction with Semaglutide, a well-known pharmaceutical treatment for obesity. The ASC47-103 study is pivotal in addressing obesity within participants who do not have Type 2 diabetes.

Study Design and Implementation

The ASC47-103 study has been designed as a randomized, double-blind, placebo-controlled trial. Participants will be categorized into three cohorts, each receiving a single injection of either ASC47 in varying dosages (10 mg, 30 mg, and 60 mg) or a volume-matched placebo. Alongside ASC47, all participants will also receive Semaglutide, administered at a dosage of 0.5mg each week for four weeks. This revolutionary combination is anticipated to yield insights into how ASC47 can aid in achieving significant weight loss while preserving muscle mass, setting it apart from traditional obesity treatments.

The rationale behind combining ASC47 with Semaglutide lies in their complementary mechanisms. ASC47 exhibits a remarkable half-life of up to 40 days, which was evidenced in previous Phase Ib studies. Notably, preclinical studies showed that the low dose of ASC47, when combined with Semaglutide in diet-induced obese (DIO) mice, resulted in a substantial 56.7% enhancement in weight reduction as compared to Semaglutide alone, all while preserving muscle mass. This muscle-preserving capability is crucial for preventing the adverse effects often associated with weight loss therapies.

The Importance of the ASC47-103 Study

Dr. Jinzi Jason Wu, Founder, Chairman, and CEO of Ascletis, highlighted the uniqueness of this clinical study, stating, "To our knowledge, this is the first clinical study combining the THRβ targeting mechanism and an incretin drug for obesity." The insights drawn from this study are expected to guide future trials, including a combination study of ASC47 and another compound, ASC30 (GLP-1R agonist), both of which have showcased long half-lives in earlier studies.

The ASC47-103 study not only aims to offer a fresh perspective on treating obesity but also emphasizes the necessity of addressing the medical needs of individuals facing this challenge. Obesity is linked to numerous health issues, including cardiovascular diseases, diabetes, and certain types of cancer. Thus, an efficacious treatment that can help patients lose weight without the risks of muscle loss presents a significant milestone in therapeutic strategies for obesity.

Expectations from the Study

With the first round of participants already dosed in this clinical trial, the scientific community and potential patients await the topline findings, anticipated in the fourth quarter of 2025. Ascletis is committed to sharing discoveries that emerge from this study, which may pave the way for novel, effective interventions in obesity management.

Conclusion

The initiation of this clinical study marks a promising step forward in the landscape of obesity treatment. With obesity rates at an all-time high, the research conducted by Ascletis Pharma could be foundational in developing future therapies that not only promote weight loss but also consider patient safety and overall well-being. As we look towards the results from the ASC47-103 study, there’s hope that innovative combinations like ASC47 and Semaglutide will redefine how we approach obesity and enhance quality of life for many individuals.

For more information on this exciting study and future updates, please visit Ascletis' official website.