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Ascletis Completes Enrollment in U.S. Phase IIa Study for Its Small Molecule Oral GLP-1R Agonist, ASC30, in Participants with Obesity or Overweight
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today completion of enrollment in its U.S. 13-week Phase IIa study evaluating ASC30, a small molecule oral GLP-1 receptor (GLP-1R) agonist for the treatment of obesity (NCT07002905). All 125 participants are obese or overweight with at least one weight-related comorbidity.
About this update from Ascletis Pharma, Inc.
[{"type":"text","content":"- 13-week U.S. Phase IIa study is evaluating the efficacy, safety and tolerability of two oral formulations of ASC30, a once-daily tablet, in 125 participants with obesity or overweight.","length":240,"tagName":"p"},{"type":"text","content":"- All 125 participants enrolled in just over one month; topline data expected in the fourth quarter of 2025.","length":161,"tagName":"p"},{"type":"text","content":"HONG KONG, Aug. 5, 2025 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today completion of enrollment in its U.S. 13-week Phase IIa study evaluating ASC30, a small molecule oral GLP-1 receptor (GLP-1R) agonist for the treatment of obesity (NCT07002905). All 125 participants are obese or overweight with at least one weight-related comorbidity.","length":394,"tagName":"p"},{"type":"text","content":""We are excited to announce this important milestone, which brings us another step closer to delivering ASC30 as a potential unique and differentiated treatment for obesity," said Jinzi Jason Wu, Ph.D., Founder, Chairman and CEO of Ascletis, "The rapid pace of enrollment of 125 participants in just over one month underscores the unmet medical need for additional treatment options for obesity. We are looking forward to topline data from this Phase IIa study in the fourth quarter 2025. As a small molecule, ASC30 has the potential to offer both once-daily oral and once-monthly subcutaneous injection dosing options for obesity treatment, if approved."","length":680,"tagName":"p"},{"type":"text","content":"The Phase IIa study is a 13-week, randomized, double-blind, placebo-controlled and multi-center study to evaluate the efficacy, safety, and tolerability in participants with obesity (body mass index (BMI) ≥ 30 kg/m2) or overweight (BMI ≥ 27 kg/m2 but < 30 kg/m2) with at least one weight-related comorbidity. Two oral formulations of one-daily ASC30 are being evaluated: formulation 1 (ASC30 tablets) and formulation 2 (ASC30 tablets A1). The primary endpoint of the study is the mean percentage body weight change from baseline at Week 13. The 13-week study protocol has a low starting dose of 1 mg of both formulation 1 and formulation 2, with we...