Hong Kong – August 3, 2026
Ascletis Pharma Inc. has initiated a global Phase III clinical development program for ASC30, its once-daily oral small molecule GLP-1 receptor agonist, following Phase III clearance from the U.S. Food and Drug Administration (FDA). The program represents a major advancement for Ascletis’ obesity and metabolic disease pipeline and will evaluate ASC30 for chronic weight management in approximately 4,600 participants with obesity or overweight across the United States, Europe and Canada. ASC30 is positioned as the primary pillar of the company’s expanding portfolio of oral small molecule therapies targeting GLP-1, GIP and amylin pathways.
Two Pivotal Phase III Trials Target Obesity and Overweight
The global Phase III program consists of two pivotal, multicenter, randomized, double-blind, placebo-controlled studies, AURORA-1 and AURORA-2. AURORA-1 will evaluate ASC30 in participants with obesity or overweight who do not have type 2 diabetes, while AURORA-2 will study patients with obesity or overweight and type 2 diabetes. Both trials will assess the long-term efficacy, safety and tolerability of three maintenance doses of once-daily oral ASC30 — 20 mg, 40 mg and 60 mg — compared with placebo. Treatment will continue for 72 weeks, with different dose-titration periods for each maintenance-dose cohort. Ascletis expects to announce topline Phase III results in the third quarter of 2028. The company is targeting a U.S. New Drug Application filing by the end of 2028, followed by a European Marketing Authorisation Application in early 2029. If ultimately approved by regulators, Ascletis believes ASC30 could potentially become the second oral small molecule GLP-1 therapy approved in the United States and Europe after orforglipron.
Triple Agonist Expands Oral Metabolic Disease Pipeline
Alongside the Phase III milestone, Ascletis reported positive preclinical data for ASC30_48_39FDC, its once-daily oral small molecule fixed-dose combination targeting GLP-1, GIP and amylin. In non-human primates, the triple agonist combination demonstrated a dose-dependent body weight reduction of up to 15.2% after seven days of treatment. According to Ascletis, this represented up to a 120% greater relative body weight reduction compared with its oral GLP-1/amylin dual agonist combination in the reported preclinical experiment. The company said the results indicate that the GIP component, ASC48, plays an important role in the triple agonist combination. These findings remain preclinical and will require clinical evaluation to determine whether comparable efficacy and safety can be achieved in humans. Ascletis is developing a broader oral metabolic portfolio that includes GLP-1, GIP and selective amylin receptor agonist programs, both individually and as fixed-dose combinations.
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Ascletis Builds One-Pill Obesity Treatment Strategy
Ascletis is also advancing ASC39, a once-daily oral selective amylin receptor agonist, and multiple dual and triple fixed-dose combinations. Its ASC30_48FDC GLP-1/GIP dual agonist previously demonstrated a 10.5% body weight reduction in non-human primates after eight days of treatment, while the ASC30_39FDC GLP-1/amylin combination is expected to enter clinical development in the fourth quarter of 2026. The company says its strategy is designed to create a comprehensive one-pill, once-daily oral treatment portfolio for obesity and other metabolic diseases, potentially providing alternatives to injectable incretin-based medicines. Ascletis reported that it has sufficient cash to support operations into 2029, extending beyond its anticipated ASC30 regulatory submissions. The initiation of the ASC30 global Phase III program, combined with continued development of novel oral dual and triple agonist combinations, strengthens Ascletis’ position in the rapidly evolving field of next-generation obesity therapeutics and metabolic medicine.
Source: Ascletis Pharma press release
