Ascletis has begun global Phase III trials of ASC30, a once‑daily oral GLP‑1 candidate for chronic weight management, after FDA clearance. Two randomised, placebo‑controlled studies—AURORA‑1 (non‑diabetic) and AURORA‑2 (with T2D)—will enrol about 4,600 participants across the US, Canada and Europe and test 20 mg, 40 mg and 60 mg daily doses. Each trial runs 72 weeks with staggered titration periods; topline results are expected in Q3 2028, with US and EU regulatory filings planned for late 2028 and early 2029. Ascletis reports cash runway into 2029 and continues to advance related oral obesity candidates, including recent IND clearance for ASC35.
Ascletis Launches Global Phase III Program for Oral GLP‑1 Candidate ASC30 After FDA Clearance
AURORA-1 will study individuals with obesity without type 2 diabetes. Credit: New Africa / Shutterstock.com.
Ascletis Pharma has initiated a global Phase III clinical programme for ASC30, its once‑daily oral small‑molecule glucagon‑like peptide‑1 (GLP‑1) receptor agonist for chronic weight management, following clearance from the US Food and Drug Administration (FDA).
Study Design and Scope
The Phase III effort comprises two multicentre, randomised, double‑blind, placebo‑controlled trials—AURORA‑1 and AURORA‑2—that together will enrol approximately 4,600 participants with obesity or overweight across the United States, Canada and Europe. AURORA‑1 will evaluate participants without type 2 diabetes (T2D), while AURORA‑2 will enrol participants with T2D.
Doses, Duration and Titration
Both trials will assess long‑term efficacy, safety and tolerability of three once‑daily maintenance doses of ASC30: 20 mg, 40 mg and 60 mg. Each study has a total duration of 72 weeks. Dose titration periods differ by cohort and are planned at 12 weeks for the 20 mg group, 16 weeks for the 40 mg group and 20 weeks for the 60 mg group.
Timelines and Regulatory Plans
Ascletis expects topline Phase III results in the third quarter of 2028. The company plans a US new drug application (NDA) submission by the end of 2028 and an application to the European Medicines Agency (EMA) in early 2029.
Financial Position and Pipeline
Ascletis reports it has sufficient cash resources to fund operations into 2029, covering the period beyond the planned regulatory submissions. The company is advancing a broader oral obesity portfolio: ASC30 (GLP‑1), ASC48 (GIP) and ASC39 (amylin SARA). Ascletis says it has addressed formulation and fixed‑dose combination challenges and highlighted new data on a first‑in‑class oral triple‑agonist fixed‑dose combination (GLP‑1/GIP/amylin).
Dr Jinzi Jason Wu, founder, chairman and CEO of Ascletis, said: "Following positive end‑of‑Phase II interactions with the FDA, we are pleased to have initiated the global Phase III programme of ASC30, the primary pillar of our one‑pill once‑daily oral small‑molecule obesity portfolio. The new data for our first‑in‑class oral triple‑agonist fixed‑dose combination reinforce our industry‑leading, differentiated portfolio for treating obesity and other metabolic diseases."
Separately, in June 2026 Ascletis received investigational new drug (IND) clearance from the FDA to initiate a Phase I study of ASC35 for obesity.
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