Ascletis Pharma has initiated a global Phase III clinical programme for its once-daily oral small molecule glucagon-like peptide-1 (GLP-1) receptor agonist, ASC30, for chronic weight management, following clearance from the US Food and Drug Administration (FDA).
The Phase III programme consists of two multi-centre, randomised, double-blind, placebo-controlled trials, AURORA-1 and AURORA-2, enrolling 4,600 participants with obesity or overweight in the US, Canada, and Europe.
These studies are set to assess the long-term efficacy, safety, and tolerability of three daily maintenance doses of ASC30, 20mg, 40mg, and 60mg.
AURORA-1 will focus on individuals with obesity or overweight without type 2 diabetes (T2D) while AURORA-2 will evaluate those with T2D.
Each trial has a total duration of 72 weeks; titration periods are 12, 16, and 20 weeks for the 20mg, 40mg, and 60mg dose cohorts, respectively.
Ascletis projects top line results for ASC30’s Phase III programme in the third quarter of 2028.
A US new drug application submission is planned by the end of 2028, followed by a European Medicines Agency application in early 2029.
Ascletis reports sufficient cash reserves to support its operations into 2029, beyond these submission dates.
Ascletis founder, chairman and CEO Dr Jinzi Jason Wu said: “Following recent positive end-of-Phase II feedback received from the FDA for ASC30, we are excited to have initiated the global Phase III programme of ASC30, the primary pillar of our one-pill once-daily oral small molecule obesity portfolio.
“ASC30 (GLP-1), ASC48 (GIP) and ASC39 (amylin SARA) are small molecules with different physical-chemical properties. We have overcome multiple challenges during the development of fixed-dose combinations of these molecules.
“The new data for our first-in-class oral small molecule triple agonist fixed-dose combination (GLP-1/GIP/amylin) reinforces our industry-leading, comprehensive and differentiated portfolio of one-pill once-daily oral small molecules for the treatment of obesity and other metabolic diseases.”
In June 2026, Ascletis Pharma received investigational new drug clearance from the FDA to initiate a Phase I study of ASC35 for obesity.
