Ascletis Pharma has posted 7.7% weight loss for the highest dose of its own entrant in the highly contested oral GLP-1 race.
The Chinese biotech evaluated three different once-daily doses of its oral GLP-1 agonist, dubbed ASC30, in a phase 2 study of 125 participants in the U.S. with obesity or overweight who have at least one weight-related comorbidity.
The 20-mg, 40-mg and 60-mg doses were tied to placebo-adjusted mean body weight reductions of 5.4%, 7% and 7.7%, respectively at 13 weeks, Ascletis explained in a Dec. 8 release. All three results were statistically significant, according to the company, which pointed out that no plateau in weight loss had been observed.
Ascletis’ results come in the upper half of the growing wave of oral obesity drug readouts over the past year. While the size of the trials and challenges of cross-trial comparisons make picking winners impossible at this stage of the oral obesity race, it looks like Ascletis will have some tough competition on its hands.
Novo Nordisk is awaiting an FDA approval decision for the oral version of its blockbuster obesity injection Wegovy, which has been tied to 15.1% weight loss after a longer period of 68 weeks at a 50-mg daily dose.
Meanwhile, Novo’s oral amylin and GLP-1 receptor co-agonist was tied to 13.1% weight loss after 12 weeks in a phase 1 study when given at a 100-mg daily dose. A 50-mg dose of Novo’s candidate was associated with 10.4% weight loss over the same period.
When Eli Lilly reported that its own oral GLP-1, called orforglipron, had demonstrated 12.4% weight loss over the far longer period of 72 weeks, an executive at the Big Pharma described the findings “as good as it gets for GLP-1 monotherapy here in the once-a-day small molecule [space].”
One issue that analysts flagged with orforglipron was that gastrointestinal adverse events (AEs) appeared to persist after the initial titration period, something that hasn’t emerged in its peptide counterparts.
In its results this morning, Ascletis said that when titrated weekly to the target dose, the vomiting rate for patients on ASC30 “was approximately half of the published vomiting rate observed with orforglipron titrated weekly.”
All gastrointestinal AEs were grade 1 or 2 and “mostly occurred during the dose titration period,” said Ascletis. No AEs of any description were graded 3 or above, and there were no drug-related serious AEs.
“We are excited about the results from our phase 2 study, which suggests a potential best-in-class profile of ASC30 for both weight loss and GI tolerability,” Ascletis CEO Jinzi Jason Wu, Ph.D., said in this morning’s release.
“Given the significant improvement in GI tolerability seen with the GLP-1 agonist class when titration is slowed from weekly to every four weeks, we expect the GI tolerability of ASC30 tablets to be further improved in phase 3 studies when titrated every four weeks,” the CEO added.
The biotech plans to submit the data to the FDA and request an end-of-phase 2 meeting in the first quarter of 2026.
Today’s readout follows Ascletis’ move in March to retreat from its antiviral, oncology and liver programs in order to go all-in on metabolic disease.
Other contenders in the oral obesity race include Viking Therapeutics, which reported phase 2 data over the summer that tied its oral obesity drug candidate to weight loss of up to 12.2% after 13 weeks. But with 38% of patients discontinuing treatment at the most effective dose, investors appeared unenthused.