Structure Therapeutics announced on Mar. 16 that its investigational GLP-1 pill, aleniglipron, achieved significant placebo-adjusted weight loss in a Phase 2 clinical trial, drawing comparisons to leading treatments from Novo Nordisk and Eli Lilly.
The findings are important as the market for oral obesity medications is rapidly expanding, with major pharmaceutical companies competing to develop effective and safe options for patients. Structure's results suggest its candidate could become a strong contender in this field.
According to BMO Capital Markets analysts, a follow-up at 44 weeks from the ACCESS II study "shows what we believe to be a competitive profile vs. orforglipron and the Wegovy Pill." The trial enrolled 85 adults who were either obese or overweight with at least one related health condition. Three doses of aleniglipron were tested: 120 mg, 180 mg, and 240 mg. At the 44-week mark, patients taking the 180-mg dose saw an average placebo-adjusted weight reduction of 16.3%, which was described as highly statistically significant by Structure Therapeutics. The higher dose of 240 mg resulted in a slightly lower reduction of 16%.
Additional data from a separate open-label extension study showed up to a 16.2% reduction in weight at week 56 with the lowest dose tested (120 mg). Both studies have not yet shown signs that the effect is plateauing, according to Structure.
BMO analysts said, "Even at the 180mg dose, efficacy looks to be highly competitive and better than orforglipron and the Wegovy pill." Regarding safety, there was one discontinuation due to an adverse event in ACCESS II and two percent of participants stopped treatment because of side effects in the open-label extension. BMO noted potential investor concerns about these safety signals but added that such cases remain infrequent: they "are something we’re watching." The analysts also said Structure "is working to further optimize dose titrations, using a low and slow method."
With these results, Structure plans to advance aleniglipron into late-stage development later this year. The company enters an increasingly competitive landscape as regulatory decisions approach for other oral GLP-1 drugs; Eli Lilly’s orforglipron is expected to receive Food and Drug Administration approval by April 10.
Currently, Novo Nordisk holds exclusive approval for an oral weight loss medication with its Wegovy pill.
