Structure Therapeutics reported that its investigational oral GLP-1 candidate, aleniglipron, achieved over 11% weight loss in a Phase IIb clinical trial. According to BMO Capital Markets, this level of efficacy is “highly competitive” compared to other leading oral obesity treatments currently in development.
BMO analysts highlighted the potential for aleniglipron to become a significant player in the obesity treatment market alongside Eli Lilly’s orforglipron. They stated, “Strong weight loss, coupled with a tolerability profile comparable to Lilly’s Ph2 Orforglipron data, paint a clear path to Ph 3 and meaningfully de-risk the program in our view.”
Following the announcement, Structure Therapeutics’ stock price closed at $69.98 on Monday, nearly doubling from its previous close of $34.57 on Friday.
In the ACCESS II study, patients who received 120 mg of aleniglipron experienced an 11.3% placebo-adjusted reduction in body weight after 36 weeks. Lower doses of 45 mg and 90 mg resulted in weight losses of 9.8% and 8.2%, respectively, over the same period. All results were statistically significant when compared with placebo.
An exploratory analysis using a higher dose of 240 mg showed a placebo-adjusted weight reduction of 15.3% at week 36.
Regarding safety, side effects associated with aleniglipron were similar to those observed across the GLP-1 drug class and did not include drug-induced liver injuries or persistent elevations in liver enzymes at any dose tested. Gastrointestinal issues were the most common adverse events reported among participants.
William Blair analysts also expressed optimism about Structure’s data: they wrote that results are “sufficient for aleniglipron to compete in the large and growing small-molecule GLP-1 receptor agonist class.” The firm noted similarities between ACCESS II outcomes and those seen with Lilly’s orforglipron in Phase III studies.
They further commented on recent market dynamics: “The stock is currently trading up about 100% likely driven by the M&A prospect,” referencing recent acquisition interest involving major pharmaceutical companies Pfizer and Novo Nordisk.
However, William Blair cautioned that it is “premature to declare aleniglipron as best-in-class,” citing unresolved questions about whether its weight-loss effect will plateau beyond 36 weeks and what benefits might be realized from higher doses.
Structure Therapeutics plans to meet with the FDA at the end of Phase II early next year and may begin late-stage trials for aleniglipron by mid-2026.
