16.3% weight loss in the second phase of the structure obesity pills

Structure Therapy’s oral weight-loss drug, alaniglipron, has led to strong weight loss in a Phase II obesity trial — results that analysts suggest put the drug ahead of Eli Lilly’s orforglipron as a potential market competitor.

During the mid-phase ACCESS study (NCT06693843), an oral glucagon-like peptide-1 receptor agonist (GLP-1RA) induced a statistically significant placebo-adjusted weight loss of 16.3%, which was equivalent to 39lbs, 1804 grams per week after treatment with the drug.

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This result was mirrored in the open-label extension (OLE) portion of the ACCESS study, in which patients at the 120mg dose continued to lose weight for 36 weeks, with a 40.5lbs (16.2%) reduction observed at the 52-week mark. Study operators have so far seen evidence of weight loss in the ACCESS and ACCESS OLE trials.

Despite the drug’s promising efficacy profile, aligliprone has been shown to be safe and tolerable, with its profile mirroring that of the GLP-1RA class. In the ACCESS study, the treatment-emergent adverse event (TEAE)-related discontinuation rate was 3.4% in the aligliprone arm, with a median patient follow-up time of 20 weeks.

Following the results of this study, the formulation will continue its efforts to advance aleniglipron to late-stage trials, with the biotech expecting to begin Phase III clinical development for the drug in H2 2026.

Aleniglipron shows “injectable efficacy”.

In a March 16 statement detailing the results, Formulation’s CEO, Raymond Stevens, noted that data from the Phase II program of aliglipron show a “clearly different” profile of the drug from other oral GLP-1RAs such as orforglipron.

Stevens also highlighted the drug’s potential to become “the best-in-class oral GLP-1RA with injectable efficacy.”

While William Blair’s analyst, Andy Hsieh, also took a positive stance on this reading, he noted that it is likely “premature” to say that alniglipron may be the best drug in the class that is clinically different from Eli Lilly’s oral GLP-1RA, orforglipron, which is due to the regulatory decision by the US Food and Drug Administration’s Adugminist and Adugminist26 April.

However, Hsieh noted that “the growing appetite for oral, small-molecule GLP-1RAs, particularly in the former, middle, or low-income countries of the United States,” presents a significant market opportunity for aligliprone.

Shahrouz Mahmood, senior analyst at Global Data, believes that these results are at the “upper limit” of what has been demonstrated so far in terms of the effectiveness of the oral class, although differences in study duration, titration design, baseline patient characteristics, and predictor definitions limit the validity of the trial design between indirect or indirect complexes or indirect complexes.

When talking about tolerance, Mahmoud said the results warrant very careful reading. “The December 2025 results confirmed 10.4% in all active arms in the ACCESS phase II titration phase and 27.9% in the ACCESS II titration phase, both under a starting dose of 5mg,” Mahmoud said.

Although an almost zero discontinuation rate was observed in the OLE study, Mahmoud noted that the study group consisted primarily of patients who had already undergone primary traction, making interpretation difficult in isolation. “The true tolerability profile of the 2.5mg initiation strategy will only be fully characterized in phase III,” he added.

To achieve a significant share of the oral GLP-1RA market, Mahmoud said aliglipron will need to confirm that the 15-16% weight loss signal is sustained over long-term treatment in a wider population, while also demonstrating that a starting dose of 2.5mg translates to real-world follow-up in phase III. “The latter possibility is a very important question from a commercial point of view, as oral GLP-1RA therapy is being developed as a potential maintenance therapy,” Mahmoud added. Mehmood added.

If aleniglipron receives approval, it will enter the market that the parent company of Global Data Clinical trial fieldforecast to exceed $173.5 billion by 2031.

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