Structure's two Phase 3 aleniglipron trials show as recruiting on the registry
Structure Therapeutics' oral GLP-1 pill aleniglipron has entered two Phase 3 trials meant to prove it can compete with injectable weight-loss drugs, with results not expected until late 2028.
Registry records show that Structure Therapeutics' two Phase 3 trials for its oral GLP-1 drug aleniglipron are now recruiting participants [1]. ACCOMPLISH-1 plans to enroll up to 3,600 adults with obesity or overweight who also have a weight-related health condition, while ACCOMPLISH-2 plans to enroll up to 1,100 adults with obesity or overweight and type 2 diabetes [1]. Structure says the ACCOMPLISH program began in August 2026, with topline results expected in the second half of 2028 [2].
Aleniglipron is a small-molecule pill, not an injection, and the company is positioning it as a rival to approved GLP-1 shots like Wegovy (semaglutide) and Zepbound (tirzepatide), as well as to Eli Lilly's oral candidate orforglipron. The push into Phase 3 follows 72-week data from an earlier trial extension, called ACCESS OLE, which Structure reported on September 8, 2026 [2]. In that open-label extension, participants taking the 180 mg dose lost up to 16.2% of their body weight by week 72, with no sign that weight loss had leveled off [2].
The company also reported a tolerability change it says matters for how the drug moves forward. Participants who had been on placebo and then crossed into open-label aleniglipron started at a lower 2.5 mg dose, instead of the original 5 mg starting dose used earlier in the study, and these participants showed improved tolerability [2]. Across all dose groups in the extension, fewer than 5% of participants stopped treatment because of side effects, and the company reported no new safety signals outside the drug's known effects [2]. Structure's chief medical officer, Blai Coll, said the results "reinforce aleniglipron's consistent and potentially class-leading weight loss profile" [2]. Chief executive Raymond Stevens said the Phase 3 launch puts the company "in a very strong position to be highly competitive" [2].
Why it matters for patients
For people currently using injectable GLP-1 drugs, or considering them, aleniglipron is not yet an option and will not be for years. Phase 3 trials are the last stage before a drug can be submitted to the Food and Drug Administration, and Structure's own timeline puts topline data no earlier than the second half of 2028 [2]. That means any possible approval, and any effect on pharmacy shelves or drug prices, is still further out.
The 16.2% weight loss figure comes from an open-label extension, not the two new Phase 3 trials themselves, so it describes results in a smaller, earlier study population rather than the larger group now being enrolled [2]. The lower 2.5 mg starting dose used in the extension has not yet been tested in the ACCOMPLISH trials, so whether it holds up in a larger, more diverse group of patients is not yet known. As with any drug still in testing, the discontinuation rate, side effect pattern, and weight-loss numbers could change once more people are studied for longer periods.
What happens next
Both ACCOMPLISH-1 and ACCOMPLISH-2 are actively recruiting as of the most recent registry snapshot [1]. Structure has said it expects topline data from the ACCOMPLISH Phase 3 program in the second half of 2028 [2]. Separately, the company is also running an early-stage trial of a different drug, ACCG-2671, an oral amylin-targeting compound, with topline data from that program's next phase expected in the first half of 2027 [2]. Neither program has a stated submission date to the FDA in the material reviewed here, so any regulatory timeline beyond the 2028 trial readout is not yet known.
Sources
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