Structure's oral GLP-1 aleniglipron trials show as recruiting, with topline data due in 2028

Structure Therapeutics said its two Phase 3 trials of aleniglipron, an experimental oral GLP-1 pill, are enrolling, with topline results expected in the second half of 2028 ^[2]. Registry records list ACCOMPLISH-1, which plans to enroll up to 3,600 adults with obesity or overweight and a weight-related health condition, and ACCOMPLISH-2, which plans to enroll up to 1,100 adults with obesity or overweight who also have type 2 diabetes. Both are listed as recruiting ^[1].

Aleniglipron is an oral, non-peptide small molecule that targets the GLP-1 receptor, the company says ^[2]. Small-molecule pills are one way companies are trying to deliver GLP-1 activity without an injection, and other oral candidates are in late-stage testing as well: the same registry tracking shows a Phase 3 master protocol for Eli Lilly's orforglipron in people with obstructive sleep apnea and obesity or overweight ^[1]. Structure said the aleniglipron Phase 3 program began in August 2026 ^[2]. The company has not disclosed how many sites are taking part or when enrollment is expected to close ^[2].

The Phase 3 start follows 72-week results from the ACCESS open-label extension. Participants on the 180 mg dose lost up to 16.2% of body weight on average at 72 weeks, with no sign that weight loss had plateaued ^[2]. Participants who had received placebo and then crossed over to aleniglipron in the extension began at a lower 2.5 mg starting dose and tolerated treatment better than those who started at 5 mg in the earlier ACCESS trial ^[2]. Fewer than 5% of participants in any dose group stopped treatment because of side effects, and the company reported no off-target safety signals ^[2]. ACCESS is a Phase 2b trial, and the extension is a prespecified 36-week follow-on to it ^[2].

Those weight-loss figures come from an open-label extension rather than a blinded, placebo-controlled study, so they may not predict what the much larger ACCOMPLISH trials show. Whether the 16.2% average holds up in a randomized Phase 3 population has not been reported. Structure also has not disclosed pricing plans, a proposed FDA submission date, or details about manufacturing capacity for a commercial pill ^[2].

Why it matters for patients

An oral GLP-1 would offer a pill instead of an injection, which the company argues could improve convenience and expand access. "There remains a clear need for oral therapies that have the potential to combine greater convenience with scalable and cost-effective manufacturing, broaden access and choices for the large and diverse worldwide population living with obesity," chief executive Raymond Stevens said in the release ^[2].

The timing is the practical catch. Topline Phase 3 data are not expected until the second half of 2028 ^[2], and no regulatory decision can happen before then, so a pill from this program is years away at the earliest. The two trials are also testing different groups — adults with obesity or overweight plus a related condition in ACCOMPLISH-1, and adults who also have type 2 diabetes in ACCOMPLISH-2 ^[1] — so results will speak to those populations first. How aleniglipron would compare with approved GLP-1 medicines, or how it would be priced, has not been reported.

What happens next

Both ACCOMPLISH trials are recruiting, with topline data expected in the second half of 2028 ^[2]. Structure said the multiple-ascending-dose portion of a separate Phase 1/2a trial of its oral amylin candidate, ACCG-2671, has begun dosing, with topline data expected in the first half of 2027 ^[2]. In that earlier single-dose study, a 10 mg dose produced a mean 3.3% body weight reduction at day 24 in six healthy participants, and the compound showed a half-life of about six days ^[2].