Oral GLP‑1 hits 16%
Structure Therapeutics’ once‑daily oral GLP‑1 aleniglipron produced a placebo‑adjusted 16.3% mean weight loss at 44 weeks—about 39 lbs for the 180 mg arm and 16.0% (~37 lbs) for the 240 mg arm—with no evidence of a weight‑loss plateau at study end GlobeNewswire CTV News. The company reported tolerability suitable for chronic use and plans a pivotal Phase 3 in H2 2026—news that lifted Structure’s stock about 10% in early trading MedCity News StockTitan.
ACCESS II was run as a randomized, double‑blind, placebo‑controlled Phase 2 study that enrolled an estimated 82 participants across 10 U.S. sites ([clinicaltrials.gov)]. Participants in the study began dosing at 5 mg and were escalated on a four‑week titration schedule to prespecified target doses (including 120 mg, 180 mg and 240 mg) ([ir.structuretx.com)]. Across active arms, the company reported an adverse‑event‑related treatment discontinuation rate of 3.7% among participants who reached ≥120 mg in ACCESS II, with lower discontinuation rates (reported between 2.0% and 3.4%) observed in the ACCESS open‑label extension and body composition substudies when a 2.5 mg starting dose was used ([ir.structuretx.com)]. Structure says there have been no reported cases of drug‑induced liver injury, no persistent liver‑enzyme elevations, and no QTc prolongation across its aleniglipron clinical program to date ([ir.structuretx.com)]. The interim tolerability analyses cited a median follow‑up of roughly 20 weeks for the OLE/body‑composition cutoffs, with the company attributing improved titration tolerability to the lower starting dose as of the February 20, 2026 data cutoff ([ir.structuretx.com)]. Structure filed the ACCESS records under sponsor Gasherbrum Bio, a wholly owned subsidiary of Structure Therapeutics, and has scheduled an End‑of‑Phase‑2 meeting with the FDA in Q2 2026 as it prepares a pivotal program design ([clinicaltrials.gov)].
