Structure Therapeutics Inc. filed a Form 8-K with the SEC on September 8, 2026, disclosing positive topline clinical trial results for two oral small molecule programs targeting chronic weight management: ACCG-2671 and aleniglipron.

Key Highlights

  • ACCG-2671 SAD trial: 31 healthy adult participants without obesity were evaluated; no serious adverse events, no drug-related TEAEs leading to discontinuation, and no drug-induced liver injury were reported.
  • Single-dose weight effect: A single 10 mg dose of ACCG-2671 (n=6) was associated with mean body weight reductions of 3.3% at Day 24, according to the filing.
  • Bone biomarker signal: CTX-1, described as a biomarker of bone resorption, decreased by approximately 60% on Day 2 across active dose cohorts of ACCG-2671.
  • Aleniglipron 72-week weight loss: Participants originally in the 120 mg arm who continued into the ACCESS OLE achieved weight loss of 16.2%, with mean absolute body weight loss of 40.5 pounds.
  • Crossover participants: Placebo participants who crossed over to aleniglipron at Week 36 starting with a 2.5 mg dose achieved weight loss of 9.0%, or 22.7 pounds, after 36 weeks of treatment.
  • Phase 3 program: Aleniglipron is being evaluated in ACCOMPLISH-1, enrolling up to 3,600 adults, and ACCOMPLISH-2, enrolling up to 1,100 adults with obesity or overweight and type 2 diabetes mellitus.
  • MAD topline data timing: Topline data for the MAD portion of the Phase 1/2a ACCG-2671 trial are expected in the first half of 2027.

ACCG-2671 SAD Findings and Aleniglipron ACCESS OLE Results

According to the filing, the SAD portion of the Phase 1/2a trial for ACCG-2671 evaluated single doses of 1, 2, 5, or 10 mg versus placebo in 31 healthy adults without obesity. The company reported that ACCG-2671 showed rapid absorption with Tmax at 1 to 1.5 hours and a terminal half-life of approximately 6 days, which the filing states supports evaluation of both daily and weekly dosing. Exposure was described as consistent with dose proportionality. Dose-related gastrointestinal events emerged at 5 mg, with nausea in 4 of 5 participants and vomiting in 3 of 5 participants, and at 10 mg in 6 of 6 participants. The company disclosed that the MAD portion, evaluating 84 days of dosing across five cohorts of participants living with obesity, is now underway and includes a cohort receiving a stable dose of an injectable GLP-1 receptor agonist.

For aleniglipron, the filing reported 72-week results from the ACCESS OLE, a prespecified 36-week extension of the Phase 2b ACCESS clinical trial (NCT06693843). Approximately 87% of eligible completers from the 36-week double-blind period entered the OLE. Participants originally randomized to the 45 mg, 90 mg, and 120 mg arms achieved weight loss of 11.6%, 14.4%, and 16.2%, respectively, with the filing noting no evidence of a weight loss plateau in the two top doses. More than one-third of participants in the 90 mg and 120 mg cohorts achieved more than 20% body weight reduction. Treatment discontinuations due to TEAEs occurred in fewer than 5% of OLE participants, and no cases of drug-induced liver injury were reported.

The filing also disclosed that participants who crossed over from placebo to aleniglipron using a 2.5 mg starting dose and gradual up-titration showed improved gastrointestinal tolerability compared with the 5 mg starting dose used in the double-blind portion of ACCESS. All observed liver-enzyme elevations resolved without treatment discontinuation, consistent, the company stated, with prior aleniglipron clinical trials. The disclosure was furnished under Item 7.01 and Item 8.01 of the Form 8-K and is listed as trading on NASDAQ:GPCR.

What Was Disclosed

Structure Therapeutics disclosed Phase 1 SAD topline results for ACCG-2671 and 72-week ACCESS OLE results for aleniglipron via a Form 8-K filed September 8, 2026, alongside a press release and investor presentation furnished as exhibits.