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8-KAccepted Sep 8, 8:09 AM ET

Structure Therapeutics Announces Positive Clinical Results for Oral Amylin & GLP-1 Programs

GPCRStructure Therapeutics Inc.

Accepted (ET)

8:09 AM

Sep 8, 2026

Filed

Sep 8, 2026

Documents

50

Size

8.0 MB

Summary

Structure Therapeutics Announces Positive Clinical Results for Oral Amylin & GLP-1 Programs

Updated

What Happened

  • On September 8, 2026 Structure Therapeutics (GPCR) announced positive topline clinical data for two oral weight‑management programs. The Phase 1 single ascending dose (SAD) portion for ACCG‑2671 (oral small‑molecule DACRA) in 31 healthy adults showed favorable PK (Tmax 1–1.5 hrs, terminal half‑life ~6 days), early pharmacodynamic signals (single 10 mg dose → mean −3.3% body weight at Day 24; ~60% reduction in CTX‑1 at Day 2), and an acceptable tolerability profile with dose‑related GI events at ≥5 mg. The company also reported 72‑week results from the ACCESS open‑label extension (OLE) of aleniglipron (oral GLP‑1 agonist) showing sustained weight loss and consistent safety through 72 weeks.

Key Details

  • ACCG‑2671 SAD: 31 healthy adults; single doses 1, 2, 5, 10 mg; no serious AEs or drug‑induced liver injury; nausea/vomiting rose at 5 mg (nausea 4/5, vomiting 3/5) and 10 mg (6/6). MAD portion in people with obesity is ongoing; MAD topline data expected H1 2027.
  • ACCG‑2671 PK/PD: rapid absorption (Tmax 1–1.5 hr), terminal half‑life ≈6 days (supports daily or weekly dosing), single 10 mg → mean −3.3% weight by Day 24; CTX‑1 ↓ ~60% Day 2 (bone resorption biomarker).
  • Aleniglipron ACCESS OLE (72 weeks): participants continuing from 45/90/120 mg arms who titrated up to 180 mg achieved mean weight loss of 11.6%, 14.4%, and 16.2%, respectively; >1/3 in the top dose cohorts achieved >20% weight loss; mean absolute loss up to ~40.5 lbs in the 120 mg cohort. Placebo crossovers starting at 2.5 mg lost 9.0% (22.7 lbs) after 36 weeks. TEAE discontinuations <5%; no drug‑induced liver injury observed.
  • Ongoing Phase 3 ACCOMPLISH program: ACCOMPLISH‑1 (up to 3,600 participants) and ACCOMPLISH‑2 (up to 1,100 with T2DM) evaluate maintenance doses 45/90/180 mg after 2.5 mg start; topline Phase 3 data expected H2 2028.

Why It Matters

  • These topline results provide early clinical proof‑of‑concept for two oral obesity therapies: ACCG‑2671 (amylin/CALCR agonist) and aleniglipron (GLP‑1 agonist). ACCG‑2671’s PK/PD and tolerability support continuing into MAD testing (including combination with injectable GLP‑1), while aleniglipron’s durable 72‑week weight loss supports advancing and enrolling large Phase 3 trials. Investors should note upcoming catalysts: ACCG‑2671 MAD topline data in H1 2027 and aleniglipron Phase 3 topline data in H2 2028. The company also cautioned these are preliminary/topline results and subject to change after full review.

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