Catalyst overview
Research summary
This catalyst tracks a Phase 2 data readout for Aleniglipron (GSBR-1290) in Obesity, Type 2 diabetes. The expected timing is based on the latest available company guidance and may change.
ACCESS & ACCESS II trials. 6/3/24- Positive Full 12-wk obesity data. 11/13/24- Dosed first patient in ACCESS trial. To dose first patient in ACCESS II trial by YE 2024. 8/6/25- Topline data for both trials by YE 2025. 11/06/25:- ACCESS and ACCESS II Ph2b studies remain on track for topline 36-week data by YE 2025, and multiple supplementary Ph2 studies (maintenance switch, body composition, and T2DM with obesity/overweight) are ongoing or fully enrolled with no additional timing disclosed. 12/08/25:- Reported positive 36-week topline ACCESS and ACCESS II data; plan Ph3 start by Mid-2026. 02/26/26:- ACCESS II 44-week topline data expected Q1 2026. Phase 3 program initiation now anticipated in H2 2026. 03/16/26:- Reported positive ACCESS II 44-week topline and OLE interim data. End-of-Phase 2 FDA meeting Q2 2026; Phase 3 2H 2026. 04/27/26:- ADA 2026: ACCESS oral Jun 5; ACCESS II poster Jun 8; lower-dose poster Jun 7. 05/07/26:- ACCESS OLE topline Q3 2026; Body Composition, T2DM, SWITCH data and Phase 3 start all Q3–Q4 2026 after FDA feedback. 08/06/26:- Phase 3 ACCOMPLISH dosing began. OLE data Q3 2026. Body, T2DM and SWITCH data Q4 2026.
Verification
Confirm timing and program details against the company announcement or filing.