Orforglipron
Oral SMD GLP-1 RA · GLP-1 class · oral smd · Eli Lilly
Top dose
36 mg
HbA1c reduction
-1.50%
at week 40 · treatment regimen
AE discontinuation
8.0%
Status
phase 3
Pivotal trial
- Trial
- ACHIEVE-1
- Indication
- type 2 diabetes
- Duration
- 40 weeks
- ClinicalTrials.gov
- NCT05971940
- Sponsor
- Eli Lilly
Notes
ACHIEVE-1 (Rosenstock et al, NEJM 2025), Phase 3 early-T2D: 36 mg HbA1c ~-1.5% at week 40 (treatment-regimen; ~-1.6% efficacy estimand), baseline 8.0%, reductions of 1.3-1.6% across 3/12/36 mg. No food/water restriction - first oral small-molecule GLP-1 with the convenience of a pill. Approved for obesity as Foundayo; T2D filing separate.