Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with type 2 diabetes (SOLSTICE): a multicentre, phase 2b, randomised, placebo-controlled trial
Authors' conclusion
Once-daily oral elecoglipron showed reductions in glycaemia and a safety and tolerability profile consistent with the GLP-1 receptor agonist class at a similar phase of development, supporting continued development with phase 3 trials for people living with type 2 diabetes.
Study context
- Population
- Adults ≥18 years with BMI ≥23 kg/m² and T2D (HbA1c ≥7.0% to ≤10.5%; ≥6.5% to ≤10.5% in USA) on diet and exercise or metformin or SGLT2i monotherapy; 9 countries; mean age 58.4 years, baseline HbA1c 7.9%404 received ≥1 dose
- Participants
- 406 adults
- Comparison
- Oral once-daily elecoglipron vs placebo; open-label oral semaglutide
- 5 mg elecoglipronn = 38
- 15 mg elecoglipronn = 62
- 75 mg every 4-week dose escalationn = 38
- Placebon = 71reference
- Primary endpoint
- Percent change in HbA1c from baseline
- Follow-up
- 26 weeks
Methodological detailsphase 2b, double-blind, placebo-controlled, multicentre, open-label oral semaglutide comparator, Oct 8, 2024 to June 6, 2025; 863 screened
- Phase 2b
- Double-blind
- Placebo-controlled
- Multicentre
- Open-label oral semaglutide comparator
- Oct 8, 2024 to June 6, 2025; 863 screened
Primary result
As reported in the abstract
Mean change from baseline in HbA1c · week 26
5 mg elecoglipron
−0.91%
mean · 95% CI −1.25–-0.58
75 mg elecoglipron (every 2-week escalation)
−1.88%
mean · CI −2.23–-1.53
Placebo
−0.15%
mean · CI −0.42–0.12
- Range across elecoglipron doses: lowest 5 mg, highest 75 mg every 2-week escalation
- −0.91% to −1.88%
Safety
Adverse events
- Adverse events: range 63% to 87% across elecoglipron doses
Adverse events
- Most common AEs gastrointestinal: nausea, constipation, diarrhoea, vomiting
Original publication
Elecoglipron, an oral small molecule GLP-1 receptor agonist in adults with type 2 diabetes (SOLSTICE): a multicentre, phase 2b, randomised, placebo-controlled trial. Lancet. Published 8 June 2026. doi:10.
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