Novo Nordisk has revealed positive Phase 2 results for amycretin, a new dual-agonist targeting GLP-1 and amylin receptors. This is the first time amycretin has been tested in people with type 2 diabetes.
What Amycretin Is?
Amycretin is a unimolecular GLP-1 and amylin receptor agonist. It is being developed in:
- Once-weekly subcutaneous form
- Once-daily oral form
Both are designed to improve glucose control and drive meaningful weight loss.
Why This Trial Matters?
Most patients still struggle to reach stable HbA1c and weight targets. A dual-pathway therapy that hits glucose, appetite, and weight could shift the treatment landscape.
Amycretin’s early data points in that direction.
Key Phase 2 Highlights
Glycemic Control
Once-weekly subcutaneous amycretin
- HbA1c drop: up to –1.8%
- HbA1c <7% achieved by 89.1%
- HbA1c ≤6.5% achieved by 76.2%
Once-daily oral amycretin
- HbA1c drop: up to –1.5%
- HbA1c <7% achieved by 77.6%
- HbA1c ≤6.5% achieved by 62.6%
Placebo comparison
- Only –0.2% (subcutaneous) and –0.4% (oral)
All results were statistically significant.
Massive Weight Loss Without a Plateau
Subcutaneous amycretin
- Up to 14.5% weight loss
- Placebo: –2.6%
Oral amycretin
- Up to 10.1% weight loss
- Placebo: –2.5%
No plateau was observed at week 36, even at higher doses.
Trial Overview at a Glance
- 448 participants with type 2 diabetes
- All were inadequately controlled on metformin, with or without SGLT2 inhibitors
- ~40% were already using SGLT2 inhibitors
- Six subcutaneous doses (0.4–40 mg weekly)
- Three oral doses (6–50 mg daily)
- Duration: up to 36 weeks
Safety Profile
Amycretin was well tolerated. Side effects were mainly gastrointestinal and mostly mild to moderate. Safety aligned with other incretin and amylin-based therapies.
The Quote That Says It All
Martin Holst Lange, CSO at Novo Nordisk:
“The data further validate the potential best-in-class profile of amycretin… We look forward to an extensive phase 3 program in 2026.”
What Happens Next?
Novo Nordisk plans to begin a phase 3 development program in 2026 for adults with type 2 diabetes. Additional indications are also being explored.
