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Amycretin Phase 2 Results 2025: Headline Outcomes

Novo Nordisk’s amycretin phase 2 results 2025 headline double-digit weight loss and broad glycemic gains in type 2 diabetes. The randomized, placebo-controlled study ran up to 36 weeks across weekly subcutaneous and daily oral regimens.

Amycretin phase 2 results 2025: headline outcomes

Amycretin achieved up to 14.5% weight loss with weekly injection by week 36, compared with 2.6% on placebo. Oral dosing reached up to 10.1% versus 2.5% on placebo. These type 2 diabetes weight loss findings were statistically significant across doses, according to available reports. Overall, the amycretin phase 2 results 2025 mark a notable advance versus placebo.

Timeline: amycretin phase 2 to phase 3 2026

Following these data, Novo Nordisk said it plans to start phase 3 trials 2026. The late-stage program will advance amycretin into pivotal studies, including in type 2 diabetes. As a result, the Novo Nordisk amycretin program moves toward registration-enabling evidence.

Study design and dosing in amycretin phase 2

The trial enrolled 448 adults with type 2 diabetes inadequately controlled on metformin, with or without an SGLT2 inhibitor. Approximately 40% used an SGLT2 inhibitor at baseline. Participants received six subcutaneous and three oral dose regimens for up to 36 weeks in a dose-finding design. Doses were given weekly by injection or once daily by mouth.

Weight loss efficacy in amycretin phase 2 at 36 weeks

Across higher doses, investigators saw no weight-loss plateau by week 36. The effect aligned with expectations for GLP-1 and amylin pathways. These results support a strong type 2 diabetes weight loss profile for the program. The data extend the headline outcomes reported in amycretin phase 2 results 2025.

Glycemic control: HbA1c improvements and targets achieved

By week 36, HbA1c fell up to 1.8% with subcutaneous dosing and up to 1.5% with oral dosing. Up to 89.1% of participants achieved HbA1c below 7%. Baseline HbA1c averaged 7.8% for the subcutaneous cohorts and 8.0% for the oral cohorts. Taken together, the program delivered notable HbA1c reduction 36 weeks alongside weight loss. These outcomes highlight the glycemic side of the amycretin phase 2 results 2025.

Safety profile in amycretin phase 2

Both formulations were generally well tolerated. Adverse events were mostly mild-to-moderate gastrointestinal, consistent with incretin and amylin agents.

How amycretin works and formulations

Amycretin is a single molecule that acts as a glp-1 and amylin agonist. The unimolecular approach is being developed as weekly subcutaneous injection and daily oral dosing. This dual-hormone strategy underpins the Novo Nordisk amycretin pipeline and its potential differentiation as a GLP-1 and amylin agonist.

What’s Next: phase 3 program and readouts

Novo Nordisk plans to begin phase 3 trials 2026, advancing amycretin into pivotal studies in type 2 diabetes. These plans build directly on the amycretin phase 2 results 2025 announced this week.