Novo Advances Amycretin ;Novo Nordisk is moving ahead with late-stage development of amycretin after mid-stage clinical results in people with Type 2 diabetes. The shift represents a change from earlier plans, when the drug was viewed primarily as an obesity candidate. The company now intends to begin phase 3 studies in Type 2 diabetes next year.
The updated strategy follows phase 2 findings in 448 participants whose Type 2 diabetes was inadequately controlled on metformin, about 40% of whom were also taking an SGLT2 inhibitor. Novo began reconsidering amycretin’s role in diabetes after reviewing these data. In September, Chief Scientific Officer Martin Holst Lange told analysts it was “prudent” to evaluate the drug in diabetes, though Novo’s earlier focus had centered on obesity.
In the study, adults receiving once-weekly subcutaneous doses showed dose-dependent HbA1c reductions of up to 1.8% by Week 36, compared with a 0.2% decline in the placebo group. The mean baseline HbA1c was 7.8%. By the end of the 36-week period, 89.1% had HbA1c values below 7%, and 76.2% reached 6.5% or lower.
Another group took an oral formulation once daily. HbA1c fell by up to 1.5% in this cohort, compared with a 0.4% decrease in the placebo group. The baseline mean was 8%. By Week 36, 77.6% recorded HbA1c readings below 7%, and 62.6% reached 6.5% or lower.
Weight change was also monitored. Participants receiving the subcutaneous formulation lost up to 14.5% of body weight from a mean baseline of 99.2 kg, while placebo recipients lost 2.6%. Among oral participants, weight declined by up to 10.1% from a mean baseline of 101.1 kg, versus a 2.5% decrease in the placebo group. Novo noted that the highest subcutaneous dose group had only recently reached their maintenance dose and that weight had not yet plateaued at Week 36.
Safety findings consisted mainly of mild to moderate gastrointestinal events, consistent with expectations. Novo said the results support advancing amycretin into phase 3 studies for Type 2 diabetes. The company already has late-stage findings from CagriSema, which targets the same receptors. Lange stated that amycretin, as a single molecule, might match the safety, tolerability, and efficacy profile of CagriSema. He said amycretin could be “a very valuable offering for us because it’s one molecule.”
Novo’s shares rose more than 4% to approach 300 Danish kroner following release of the amycretin data. Analyst Evan Seigerman said the results represented a positive step for the company. Novo plans to begin late-stage trials in 2026.
Lange said in a video message that this was the first evaluation of amycretin in a Type 2 diabetes population and suggested the findings could be meaningful for people affected by the condition and related comorbidities.
Novo Advances Amycretin: Phase 3 Trial Launch for Type 2 Diabetes
Novo Advances Amycretin into phase 3 clinical trials, marking a major step forward in the development of innovative therapies for type 2 diabetes. This advancement highlights Novo’s commitment to improving treatment options for patients struggling to maintain optimal blood sugar levels.
Earlier trials showed that Novo Advances Amycretin could effectively improve glycemic control with a favorable safety profile. These results provided the confidence to progress to larger, more comprehensive phase 3 trials aimed at confirming these findings across diverse patient populations.
As Novo Advances Amycretin moves into phase 3, healthcare providers and patients are hopeful about its potential. Novo Advances Amycretin may provide an effective alternative for those who have not responded adequately to existing treatments, offering new opportunities for improved disease management.
Novo Advances Amycretin represents a strategic advancement in the diabetes therapy market. By advancing this treatment, Novo not only demonstrates leadership in innovation but also addresses unmet needs, potentially reshaping standards of care for type 2 diabetes.
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