Novo Nordisk A/S (NYSE: NVO) has reported headline results from its phase 2 trial of amycretin in patients with type 2 diabetes, showing weight loss of up to 14.5 percent and significant reductions in HbA1c. The update, released on November 25, 2025, marks the first time amycretin has been evaluated in this patient group. As a dual GLP-1 and amylin receptor agonist, amycretin has the potential to reset the expectations for metabolic treatments, delivering outcomes that may exceed single-pathway incretin therapies.
The trial studied both once-weekly subcutaneous and once-daily oral formulations of amycretin, targeting patients whose type 2 diabetes was inadequately controlled by metformin with or without sodium-glucose cotransporter-2 (SGLT2) inhibitors. Conducted across multiple countries, the trial enrolled 448 participants who were randomized into nine different active treatment arms. The study explored six weekly injectable doses ranging from 0.4 mg to 40 mg and three oral doses of 6 mg, 25 mg, and 50 mg over a treatment duration of up to 36 weeks.
Novo Nordisk is positioning amycretin as a follow-up innovation to its blockbuster semaglutide franchise, and with data like this, the company appears poised to maintain its market dominance in GLP-1-driven diabetes and obesity therapeutics.
What were the clinical outcomes for amycretin on glycemic control in type 2 diabetes?
Amycretin delivered strong, dose-dependent reductions in HbA1c levels, validating its efficacy profile in a real-world patient subset. For subcutaneous amycretin, the mean baseline HbA1c was 7.8 percent. By week 36, the highest dose group achieved up to a 1.8 percent reduction in HbA1c, with nearly 89.1 percent of patients achieving HbA1c levels below 7 percent. Additionally, 76.2 percent reached levels at or below 6.5 percent.
Oral amycretin also demonstrated efficacy. Patients starting with a mean baseline HbA1c of 8.0 percent saw reductions of up to 1.5 percent, with 77.6 percent achieving sub-7 percent HbA1c levels and 62.6 percent achieving 6.5 percent or lower. These numbers are particularly noteworthy given the lower adherence barriers typically associated with oral agents.
By comparison, patients on placebo recorded modest HbA1c reductions of just 0.2 percent for subcutaneous and 0.4 percent for oral administration, confirming the trial’s statistical significance in favor of amycretin across all tested doses and routes. The primary endpoint, defined as change in HbA1c from baseline to week 36, was therefore met convincingly.
How did amycretin perform on weight loss and what does this mean for its market positioning?
The weight loss data reported in the phase 2 trial has drawn considerable interest from investors and clinicians alike. In patients treated with subcutaneous amycretin, mean baseline body weight was 99.2 kilograms. At week 36, the highest dose group experienced up to 14.5 percent weight reduction. Oral amycretin, starting from a mean baseline weight of 101.1 kilograms, yielded reductions of up to 10.1 percent.
Importantly, there was no plateau in weight loss observed at the 36-week mark for the highest doses, suggesting sustained or even improving efficacy over longer durations. In contrast, placebo arms registered only 2.6 percent and 2.5 percent reductions for subcutaneous and oral treatments respectively.
This durability could prove critical in amycretin’s differentiation strategy, especially when benchmarked against semaglutide or Eli Lilly and Company’s tirzepatide. While both of those agents have demonstrated impressive efficacy in clinical trials, questions have emerged around weight loss ceilings with long-term use. Amycretin may sidestep that issue through dual-pathway receptor activation, which engages both satiety and energy expenditure mechanisms.
What does the safety profile reveal about tolerability and long-term potential?
Amycretin exhibited a safety and tolerability profile consistent with other incretin and amylin-based agents. The most common adverse events were gastrointestinal in nature, including nausea and mild-to-moderate digestive discomfort. These effects were predominantly transient and non-severe, supporting the therapeutic viability of both the injectable and oral formulations.
According to Novo Nordisk’s chief scientific officer Martin Holst Lange, the company is “very encouraged” by the phase 2 data. He emphasized that amycretin is grounded in the complementary biology of GLP-1 and amylin, a pairing that could enable more holistic metabolic management. Novo Nordisk now plans to launch a comprehensive phase 3 program in 2026, targeting adults with type 2 diabetes and potentially expanding into obesity and other metabolic indications.
Why is amycretin seen as a key strategic asset in Novo Nordisk’s post-semaglutide pipeline?
Amycretin is being developed as a unimolecular, long-acting dual agonist of the GLP-1 and amylin receptors. This design enables simplified dosing schedules and a reduced treatment burden for patients, positioning it as a next-generation therapy that could address unmet needs in diabetes and obesity management.
Its development comes at a time when the metabolic therapeutics market is becoming increasingly competitive. Eli Lilly and Company’s tirzepatide and other dual-agonist candidates are already competing for share in the obesity drug segment, which is expected to exceed USD 100 billion in annual revenue over the next decade.
By offering both subcutaneous and oral delivery options, Novo Nordisk appears to be targeting flexibility in patient adherence and access. Oral formulations could appeal to new-to-therapy populations or those unwilling to initiate injectable treatments, thus expanding the addressable market. Subcutaneous formulations, on the other hand, may drive more aggressive weight loss in patients who are clinically obese or managing severe insulin resistance.
How are analysts reacting to amycretin’s clinical results and what does it mean for investors?
Novo Nordisk’s American Depositary Receipts (NYSE: NVO) have been trading near all-time highs throughout 2025, supported by sustained demand for semaglutide and increasing investor confidence in the company’s innovation pipeline. The amycretin results, while not immediately moving the stock amid broader market uncertainty, are expected to reinforce bullish sentiment as Novo Nordisk extends its dominance in the metabolic disease category.
Several institutional investors have highlighted amycretin’s dual-receptor mechanism as a meaningful evolution in drug design, noting that its GLP-1 and amylin synergy could support broader indications, including non-alcoholic fatty liver disease (NAFLD) and prediabetes, if future studies succeed. Buy-side analysts are also watching for cost-effectiveness data, particularly in the context of growing payer scrutiny on expensive biologic therapies.
The absence of a weight loss plateau at 36 weeks and the superior HbA1c results compared to placebo may help amycretin secure favorable pricing and reimbursement positioning, especially in European markets with rigorous health economics benchmarks.
What key clinical, regulatory, and competitive milestones will determine amycretin’s trajectory in 2026 and shape Novo Nordisk’s long-term metabolic strategy?
Novo Nordisk is expected to initiate phase 3 trials for amycretin in 2026, beginning with studies in adults with type 2 diabetes. These trials will likely be global in scope and may include direct comparators such as semaglutide or tirzepatide to demonstrate competitive efficacy. The company has not yet disclosed full trial designs or regulatory timelines, but announcements are expected early next year.
Future milestones will include clinical readouts in obese or overweight patients, as well as possible expansion into comorbid indications such as cardiovascular risk reduction or hepatic steatosis. The oral version of amycretin could also become a regulatory focal point, as Novo Nordisk seeks to cement its leadership in oral GLP-1 innovation following the launch of Rybelsus.
For now, amycretin represents a critical pillar in Novo Nordisk’s long-term growth narrative, offering a scientifically differentiated mechanism with both glycemic and weight-related benefits. As the market shifts from monotherapy to dual and triple agonists, amycretin may very well be the next keystone drug in Novo Nordisk’s expanding metabolic arsenal.
What are the key takeaways from Novo Nordisk’s amycretin phase 2 trial?
- Novo Nordisk’s amycretin achieved weight loss of up to 14.5% in type 2 diabetes patients after 36 weeks.
- HbA1c reductions reached up to 1.8% with subcutaneous dosing, with 89.1% of patients hitting HbA1c targets below 7%.
- Both oral and injectable formulations demonstrated statistically significant efficacy versus placebo.
- Safety profile was consistent with other incretin and amylin-based therapies, with mild to moderate GI side effects.
- Novo Nordisk plans to begin phase 3 trials in 2026, signaling confidence in amycretin’s potential.
- Analysts believe amycretin could become a strong competitor to tirzepatide in the dual-agonist obesity and diabetes market.
- No weight loss plateau was observed at 36 weeks, suggesting longer-term benefit.
- Oral amycretin could expand patient preference and accessibility options in chronic metabolic disease management.
- The dual GLP-1 and amylin agonist mechanism is seen as a novel approach that could broaden indications beyond diabetes.
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