Novo Nordisk Moves Amycretin Into Phase 3 Trials For Weight Management, Becomes Europe's Largest Company

Novo Nordisk A/S (NYSE:NVS) announced Thursday that it will advance subcutaneous and oral amycretin into phase 3 development in weight management.

Amycretin is developed for subcutaneous and oral administration.

The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities following end-of-phase 2 interactions for subcutaneous and oral amycretin in weight management.

Novo Nordisk plans to initiate a phase 3 development program with amycretin for adults with overweight or obesity during the first quarter of 2026.

Also Read: Novo Nordisk, Deep Apple Launch Drug Discovery Alliance For Weight Loss Oral Therapies

Oral Amycretin Phase 1 trial evaluated the single-ascending dose and multiple-ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.

The Subcutaneous Amycretin Phase 1b/2a trial investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in overweight or obese people.

The trial was a combined single ascending dose, multiple ascending dose, and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.

When evaluating the effects of treatment if all people adhered to treatment from a mean baseline body weight of 92.7 kg, people treated with amycretin achieved an estimated body weight loss of 9.7% on 1.25mg (20 weeks), 16.2% on 5mg (28 weeks) and 22.0% on 20mg (36 weeks).

People treated with a placebo experienced an estimated 1.9%, 2.3%, and 2.0% body weight gain, respectively.

After the update, Novo Nordisk again became the largest European company by market capitalization.

According to Benzinga Pro, Novo Nordisk’s market capitalization was $360.14 billion, compared with $351.9 billion for SAP SE (NYSE:SAP).

Since reaching a record high in June 2024, Novo has suffered a series of setbacks, including disappointing clinical trial results for its experimental obesity treatments and mounting competition from its U.S. rival, Eli Lilly And Co (NYSE:LLY).

In May, the drugmaker decided to replace chief executive officer Lars Fruergaard Jorgensen. A search for a new CEO is ongoing.

Year to date, Novo Nordisk stock has fallen around 5.5%. In the past year, the stock has plunged approximately 43%.

Price Action: NVO stock is down 0.57% at $80.59 at the last check on Friday.

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