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

Novo Nordisk A/S 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 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 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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