Novo Nordisk moves amycretin, a single-molecule GLP-1 plus amylin agonist, to Phase 3

Novo Nordisk announced on June 12, 2025 that it will move amycretin, an experimental obesity drug, straight into Phase 3 testing in both a once-weekly injection and a once-daily pill ^[3][4]. The company said the late-stage trials could begin in early 2026, specifically the first quarter ^[3][4]. Results from the two early-phase studies behind that decision were published in The Lancet on June 20, 2025 ^[1].

Amycretin is a single molecule that activates two receptors at once: the GLP-1 receptor, the same target as semaglutide (Ozempic, Wegovy, Rybelsus), and the amylin receptor, a separate appetite-related pathway ^[1][3]. That differs from Novo's CagriSema, which combines two separate drugs in one dual-chamber pen ^[3]. Amycretin is not approved in the US for weight loss ^[1].

What the trials showed

The injectable study was a randomized, placebo-controlled Phase 1b/2a trial run at a single research center in San Antonio, Texas, between September 15, 2023 and April 24, 2024 ^[2]. It enrolled 125 adults aged 18 to 55 with a body mass index of 27.0 to 39.9 and an HbA1c below 6.5%; 101 received amycretin and 24 received placebo ^[1][2]. Mean starting body weight ranged from 88.3 to 99.1 kg across the multiple-dose parts ^[2].

Average weight change from baseline was significantly greater with amycretin than placebo in every dosing group: −24.3% versus −1.1% at week 36 with the 60 mg escalation arm, −22.0% versus +1.9% at week 36 with 20 mg, −16.2% versus +2.3% at week 28 with 5 mg, and −9.7% versus +2.0% at week 20 with 1.25 mg ^[2]. Some coverage described the top result as "up to 22%" over 36 weeks, citing the dose-response portion rather than the 60 mg dose-escalation arm ^[3][4].

The most common side effects were gastrointestinal, and most were mild to moderate and resolved by the end of the study ^[1][2]. Side effects became more frequent as doses went up ^[1]. The published abstract also notes that a large number of participants withdrew from the trial, with a high proportion of those discontinuations happening for reasons unrelated to side effects ^[2].

The oral study was a Phase 1 trial in 144 adults with overweight or obesity, testing single and multiple ascending doses for up to 12 weeks, at levels up to 2 times 50 mg ^[1]. In an exploratory analysis, people taking 100 mg a day lost an average of 13.1% of body weight versus 1.2% on placebo after 12 weeks ^[1]. The most common side effects were nausea, vomiting and decreased appetite, most often at higher doses ^[1]. Novo said no weight-loss plateau was seen by the end of either trial ^[1].

Why it matters for patients

These are early, small studies whose main purpose was safety, tolerability and drug levels in the body, not proving long-term weight loss ^[1][2]. The numbers come from roughly 100 people on the injection and a similarly small oral study, and the high dropout rate in the injectable trial is a real limitation when interpreting the averages ^[2]. Bigger Phase 3 trials are what determine whether the effect holds up, who tolerates the drug, and what happens over a year or more.

If amycretin succeeds, it would add a second option that pairs GLP-1 with amylin, and it would come in both injectable and pill form ^[1][3]. That could matter for people who prefer not to inject, though nothing about pricing, insurance coverage or availability is known yet.

For context, Novo's rival Eli Lilly markets tirzepatide (Mounjaro, Zepbound), and several companies including Roche, AbbVie, Metsera and Lilly are pursuing amylin-targeting drugs of their own ^[3]. Novo's CagriSema disappointed in a Phase 3 trial, and an oral form of Wegovy was under FDA review at the time of the announcement ^[3].

What happens next

Novo plans to start Phase 3 trials in adults with overweight or obesity in the first quarter of 2026, after a positive end-of-Phase 2 meeting with regulators ^[3][4]. The company said it would share details of the Phase 3 program later ^[4]. GlobalData projects potential US approval in the fourth quarter of 2030 and EU approval in the first quarter of 2031 if the trials succeed — a forecast, not a regulatory decision ^[4].