Science

Novo Nordisk starts Phase 3 AMAZE-12 trial of amycretin for weight maintenance

Amycretin is now in late-stage testing for keeping weight off after dieting, but no results or approval timeline have been disclosed, so nothing changes for US patients today.

By the Semaglutides news desk·

Novo Nordisk launched a Phase 3 trial of amycretin in May 2026, moving the investigational drug into late-stage testing for weight management [1]. The study is called AMAZE-12, and its stated purpose is post-diet weight maintenance rather than initial weight loss [1].

Amycretin is described as a GLP-1/amylin molecule, and the drug is also listed under the name zenagamtide [1]. Novo is one of several companies investing in the amylin pathway, which the same tracking page lists alongside CagriSema and petrelintide among the most active areas of obesity drug development [1]. Novo also announced a United Arab Emirates logistics hub in May 2026 [1].

What is and is not known about AMAZE-12

The number of participants, the trial's length, its endpoints, the doses being tested and the dosing format have not been reported [1]. No weight-loss result for amycretin appears in the tracker's data [1]. The tracker does not list a projected readout date or an FDA submission plan for amycretin [1].

The maintenance focus sets AMAZE-12 apart from the late-stage programs that report weight-loss percentages. One related Phase 3 result appeared on May 12, 2026, from a trial called ATTAIN-MAINTAIN, which tested Foundayo (orforglipron) combined with lower-dose Zepbound (tirzepatide) after patients stepped down from Wegovy; participants regained roughly 0.9 to 5 kilograms depending on the group [1].

Where amycretin sits in the current landscape

Four obesity drugs are FDA approved as of May 2026, according to the tracker: Wegovy injectable (semaglutide, June 2021), the Wegovy pill (semaglutide, December 22, 2025), Zepbound (tirzepatide, November 2023) and Foundayo (orforglipron, April 1, 2026) [1]. Reported weight loss was about 15% for Wegovy injectable in STEP 1, about 17% for the oral Wegovy in OASIS 4, about 22.5% for Zepbound in SURMOUNT-1 and 12.4% at 72 weeks for Foundayo [1].

CagriSema remains the closest pending FDA decision. Its application was filed December 18, 2025, and Novo's guidance points to a US decision window in the fourth quarter of 2026, with no public PDUFA date [1]. In a head-to-head Phase 3 trial reported February 23, 2026, CagriSema failed to match tirzepatide, with 20.2% versus 23.6% weight loss at 84 weeks [1].

Retatrutide, a Lilly drug, reported 28.3% weight loss at 80 weeks on 12 mg in the TRIUMPH-1 trial on May 21, 2026, with 45.3% of participants reaching at least 30% loss and an 11.3% discontinuation rate on 12 mg; no application has been filed [1]. Survodutide, from Boehringer Ingelheim and Zealand, reported 16.6% at 76 weeks in SYNCHRONIZE-1 in May 2026 [1].

Why it matters for patients

Nothing about the amycretin news changes what is available in a US pharmacy. Amycretin is investigational, and the tracker lists no approval filing, no efficacy data and no safety data for it [1]. Even if the trial proceeds smoothly, late-stage testing followed by an FDA review typically takes years, and Novo has not disclosed a timeline [1].

For people already taking semaglutide or tirzepatide, the more immediately relevant item on the page is the research into what happens after treatment changes. The ATTAIN-MAINTAIN result is a Phase 3 look at weight regain after a step-down from Wegovy, which is the same practical question AMAZE-12 is designed to study in a different way [1]. Patients considering a change in medication have a growing but still limited body of late-stage evidence to discuss with a clinician; amycretin is not part of that evidence yet [1].

What happens next

No date has been reported for AMAZE-12 results [1]. Novo's guidance points to a US decision on CagriSema in the fourth quarter of 2026, without a public PDUFA date [1]. Readouts from TRIUMPH-2, which tests retatrutide in type 2 diabetes, and TRIUMPH-3, which tests it in cardiovascular disease, are still expected in 2026 [1]. Lilly's guidance has pointed to a possible 2026 FDA submission for retatrutide and a launch around 2027, but no filing had been confirmed as of July 2026 [1].

Sources

  1. https://remypeptides.com/research/obesity-drug-approval-tracker-2026

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