Novo Nordisk begins first Phase 3 trial of zenagamtide and registers two more
Zenagamtide's Phase 3 program is moving forward, with one large diabetes trial now enrolling and two obesity studies set to start in September, though no results are expected soon.
Novo Nordisk has started enrolling the first Phase 3 trial of zenagamtide, an experimental medicine, and has registered two more late-stage studies of the drug [1][2][3].
The enrolling study is called AMBITION 7. Its registration lists a planned enrollment of 1,778 people with type 2 diabetes who also have an increased risk of diseases affecting the heart and blood vessels, and who are already being treated with one to three other diabetes medications [1]. Participants will receive either zenagamtide or insulin glargine, an injectable insulin used to lower blood sugar [1]. The study is designed to measure how well each treatment lowers blood sugar and body weight [1]. The record lists the trial as accepting participants [1].
The two newly registered studies focus on weight rather than diabetes. AMAZE 7 is described as a comparison of zenagamtide with semaglutide — the molecule in Ozempic, Wegovy and Rybelsus — in people with excess body weight [2]. That makes it a direct test against an already approved GLP-1 medicine in the same class of conditions. The third study, AMAZE 9, tests zenagamtide in tablet form in people with excess body weight [3]. Both AMAZE 7 and AMAZE 9 are listed with planned start dates in September 2026 [2][3].
Several details have not been disclosed. The records do not state how many people the two AMAZE studies aim to enroll, how long any of the three trials will run, what doses are being tested, or when results are expected [1][2][3]. No completion dates or timelines for seeking US Food and Drug Administration approval have been reported.
Why it matters for patients
All three trials compare zenagamtide against medicines that are already in use rather than against a placebo [1][2][3]. That design means the results, when they arrive, should show how the experimental drug stacks up directly against existing options rather than simply showing that it does something.
The semaglutide comparison in AMAZE 7 is the one most likely to draw attention from people already taking Ozempic or Wegovy for weight loss, because it puts the two molecules side by side in the same study population [2]. AMBITION 7 does something similar for type 2 diabetes, using insulin glargine as the comparison in people who are already on other diabetes medicines [1].
AMAZE 9 matters for a different reason: it tests a tablet, listed as zenagamtide tablets, in people with excess body weight [3]. Oral GLP-1 options exist but are limited, and an effective pill would offer an alternative to injections. Whether zenagamtide tablets work, and how they compare with injected forms, is not yet known.
None of this changes what is available today. Zenagamtide is not an approved medicine, and it is not yet known when or whether it might reach the US market. People who want to join a trial can find eligibility requirements on the study records, which list conditions, prior treatments and other criteria [1][2][3].
What happens next
AMBITION 7 is open and enrolling now, with 1,778 participants planned [1]. AMAZE 7 and AMAZE 9 are registered with planned start dates in September 2026 [2][3]. Enrollment targets, primary completion dates and expected reporting timelines for the two AMAZE studies have not been reported.
Sources
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