Efficacy and Safety of NNC0487-0111 s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)

ClinicalTrials12 Mar 2026·Phase 3● 7/10i

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Overweight or Obesity, and Type 2 Diabetes (AMAZE 8)

Novo Nordisk A/S

Phase 3 trial (AMAZE 8) comparing Novo Nordisk's investigational NNC0487-0111 to semaglutide for weight loss in adults with overweight or obesity and type 2 diabetes. Targeting 1,000 participants with expected completion in December 2028, this head-to-head comparison uses body weight change as the primary endpoint. Novo Nordisk is testing a potential next-generation GLP-1 against its own approved semaglutide, suggesting confidence in superior weight loss efficacy. This positions NNC0487-0111 as a potential successor to Wegovy in the competitive obesity market.

Strategic signal

Novo is internally competing semaglutide with its next-generation candidate, signaling either patent cliff preparation or superior efficacy expectations. Direct head-to-head weight loss comparisons provide the clearest commercial differentiation for payers and prescribers in obesity treatment. If NNC0487-0111 demonstrates superior weight loss to semaglutide, Novo gains a stronger position against Eli Lilly's tirzepatide in the expanding obesity market, particularly for formulary positioning where weight loss magnitude drives coverage decisions.

GLP-1Weight lossType 2 diabetesDrug comparisonsNovo Nordisk

Original Abstract

The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people who have excess body weight and type 2 diabetes. Participant will receive 2 injections every week: an active medicine and a placebo, both taken as injections under the skin once a week. The placebo is a treatment with no active medicine in it and will be given to all participants. In addition to placebo, participants will receive either of the active medicine NNC0487-0111 (the treatment being tested) or Semaglutide (an approved and commonly prescribed treatment used as comparator). Which treatment participants get is decided by chance. | Condition(s): Obesity; Overweight; Diabetes Mellitus, Type 2 | Primary endpoint(s): Relative change in body weight | Enrollment: 1,000 (estimated) | Phase: Phase 3 | Sponsor: Novo Nordisk A/S | Expected completion: 2028-12-12 | Status: Not Yet Recruiting | Last update: 2026-03-12

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