AMAZE 12: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Maintain Their Weight Loss

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Obesity

Treatments: Drug: NNC0487-0111; Drug: Placebo (matched to NNC0487-0111)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07503210

2025-523804-62 (Other Identifier)

NN9490-8559

U1111-1327-1477 (Other Identifier)

Details and patient eligibility

About

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. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.

Exclusion criteria

• Glycated haemoglobin (HbA1c) greater than or equal to ≥ 6.5% [48 millimoles per mole (mmol/mol)] as measured by the central laboratory at screening.
• History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records.
• Treatment with glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), dual GLP 1/gastric inhibitory peptide (GIP) RAs (or any other GLP-1 based treatment), or amylin analogues before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

600 participants in 2 patient groups, including a placebo group

NNC0487-0111

Experimental group

Description:

Participants will receive subcutaneous injection of NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: NNC0487-0111

Placebo

Placebo Comparator group

Description:

Participants will receive subcutaneous injection of placebo matched to NNC0487-0111 once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Placebo (matched to NNC0487-0111)