AMAZE 1: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight Lose Weight

Novo Nordisk

Status and phase: Begins enrollment in 1 month; Phase 3

Conditions: Obesity

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07339423

NN9490-8021

2024-520440-42 (Other Identifier)

U1111-1313-6262 (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: 1,150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Male or female (sex at birth).
• Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
• History of at least one self-reported unsuccessful dietary effort to lose body weight.

Key Exclusion Criteria:

• HbA1c ≥ 6.5% (48 millimole 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

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1,150 participants in 2 patient groups, including a placebo group

NNC0487-0111

Experimental group

Description:

Participants will be randomized to receive 1 out of 4 different dose levels subcutaneously 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 placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Placebo (matched to NNC0487-0111)