A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide (AMAZE 7)

Novo Nordisk

Status and phase: Enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo (matched to zenagamtide); Drug: Semaglutide; Drug: Zenagamtide; Drug: Placebo (matched to semaglutide)

Study type: Interventional

Funder types: Industry

Identifiers

NCT07668414

U1111-1313-7968 (Other Identifier)

NN9490-8027

Details and patient eligibility

About

The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.

Enrollment: 650 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) ≥ 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 within 1 year before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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650 participants in 3 patient groups

Zenagamtide

Experimental group

Description:

Participants will receive Zenagamtide and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Placebo (matched to semaglutide)

Drug: Zenagamtide

Semaglutide dose 1

Active Comparator group

Description:

Participants will receive semaglutide dose 1 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Semaglutide

Drug: Placebo (matched to zenagamtide)

Semaglutide dose 2

Active Comparator group

Description:

Participants will receive semaglutide dose 2 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Semaglutide

Drug: Placebo (matched to zenagamtide)