AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight

Novo Nordisk

Status and phase

Begins enrollment this month

Phase 3

Conditions

Overweight

Obesity

Treatments

Drug: zenagamtide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT07720271

NN9487-8023

U1111-1313-7267 (Other Identifier)

Details and patient eligibility

About

The purpose of this clinical study is to find out if zenagamtide is safe and effective for treating people who have excess body weight. There are 2 study treatments in this study taken as oral tablets once a day. Participants will either get zenagamtide (the treatment being tested) or Placebo (treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Enrollment

950 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female (sex at birth).
Age 18 and older (both inclusive) at time of signing the informed consent.

Exclusion criteria

Glycated haemoglobin (HbA1c) more 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

950 participants in 2 patient groups, including a placebo group

zenagamtide

Experimental group

Description:

Participants will be randomized to receive 1 of the 5 dose levels of zenagamtide orally once daily as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: zenagamtide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo matched to zenagamtide orally once daily as an adjunct to a reduced-calorie diet and increased physical activity.

Treatment:

Drug: Placebo