AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight

ConditionsObesity Overweight

Trial statusNot yet recruiting

Trial phasePhase 3

Trial typeInterventional

Biological sexAll

Age18+

SponsorNovo Nordisk A/S

About this trial

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 injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female (sex assigned at birth, inclusive of all gender identities).

Age 18 years or above at the time of signing the informed consent

Disqualifiers

Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.

History of type 1 or type 2 diabetes mellitus.

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

Design model

Parallel

Treatments tested in this trial

Zenagamtide
Drug
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo ( matched to Zenagamtide)
Drug
Placebo matched to Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: ZenagamtideExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Relative change in body weight

Measured as percentage of body weight.

Time frame

From baseline (week 0) to week 80

Secondary outcomes

Change in waist circumference

Measured as centimetre (cm).

Time frame

From baseline (week 0) to week 80

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: