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Trial · Interventional

Not yet recruitingPhase 3Registry data

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

Short name AMAZE 13

NCTNCT07668401 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8731Other idU1111-1335-9475
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 3
Enrollment
400 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
5 countries

India, Japan, Malaysia, South Korea, Thailand

Start
7 Jan 2027 (estimated)
Primary completion
11 Jan 2029 (estimated)
Completion
11 Jan 2029 (estimated)
First posted
25 Jun 2026
Last update posted
24 Aug 2026
Conditions
Obesity · Overweight

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2027202820292030
  1. Ph 3

    AMAZE 13

    NCT07668401

    est. 7 Jan 2027 to est. 11 Jan 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • ZenagamtideDrug
  • Placebo ( matched to Zenagamtide)Drug

Arms2

  • Experimental

    Zenagamtide

    Participants will be randomized to receive 1 out of 3 different dose levels subcutaneously once weekly.

  • Placebo comparator

    Placebo

    Participants will receive placebo matched to Zenagamtide subcutaneously once weekly.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative change in body weight

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as percentage of body weight.

Secondary outcomes(1)

  1. Change in waist circumference

    Time frame · From baseline (week 0) to week 80

    Registry description

    Measured as centimetre (cm).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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.

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