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

Short name AMAZE 9

NCTNCT07720271Other idNN9487-8023Other idU1111-1313-7267

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 950 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 31 Aug 2026
Primary completion: 27 Jun 2028 (estimated)
Completion: 22 Aug 2028 (estimated)
First posted: 22 Jul 2026
Last update posted: 28 Sept 2026
Conditions: Overweight · Obesity

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 3
AMAZE 9
NCT07720271
31 Aug 2026 to est. 22 Aug 2028

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 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.

Interventions

zenagamtideDrug
PlaceboDrug

Arms2

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

Primary outcomes1

Outcomes the sponsor listed as primary.

Relative change in body weight
Time frame · From baseline (week 0) to (week 76)
Registry description
Measured as percentage (%) change in body weight.

Secondary outcomes(2)

Change in waist circumference
Time frame · From baseline (week 0) to (week 76)
Registry description
Measured as centimetre (cm)
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to (week 76)
Registry description
Measured as millimetre of mercury (mmHg).

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 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.

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