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

Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07720271

Acronym

AMAZE 9

Enrollment

950

Registered

2026-07-22

Start date

2026-09-01

Completion date

2028-08-22

Last updated

2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Obesity

Brief summary

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

DRUGzenagamtide

zenagamtide will be taken orally.

DRUGPlacebo

Placebo matched to zenagamtide will be taken orally.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

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

Secondary

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

Countries

United States

Contacts

CONTACTNovo Nordisk

clinicaltrials@novonordisk.com(+1) 866-867-7178

STUDY_DIRECTORClinical Transparency (dept. 2834)

Novo Nordisk A/S

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 26, 2026