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RecruitingNCT07720271AMAZE 9Updated Sep 28, 2026

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

A Phase 3 interventional study of zenagamtide and Placebo in Overweight and Obesity, sponsored by Novo Nordisk A/S. Recruiting at 41 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
950
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight
  • Obesity
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
950 participants (estimated)

Study arms

  • 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.

    Drug: zenagamtide

  • 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.

    Drug: Placebo

Interventions

  • Drugzenagamtide

    zenagamtide will be taken orally.

  • DrugPlacebo

    Placebo matched to zenagamtide will be taken orally.

05

What researchers measure

Primary outcomes

  1. Relative change in body weight

    Measured as percentage (%) change in body weight.

    Time frame: From baseline (week 0) to (week 76)

Secondary outcomes

  1. Change in waist circumference

    Measured as centimetre (cm)

    Time frame: From baseline (week 0) to (week 76)

  2. Change in systolic blood pressure (SBP)

    Measured as millimetre of mercury (mmHg).

    Time frame: From baseline (week 0) to (week 76)

06

Study locations

39 of 41 sites recruiting
  • Pinnacle Research Group LLC
    Anniston, Alabama 36207, United States
    Recruiting
  • Univ of Alabama Birmingham
    Birmingham, Alabama 35294, United States
    Recruiting
  • Chambliss Clinical Trials LLC
    Montgomery, Alabama 36106, United States
    Recruiting
  • Providence Medical Foundation
    Fullerton, California 92835, United States
    Recruiting
  • Torrance Clinical Research Institute, Inc.
    Lomita, California 90717, United States
    Recruiting
  • Diablo Clinical Research, Inc.
    Walnut Creek, California 94598, United States
    Recruiting
  • Univ of Colorado at Denver
    Aurora, Colorado 80045, United States
    Recruiting
  • Brain Matters Research
    Delray Beach, Florida 33445, United States
    Recruiting
  • Northeast Research Institute
    Fleming Island, Florida 32003, United States
    Recruiting
  • Miguel Rebollar PA
    Hialeah, Florida 33012, United States
    Recruiting
  • Jacksonville Ctr Clin Res
    Jacksonville, Florida 32216, United States
    Recruiting
  • South Broward Research LLC
    Miramar, Florida 33027, United States
    Recruiting
  • Clinical Neuroscience Solution
    Orlando, Florida 32801, United States
    Recruiting
  • Florida Institute for Clinical Research, LLC
    Orlando, Florida 32825, United States
    Recruiting
  • Oviedo Medical Research, LLC
    Oviedo, Florida 32765, United States
    Recruiting
  • Hope Clin Res & Wellness
    Conyers, Georgia 30094, United States
    Recruiting
  • East West Medical Research Institute_Honolulu
    Honolulu, Hawaii 96814, United States
    Recruiting
  • Great Lakes Clinical Trials
    Chicago, Illinois 60640, United States
    Recruiting
  • Clinical Investigation Spec Gurnee
    Gurnee, Illinois 60031, United States
    Recruiting
  • Endeavor Health
    Skokie, Illinois 60077, United States
    Recruiting
  • Evanston Premier Hlthcr Res
    Skokie, Illinois 60077, United States
    Recruiting
  • Midwest Inst For Clin Res
    Indianapolis, Indiana 46260, United States
    Not yet recruiting
  • Northern Pines Hlth Ctr, PC
    Buckley, Michigan 49620, United States
    Recruiting
  • StudyMetrix Research LLC
    City of Saint Peters, Missouri 63303, United States
    Recruiting
  • Palm Research Center Inc.
    Las Vegas, Nevada 89128, United States
    Recruiting
  • Comprehensive Weight Ctrl Prog
    New York, New York 10021, United States
    Recruiting
  • Medication Mgmnt, LLC_Grnsboro
    Greensboro, North Carolina 27401, United States
    Recruiting
  • Accellacare of Raleigh
    Raleigh, North Carolina 27609, United States
    Recruiting
  • Accellacare-Salisbury PMG Res
    Salisbury, North Carolina 28144, United States
    Recruiting
  • Accellacare and KDCILM, LLC
    Wilmington, North Carolina 28401, United States
    Recruiting
  • Lynn Institute of Norman
    Norman, Oklahoma 73072, United States
    Recruiting
  • Clinical Res Collaborative
    Cumberland, Rhode Island 02864, United States
    Recruiting
  • Medical Uni of SC Charleston
    Charleston, South Carolina 29425, United States
    Recruiting
  • Coastal Carolina Research Ctr
    North Charleston, South Carolina 29405, United States
    Recruiting
  • Hillcrest Clinical Research
    Simpsonville, South Carolina 29681-1538, United States
    Recruiting
  • Spartanburg Medical Research
    Spartanburg, South Carolina 29303, United States
    Recruiting
  • Amarillo Medical Specialists
    Amarillo, Texas 79124, United States
    Recruiting
  • North Texas Endocrine Center
    Dallas, Texas 75231, United States
    Recruiting
  • Washington Cntr Weight Mgmt
    Arlington, Virginia 22206, United States
    Not yet recruiting
  • Health Res of Hampton Roads
    Newport News, Virginia 23606, United States
    Recruiting
  • National Clin Res Inc.
    Richmond, Virginia 23294, United States
    Recruiting
07

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07720271
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jul 22, 2026
Start date
Aug 31, 2026
Primary completion
Jun 27, 2028 (estimated)
Completion
Aug 22, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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