What this study is
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.
What's being tested
- zenagamtide
Intervention · DRUG
zenagamtide will be taken orally.
- Placebo
Intervention · DRUG
Placebo matched to zenagamtide will be taken orally.
Study details
- Official title
- Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)
- Sponsor
- Novo Nordisk A/S
- Conditions
- Overweight · Obesity
- Enrolling
- 950 people
- Starts
- 2026-08-31
- Est. completion
- 2028-08-22
- Design
- Quadruple-blind, randomized, parallel groups, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Male or female (sex at birth).
- Age 18 and older (both inclusive) at time of signing the informed consent.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (41)
41 openPinnacle Research Group LLC
Anniston, Alabama, United States
RecruitingUniv of Alabama Birmingham
Birmingham, Alabama, United States
RecruitingChambliss Clinical Trials LLC
Montgomery, Alabama, United States
RecruitingProvidence Medical Foundation
Fullerton, California, United States
RecruitingTorrance Clinical Research Institute, Inc.
Lomita, California, United States
RecruitingDiablo Clinical Research, Inc.
Walnut Creek, California, United States
RecruitingUniv of Colorado at Denver
Aurora, Colorado, United States
RecruitingBrain Matters Research
Delray Beach, Florida, United States
RecruitingNortheast Research Institute
Fleming Island, Florida, United States
RecruitingMiguel Rebollar PA
Hialeah, Florida, United States
RecruitingJacksonville Ctr Clin Res
Jacksonville, Florida, United States
RecruitingSouth Broward Research LLC
Miramar, Florida, United States
RecruitingClinical Neuroscience Solution
Orlando, Florida, United States
RecruitingFlorida Institute for Clinical Research, LLC
Orlando, Florida, United States
RecruitingOviedo Medical Research, LLC
Oviedo, Florida, United States
RecruitingHope Clin Res & Wellness
Conyers, Georgia, United States
RecruitingEast West Medical Research Institute_Honolulu
Honolulu, Hawaii, United States
RecruitingGreat Lakes Clinical Trials
Chicago, Illinois, United States
RecruitingClinical Investigation Spec Gurnee
Gurnee, Illinois, United States
RecruitingEndeavor Health
Skokie, Illinois, United States
RecruitingEvanston Premier Hlthcr Res
Skokie, Illinois, United States
RecruitingMidwest Inst For Clin Res
Indianapolis, Indiana, United States
Not yet recruitingNorthern Pines Hlth Ctr, PC
Buckley, Michigan, United States
RecruitingStudyMetrix Research LLC
City of Saint Peters, Missouri, United States
RecruitingPalm Research Center Inc.
Las Vegas, Nevada, United States
RecruitingComprehensive Weight Ctrl Prog
New York, New York, United States
RecruitingMedication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, United States
RecruitingAccellacare of Raleigh
Raleigh, North Carolina, United States
RecruitingAccellacare-Salisbury PMG Res
Salisbury, North Carolina, United States
RecruitingAccellacare and KDCILM, LLC
Wilmington, North Carolina, United States
RecruitingLynn Institute of Norman
Norman, Oklahoma, United States
RecruitingClinical Res Collaborative
Cumberland, Rhode Island, United States
RecruitingMedical Uni of SC Charleston
Charleston, South Carolina, United States
RecruitingCoastal Carolina Research Ctr
North Charleston, South Carolina, United States
RecruitingHillcrest Clinical Research
Simpsonville, South Carolina, United States
RecruitingSpartanburg Medical Research
Spartanburg, South Carolina, United States
RecruitingAmarillo Medical Specialists
Amarillo, Texas, United States
RecruitingNorth Texas Endocrine Center
Dallas, Texas, United States
RecruitingWashington Cntr Weight Mgmt
Arlington, Virginia, United States
Not yet recruitingHealth Res of Hampton Roads
Newport News, Virginia, United States
RecruitingNational Clin Res Inc.
Richmond, Virginia, United States
Recruiting
Study team
Sponsor
Novo Nordisk A/S
Study ID NN9487-8023
Study director
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.