AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight
AMAZE 9
Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)
2 other identifiers
interventional
950
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2026
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2026
CompletedFirst Posted
Study publicly available on registry
July 22, 2026
CompletedStudy Start
First participant enrolled
August 31, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 22, 2028
September 28, 2026
September 1, 2026
1.8 years
July 17, 2026
September 23, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured as percentage (%) change in body weight.
From baseline (week 0) to (week 76)
Secondary Outcomes (2)
Change in waist circumference
From baseline (week 0) to (week 76)
Change in systolic blood pressure (SBP)
From baseline (week 0) to (week 76)
Study Arms (2)
zenagamtide
EXPERIMENTALParticipants 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
PLACEBO COMPARATORParticipants will receive placebo matched to zenagamtide orally once daily as an adjunct to a reduced-calorie diet and increased physical activity.
Interventions
Eligibility Criteria
You may qualify if:
- Male or female (sex at birth).
- Age 18 and older (both inclusive) at time of signing the informed consent.
You may not qualify 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (41)
Pinnacle Research Group LLC
Anniston, Alabama, 36207, United States
Univ of Alabama Birmingham
Birmingham, Alabama, 35294, United States
Chambliss Clinical Trials LLC
Montgomery, Alabama, 36106, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
Torrance Clinical Research Institute, Inc.
Lomita, California, 90717, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Univ of Colorado at Denver
Aurora, Colorado, 80045, United States
Brain Matters Research
Delray Beach, Florida, 33445, United States
Northeast Research Institute
Fleming Island, Florida, 32003, United States
Miguel Rebollar PA
Hialeah, Florida, 33012, United States
Jacksonville Ctr Clin Res
Jacksonville, Florida, 32216, United States
South Broward Research LLC
Miramar, Florida, 33027, United States
Clinical Neuroscience Solution
Orlando, Florida, 32801, United States
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32825, United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765, United States
Hope Clin Res & Wellness
Conyers, Georgia, 30094, United States
East West Medical Research Institute_Honolulu
Honolulu, Hawaii, 96814, United States
Great Lakes Clinical Trials
Chicago, Illinois, 60640, United States
Clinical Investigation Spec Gurnee
Gurnee, Illinois, 60031, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260, United States
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303, United States
Palm Research Center Inc.
Las Vegas, Nevada, 89128, United States
Comprehensive Weight Ctrl Prog
New York, New York, 10021, United States
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27401, United States
Accellacare of Raleigh
Raleigh, North Carolina, 27609, United States
Accellacare-Salisbury PMG Res
Salisbury, North Carolina, 28144, United States
Accellacare and KDCILM, LLC
Wilmington, North Carolina, 28401, United States
Lynn Institute of Norman
Norman, Oklahoma, 73072, United States
Clinical Res Collaborative
Cumberland, Rhode Island, 02864, United States
Medical Uni of SC Charleston
Charleston, South Carolina, 29425, United States
Coastal Carolina Research Ctr
North Charleston, South Carolina, 29405, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Amarillo Medical Specialists
Amarillo, Texas, 79124, United States
North Texas Endocrine Center
Dallas, Texas, 75231, United States
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206, United States
Health Res of Hampton Roads
Newport News, Virginia, 23606, United States
National Clin Res Inc.
Richmond, Virginia, 23294, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sponsor staff involved in the clinical trial is masked according to company standard procedures
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2026
First Posted
July 22, 2026
Study Start
August 31, 2026
Primary Completion (Estimated)
June 27, 2028
Study Completion (Estimated)
August 22, 2028
Last Updated
September 28, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com