A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide
AMAZE 7
Efficacy and Safety of Zenagamtide s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Obesity (AMAZE 7)
2 other identifiers
interventional
650
1 country
46
Brief Summary
The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with semaglutide.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2026
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 19, 2026
CompletedFirst Posted
Study publicly available on registry
June 25, 2026
CompletedStudy Start
First participant enrolled
September 22, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
October 10, 2028
Study Completion
Last participant's last visit for all outcomes
October 10, 2028
June 25, 2026
June 1, 2026
2.1 years
June 19, 2026
June 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative change in body weight
Measured as percentage (%) change in body weight.
From week 0 to week 84
Secondary Outcomes (1)
Change in waist circumference
From week 0 to week 84
Study Arms (3)
Zenagamtide
EXPERIMENTALParticipants will receive Zenagamtide and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Semaglutide dose 1
ACTIVE COMPARATORParticipants will receive semaglutide dose 1 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Semaglutide dose 2
ACTIVE COMPARATORParticipants will receive semaglutide dose 2 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Interventions
Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo matched to zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Eligibility Criteria
You may qualify if:
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
You may not qualify if:
- Glycated haemoglobin (HbA1c) ≥ 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 within 1 year before screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (46)
First Valley Medical Group
Lancaster, California, 93534, United States
Desert Oasis Healthcare
Palm Springs, California, 92262, United States
Western University of Health Sciences
Pomona, California, 91766, United States
Artemis Insitute for Clin Res
San Diego, California, 92123, United States
Med Home Development Grp
Washington D.C., District of Columbia, 20037, United States
Encore Medical Research LLC
Hollywood, Florida, 33024, United States
NextPhase Research
Hollywood, Florida, 33024, United States
Jacksonville Ctr Clin Res
Jacksonville, Florida, 32216, United States
PharmaDev Clinical Research Institute LLC
Miami, Florida, 33176, United States
South Broward Research LLC
Miramar, Florida, 33027, United States
Essence MD Research
Naples, Florida, 34102, United States
Florida Inst For Clin Res LLC
Orlando, Florida, 32825, United States
Oviedo Medical Research, LLC
Oviedo, Florida, 32765, United States
Palm Beach Research Center
West Palm Beach, Florida, 33409, United States
Encore Medical Research of Weston
Weston, Florida, 33331, United States
Conquest Research
Atlanta, Georgia, 30328, United States
Eastside Bariatric and Gen Surg
Snellville, Georgia, 30078, United States
Chicago Research Center, Inc
Chicago, Illinois, 60634, United States
Endeavor Health
Skokie, Illinois, 60077, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260, United States
Southern Clin Research
Zachary, Louisiana, 70791, United States
Amicis Centers of Clinical Research
St Louis, Missouri, 63128, United States
Ichor Research
Syracuse, New York, 13210, United States
Southgate Medical Group, LLP
West Seneca, New York, 14224, United States
University of North Carolina
Chapel Hill, North Carolina, 27514, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408, United States
Piedmont Healthcare/Research
Statesville, North Carolina, 28625, United States
Lillestol Research LLC
Fargo, North Dakota, 58104, United States
Geisinger Clinic
Danville, Pennsylvania, 17822, United States
Medical University Of South Carolina
Charleston, South Carolina, 29425, United States
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538, United States
Spartanburg Medical Research
Spartanburg, South Carolina, 29303, United States
Amarillo Med Spec LLP
Amarillo, Texas, 79124, United States
Texas Diabetes & Endocrinology
Austin, Texas, 78749, United States
Pinnacle Clinical Research
Brownsville, Texas, 78520, United States
Osvaldo A. Brusco MD
Corpus Christi, Texas, 78414, United States
UT Southwestern Med Center
Dallas, Texas, 75390, United States
Epic Medical Research
DeSoto, Texas, 75115, United States
Houston Research Institute
Houston, Texas, 77079, United States
The Endocrine Center
Houston, Texas, 77079, United States
Sleep Therapy Research Center
San Antonio, Texas, 78229, United States
Olympus Clinical Research
Sugar Land, Texas, 77478, United States
National Clin Res Inc.
Richmond, Virginia, 23294, United States
Gastroent Consult of SW VA
Roanoke, Virginia, 24014, United States
Rainier Clin Res Ctr Inc
Renton, Washington, 98057, United States
Seattle Clinical Research Center
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Interventions
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
June 19, 2026
First Posted
June 25, 2026
Study Start (Estimated)
September 22, 2026
Primary Completion (Estimated)
October 10, 2028
Study Completion (Estimated)
October 10, 2028
Last Updated
June 25, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com