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RecruitingNCT07668414AMAZE 7Updated Sep 28, 2026

A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide

A Phase 3 interventional study of Zenagamtide and Semaglutide in Overweight and Obesity, sponsored by Novo Nordisk A/S. Recruiting at 45 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
650
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

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 years or above at the time of signing the informed consent.

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

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

Study arms

  • Experimental
    Zenagamtide

    Participants will receive Zenagamtide and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

    Drug: Zenagamtide · Drug: Placebo (matched to semaglutide)

  • Active comparator
    Semaglutide dose 1

    Participants 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.

    Drug: Semaglutide · Drug: Placebo (matched to zenagamtide)

  • Active comparator
    Semaglutide dose 2

    Participants 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.

    Drug: Semaglutide · Drug: Placebo (matched to zenagamtide)

Interventions

  • DrugZenagamtide

    Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • DrugSemaglutide

    Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • DrugPlacebo (matched to semaglutide)

    Placebo matched to semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • DrugPlacebo (matched to zenagamtide)

    Placebo matched to zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

05

What researchers measure

Primary outcomes

  1. Relative change in body weight

    Measured as percentage (%) change in body weight.

    Time frame: From week 0 to week 84

Secondary outcomes

  1. Change in waist circumference

    Measured as centimetre (cm).

    Time frame: From week 0 to week 84

06

Study locations

33 of 45 sites recruiting
  • First Valley Medical Group
    Lancaster, California 93534, United States
    Recruiting
  • Desert Oasis Healthcare
    Palm Springs, California 92262, United States
    Recruiting
  • Western University of Health Sciences
    Pomona, California 91766, United States
    Recruiting
  • Artemis Insitute for Clin Res
    San Diego, California 92123, United States
    Recruiting
  • Med Home Development Grp
    Washington D.C., District of Columbia 20037, United States
    Recruiting
  • Encore Medical Research LLC
    Hollywood, Florida 33024, United States
    Recruiting
  • NextPhase Research
    Hollywood, Florida 33024, United States
    Recruiting
  • Jacksonville Ctr Clin Res
    Jacksonville, Florida 32216, United States
    Not yet recruiting
  • PharmaDev Clinical Research Institute LLC
    Miami, Florida 33176, United States
    Recruiting
  • South Broward Research LLC
    Miramar, Florida 33027, United States
    Recruiting
  • Essence MD Research
    Naples, Florida 34102, United States
    Not yet recruiting
  • Florida Inst For Clin Res LLC
    Orlando, Florida 32825, United States
    Recruiting
  • Oviedo Medical Research, LLC
    Oviedo, Florida 32765, United States
    Recruiting
  • Palm Beach Research Center
    West Palm Beach, Florida 33409, United States
    Recruiting
  • Encore Medical Research of Weston
    Weston, Florida 33331, United States
    Recruiting
  • Conquest Research
    Atlanta, Georgia 30328, United States
    Recruiting
  • Eastside Bariatric and Gen Surg
    Snellville, Georgia 30078, United States
    Recruiting
  • Chicago Research Center, Inc
    Chicago, Illinois 60634, United States
    Not yet recruiting
  • Endeavor Health
    Skokie, Illinois 60077, United States
    Recruiting
  • Midwest Inst For Clin Res
    Indianapolis, Indiana 46260, United States
    Recruiting
  • Southern Clin Research
    Zachary, Louisiana 70791, United States
    Not yet recruiting
  • Amicis Centers of Clinical Research
    St Louis, Missouri 63128, United States
    Recruiting
  • Ichor Research
    Syracuse, New York 13210, United States
    Recruiting
  • Southgate Medical Group, LLP
    West Seneca, New York 14224, United States
    Recruiting
  • PharmQuest Life Sciences LLC
    Greensboro, North Carolina 27408, United States
    Not yet recruiting
  • Piedmont Healthcare/Research
    Statesville, North Carolina 28625, United States
    Recruiting
  • Lillestol Research LLC
    Fargo, North Dakota 58104, United States
    Recruiting
  • Geisinger Clinic
    Danville, Pennsylvania 17822, United States
    Recruiting
  • Medical University Of South Carolina
    Charleston, South Carolina 29425, 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 Med Spec LLP
    Amarillo, Texas 79124, United States
    Recruiting
  • Texas Diabetes & Endocrinology
    Austin, Texas 78749, United States
    Recruiting
  • Pinnacle Clinical Research
    Brownsville, Texas 78520, United States
    Recruiting
  • Osvaldo A. Brusco MD
    Corpus Christi, Texas 78414, United States
    Recruiting
  • UT Southwestern Med Center
    Dallas, Texas 75390, United States
    Not yet recruiting
  • Epic Medical Research
    DeSoto, Texas 75115, United States
    Not yet recruiting
  • Houston Research Institute
    Houston, Texas 77079, United States
    Not yet recruiting
  • The Endocrine Center
    Houston, Texas 77079, United States
    Not yet recruiting
  • Sleep Therapy Research Center
    San Antonio, Texas 78229, United States
    Not yet recruiting
  • Olympus Clinical Research
    Sugar Land, Texas 77478, United States
    Not yet recruiting
  • National Clin Res Inc.
    Richmond, Virginia 23294, United States
    Recruiting
  • Gastroent Consult of SW VA
    Roanoke, Virginia 24014, United States
    Not yet recruiting
  • Rainier Clin Res Ctr Inc
    Renton, Washington 98057, United States
    Recruiting
  • Seattle Clinical Research Center
    Seattle, Washington 98104, 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
NCT07668414
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Jun 25, 2026
Start date
Sep 22, 2026
Primary completion
Oct 10, 2028 (estimated)
Completion
Oct 10, 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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