A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide (AMAZE 7)

August 24, 2026 updated by: Novo Nordisk A/S

Efficacy and Safety of Zenagamtide s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Obesity (AMAZE 7)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

650

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Lancaster, California, United States, 93534
        • First Valley Medical Group
      • Palm Springs, California, United States, 92262
        • Desert Oasis Healthcare
      • Pomona, California, United States, 91766
        • Western University of Health Sciences
      • San Diego, California, United States, 92123
        • Artemis Insitute for Clin Res
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20037
        • Med Home Development Grp
    • Florida
      • Hollywood, Florida, United States, 33024
        • Encore Medical Research LLC
      • Hollywood, Florida, United States, 33024
        • NextPhase Research
      • Jacksonville, Florida, United States, 32216
        • Jacksonville Ctr Clin Res
      • Miami, Florida, United States, 33176
        • PharmaDev Clinical Research Institute LLC
      • Miramar, Florida, United States, 33027
        • South Broward Research LLC
      • Naples, Florida, United States, 34102
        • Essence MD Research
      • Orlando, Florida, United States, 32825
        • Florida Inst For Clin Res LLC
      • Oviedo, Florida, United States, 32765
        • Oviedo Medical Research, LLC
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
      • Weston, Florida, United States, 33331
        • Encore Medical Research of Weston
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Conquest Research
      • Snellville, Georgia, United States, 30078
        • Eastside Bariatric and Gen Surg
    • Illinois
      • Chicago, Illinois, United States, 60634
        • Chicago Research Center, Inc
      • Skokie, Illinois, United States, 60077
        • Endeavor Health
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Midwest Inst For Clin Res
    • Louisiana
      • Zachary, Louisiana, United States, 70791
        • Southern Clin Research
    • Missouri
      • St Louis, Missouri, United States, 63128
        • Amicis Centers of Clinical Research
    • New York
      • Syracuse, New York, United States, 13210
        • Ichor Research
      • West Seneca, New York, United States, 14224
        • Southgate Medical Group, LLP
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Lillestol Research LLC
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822
        • Geisinger Clinic
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Simpsonville, South Carolina, United States, 29681-1538
        • Hillcrest Clinical Research
      • Spartanburg, South Carolina, United States, 29303
        • Spartanburg Medical Research
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Med Spec LLP
      • Austin, Texas, United States, 78749
        • Texas Diabetes & Endocrinology
      • Brownsville, Texas, United States, 78520
        • Pinnacle Clinical Research
      • Corpus Christi, Texas, United States, 78414
        • Osvaldo A. Brusco MD
      • Dallas, Texas, United States, 75390
        • UT Southwestern Med Center
      • DeSoto, Texas, United States, 75115
        • Epic Medical Research
      • Houston, Texas, United States, 77079
        • The Endocrine Center
      • Houston, Texas, United States, 77079
        • Houston Research Institute
      • San Antonio, Texas, United States, 78229
        • Sleep Therapy Research Center
      • Sugar Land, Texas, United States, 77478
        • Olympus Clinical Research
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clin Res Inc.
      • Roanoke, Virginia, United States, 24014
        • Gastroent Consult of SW VA
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clin Res Ctr Inc
      • Seattle, Washington, United States, 98104
        • Seattle Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the informed consent.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: Placebo (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.
Drug: Zenagamtide
Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
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
Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Drug: Placebo (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.
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
Semaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Drug: Placebo (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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From week 0 to week 84
Measured as percentage (%) change in body weight.
From week 0 to week 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in waist circumference
Time Frame: From week 0 to week 84
Measured as centimetre (cm).
From week 0 to week 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 22, 2026

Primary Completion (Estimated)

October 10, 2028

Study Completion (Estimated)

October 10, 2028

Study Registration Dates

First Submitted

June 19, 2026

First Submitted That Met QC Criteria

June 19, 2026

First Posted (Actual)

June 25, 2026

Study Record Updates

Last Update Posted (Actual)

August 25, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9490-8027
  • U1111-1313-7968 (Other Identifier: Universal Trial Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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