OverweightPhase 3AMAZE 7NCT07668414
A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide
A Phase 3 study testing Zenagamtide and Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 45 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Zenagamtide and Semaglutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 650 participants
- Where
- 45 sitesUnited States
- Study dates
- 22 Sep 2026to 10 Oct 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
Who cannot join
- 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.
Trial locations and contacts
45 sites in 1 country. Contact the study team or a site near you to ask about taking part.
45 sites in 1 country
United States45 sites, 45 recruiting
- Recruiting
Amarillo Med Spec LLP
Amarillo, Texas, 79124
- Recruiting
Conquest Research
Atlanta, Georgia, 30328
- Recruiting
Texas Diabetes & Endocrinology
Austin, Texas, 78749
- Recruiting
Pinnacle Clinical Research
Brownsville, Texas, 78520
- Recruiting
Medical University Of South Carolina
Charleston, South Carolina, 29425
- Not yet recruiting
Chicago Research Center, Inc
Chicago, Illinois, 60634
- Recruiting
Osvaldo A. Brusco MD
Corpus Christi, Texas, 78414
- Not yet recruiting
UT Southwestern Med Center
Dallas, Texas, 75390
- Recruiting
Geisinger Clinic
Danville, Pennsylvania, 17822
- Not yet recruiting
Epic Medical Research
DeSoto, Texas, 75115
- Recruiting
Lillestol Research LLC
Fargo, North Dakota, 58104
- Not yet recruiting
PharmQuest Life Sciences LLC
Greensboro, North Carolina, 27408
- Recruiting
Encore Medical Research LLC
Hollywood, Florida, 33024
- Recruiting
NextPhase Research
Hollywood, Florida, 33024
- Not yet recruiting
Houston Research Institute
Houston, Texas, 77079
- Not yet recruiting
The Endocrine Center
Houston, Texas, 77079
- Recruiting
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
- Not yet recruiting
Jacksonville Ctr Clin Res
Jacksonville, Florida, 32216
- Recruiting
First Valley Medical Group
Lancaster, California, 93534
- Recruiting
PharmaDev Clinical Research Institute LLC
Miami, Florida, 33176
- Recruiting
South Broward Research LLC
Miramar, Florida, 33027
- Not yet recruiting
Essence MD Research
Naples, Florida, 34102
- Recruiting
Florida Inst For Clin Res LLC
Orlando, Florida, 32825
- Recruiting
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
- Recruiting
Desert Oasis Healthcare
Palm Springs, California, 92262
- Recruiting
Western University of Health Sciences
Pomona, California, 91766
- Recruiting
Rainier Clin Res Ctr Inc
Renton, Washington, 98057
- Recruiting
National Clin Res Inc.
Richmond, Virginia, 23294
- Not yet recruiting
Gastroent Consult of SW VA
Roanoke, Virginia, 24014
- Not yet recruiting
Sleep Therapy Research Center
San Antonio, Texas, 78229
- Recruiting
Artemis Insitute for Clin Res
San Diego, California, 92123
- Recruiting
Seattle Clinical Research Center
Seattle, Washington, 98104
- Recruiting
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538
- Recruiting
Endeavor Health
Skokie, Illinois, 60077
- Recruiting
Eastside Bariatric and Gen Surg
Snellville, Georgia, 30078
- Recruiting
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
- Recruiting
Amicis Centers of Clinical Research
St Louis, Missouri, 63128
- Recruiting
Piedmont Healthcare/Research
Statesville, North Carolina, 28625
- Not yet recruiting
Olympus Clinical Research
Sugar Land, Texas, 77478
- Recruiting
Ichor Research
Syracuse, New York, 13210
- Recruiting
Med Home Development Grp
Washington D.C., District of Columbia, 20037
- Recruiting
Palm Beach Research Center
West Palm Beach, Florida, 33409
- Recruiting
Southgate Medical Group, LLP
West Seneca, New York, 14224
- Recruiting
Encore Medical Research of Weston
Weston, Florida, 33331
- Not yet recruiting
Southern Clin Research
Zachary, Louisiana, 70791
About this study
Official title: 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.
- Conditions
- Overweight, Obesity
- Being tested
- Zenagamtide, Semaglutide, Placebo (matched to semaglutide), Placebo (matched to zenagamtide)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZenagamtideDrug
Zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
SemaglutideDrug
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)Drug
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)Drug
Placebo matched to zenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Zenagamtide | Experimental | Participants will receive Zenagamtide and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: Zenagamtide; Drug: Placebo (matched to semaglutide) |
| Semaglutide dose 1 | Active comparator | 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. Receives: Drug: Semaglutide; Drug: Placebo (matched to zenagamtide) |
| Semaglutide dose 2 | Active comparator | 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. Receives: Drug: Semaglutide; Drug: Placebo (matched to zenagamtide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative change in body weight
Measured as percentage (%) change in body weight.
Measured: From week 0 to week 84
Secondary outcomes (1)
Change in waist circumference
Measured as centimetre (cm).
Measured: From week 0 to week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2026
- Study start22 Sep 2026
- Primary completion10 Oct 2028 (estimated)
- Study completion10 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07668414
- Sponsor's protocol ID
- NN9490-8027
- Other IDs
- U1111-1313-7968
- Acronym
- AMAZE 7
- Status last verified
- Sep 2026
- First submitted
- 19 Jun 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Zenagamtide s.c. Once-weekly Compared to Semaglutide s.c. Once-weekly in Participants With Obesity (AMAZE 7)
- ClinicalTrials.gov ID
- NCT07668414
- Acronym / sponsor ID
- AMAZE 7 / NN9490-8027
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- 10 Oct 2028 (estimated)
- Study completion
- 10 Oct 2028 (estimated)
- First posted
- 25 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Zenagamtide | Experimental | Drug: Zenagamtide, Drug: Placebo (matched to semaglutide)Participants 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 comparator | Drug: Semaglutide, Drug: Placebo (matched to zenagamtide)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. |
| Semaglutide dose 2 | Active comparator | Drug: Semaglutide, Drug: Placebo (matched to zenagamtide)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ZenagamtideZenagamtide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. | Drug | Zenagamtide |
| SemaglutideSemaglutide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. | Drug | Semaglutide dose 1, Semaglutide dose 2 |
| 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 |
| 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. | Drug | Semaglutide dose 1, Semaglutide dose 2 |
Primary outcome
Relative change in body weight
Time frame: From week 0 to week 84
Measured as percentage (%) change in body weight.
1 secondary outcome
Change in waist circumference
Time frame: From week 0 to week 84
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
45 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zenagamtide and Semaglutide in people with Overweight and Obesity, run by Novo Nordisk A/S at 45 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative change in body weight (time frame: From week 0 to week 84). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.