OverweightPhase 3AMAZE 9NCT07720271
AMAZE 9: A Research Study Investigating How Well Zenagamtide Tablets Help People With Excess Body Weight Lose Weight
A Phase 3 study testing zenagamtide in people with Overweight and Obesity, run by Novo Nordisk A/S at 41 sites in United States.
Trial 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. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 950 participants
- Where
- 41 sitesUnited States
- Study dates
- 31 Aug 2026to 22 Aug 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 and older (both inclusive) at time of signing the informed consent.
Who cannot join
- 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.
Trial locations and contacts
41 sites in 1 country. Contact the study team or a site near you to ask about taking part.
41 sites in 1 country
United States41 sites, 41 recruiting
- Recruiting
Amarillo Medical Specialists
Amarillo, Texas, 79124
- Recruiting
Pinnacle Research Group LLC
Anniston, Alabama, 36207
- Not yet recruiting
Washington Cntr Weight Mgmt
Arlington, Virginia, 22206
- Recruiting
Univ of Colorado at Denver
Aurora, Colorado, 80045
- Recruiting
Univ of Alabama Birmingham
Birmingham, Alabama, 35294
- Recruiting
Northern Pines Hlth Ctr, PC
Buckley, Michigan, 49620
- Recruiting
Medical Uni of SC Charleston
Charleston, South Carolina, 29425
- Recruiting
Great Lakes Clinical Trials
Chicago, Illinois, 60640
- Recruiting
StudyMetrix Research LLC
City of Saint Peters, Missouri, 63303
- Recruiting
Hope Clin Res & Wellness
Conyers, Georgia, 30094
- Recruiting
Clinical Res Collaborative
Cumberland, Rhode Island, 02864
- Recruiting
North Texas Endocrine Center
Dallas, Texas, 75231
- Recruiting
Brain Matters Research
Delray Beach, Florida, 33445
- Recruiting
Northeast Research Institute
Fleming Island, Florida, 32003
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
- Recruiting
Medication Mgmnt, LLC_Grnsboro
Greensboro, North Carolina, 27401
- Recruiting
Clinical Investigation Spec Gurnee
Gurnee, Illinois, 60031
- Recruiting
Miguel Rebollar PA
Hialeah, Florida, 33012
- Recruiting
East West Medical Research Institute_Honolulu
Honolulu, Hawaii, 96814
- Not yet recruiting
Midwest Inst For Clin Res
Indianapolis, Indiana, 46260
- Recruiting
Jacksonville Ctr Clin Res
Jacksonville, Florida, 32216
- Recruiting
Palm Research Center Inc.
Las Vegas, Nevada, 89128
- Recruiting
Torrance Clinical Research Institute, Inc.
Lomita, California, 90717
- Recruiting
South Broward Research LLC
Miramar, Florida, 33027
- Recruiting
Chambliss Clinical Trials LLC
Montgomery, Alabama, 36106
- Recruiting
Comprehensive Weight Ctrl Prog
New York, New York, 10021
- Recruiting
Health Res of Hampton Roads
Newport News, Virginia, 23606
- Recruiting
Lynn Institute of Norman
Norman, Oklahoma, 73072
- Recruiting
Coastal Carolina Research Ctr
North Charleston, South Carolina, 29405
- Recruiting
Clinical Neuroscience Solution
Orlando, Florida, 32801
- Recruiting
Florida Institute for Clinical Research, LLC
Orlando, Florida, 32825
- Recruiting
Oviedo Medical Research, LLC
Oviedo, Florida, 32765
- Recruiting
Accellacare of Raleigh
Raleigh, North Carolina, 27609
- Recruiting
National Clin Res Inc.
Richmond, Virginia, 23294
- Recruiting
Accellacare-Salisbury PMG Res
Salisbury, North Carolina, 28144
- Recruiting
Hillcrest Clinical Research
Simpsonville, South Carolina, 29681-1538
- Recruiting
Endeavor Health
Skokie, Illinois, 60077
- Recruiting
Evanston Premier Hlthcr Res
Skokie, Illinois, 60077
- Recruiting
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
- Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
- Recruiting
Accellacare and KDCILM, LLC
Wilmington, North Carolina, 28401
About this study
Official title: Efficacy and Safety of Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)
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.
- Conditions
- Overweight, Obesity
- Being tested
- zenagamtide, Placebo
- 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 taken orally.
PlaceboDrug
Placebo matched to zenagamtide will be taken orally.
| Study group | Role | What they receive |
|---|---|---|
| zenagamtide | Experimental | Participants 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. Receives: Drug: zenagamtide |
| Placebo | Placebo comparator | Participants will receive placebo matched to zenagamtide orally once daily as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: Placebo |
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 baseline (week 0) to (week 76)
Secondary outcomes (2)
Change in waist circumference
Measured as centimetre (cm)
Measured: From baseline (week 0) to (week 76)
Change in systolic blood pressure (SBP)
Measured as millimetre of mercury (mmHg).
Measured: From baseline (week 0) to (week 76)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start31 Aug 2026
- Primary completion27 Jun 2028 (estimated)
- Study completion22 Aug 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
- 950 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
- NCT07720271
- Sponsor's protocol ID
- NN9487-8023
- Other IDs
- U1111-1313-7267
- Acronym
- AMAZE 9
- Status last verified
- Sep 2026
- First submitted
- 17 Jul 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 Once-daily Oral Zenagamtide in Participants With Obesity (AMAZE 9)
- ClinicalTrials.gov ID
- NCT07720271
- Acronym / sponsor ID
- AMAZE 9 / NN9487-8023
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 27 Jun 2028 (estimated)
- Study completion
- 22 Aug 2028 (estimated)
- First posted
- 22 Jul 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| zenagamtide | Experimental | Drug: zenagamtideParticipants 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 comparator | Drug: PlaceboParticipants will receive placebo matched to zenagamtide orally once daily 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 and older (both inclusive) at time of signing the informed consent.
Key exclusion criteria (3 listed)
- 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.
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 taken orally. | Drug | zenagamtide |
| PlaceboPlacebo matched to zenagamtide will be taken orally. | Drug | Placebo |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to (week 76)
Measured as percentage (%) change in body weight.
2 secondary outcomes
Change in waist circumference
Time frame: From baseline (week 0) to (week 76)
Change in systolic blood pressure (SBP)
Time frame: From baseline (week 0) to (week 76)
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
41 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 in people with Overweight and Obesity, run by Novo Nordisk A/S at 41 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 41 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. Some participants in this study may receive a placebo. 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 baseline (week 0) to (week 76)). 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.