ObesityPhase 3AMAZE 13NCT07668401
AMAZE 13: A Research Study Investigating How Well the Medicine Zenagamtide Helps People in Asia With Excess Body Weight Lose Weight
A Phase 3 study testing Zenagamtide in people with Obesity and Overweight, run by Novo Nordisk A/S at 44 sites in 5 countries.
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 injections under the skin once a week. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Zenagamtide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 44 sitesin 5 countries
- Study dates
- 7 Jan 2027to 11 Jan 2029
- 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 assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent
Who cannot join
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- 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
44 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
44 sites in 5 countries
India21 sites
All India Institute of Medical Science (AIIMS), Guwahati
Assam, 781101
Madras Diabetes Research Foundation
Chennai, Tamil Nadu, 600086
Maulana Azad Medical College
Delhi, New Delhi, 110002
Karnataka Medical College and Research Institute
Hubbali, Karnataka, 580022
Diabetes Research Center, Hyderabad
Hyderabad, Telangana, 500 082
Osmania General Hospital
Hyderabad, Telangana, 500012
TOTALL Diabetes Hormone Institute
Indore, Madhya Pradesh, 452010
SMS Hospital
Jaipur, 302004
Shree Mahalaxmi DIATONE Institute
Kohlapur, Maharashtra, 416001
Excel Endocrine Centre
Kolhāpur, Maharashtra, 416008
Government Medical College, Kozhikode
Kozhikode, Kerala, 673008
BSES MG hospital
Mumbai, Maharashtra, 400058
All India Institute of Medical Sciences (AIIMS), Nagpur
Nagpur, Maharashtra, 441108
Shalini Tai Meghe Hospital and Research Center
Nagpur, Maharashtra, 441110
Vijan Hospital & Research Centre
Nashik, Maharashtra, 422005
Grant Medical Foundation Ruby Hall Clinic
Pune, Maharashtra, 411001
Chellaram Diabetes Institute
Pune, Maharashtra, 411021
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, 395002
SSG Hospital, Baroda
Vadodara, Gujarat, 390001
GMERS Medical college and hospital
Vadodara, 390021
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, 632004
South Korea7 sites
Kyungpook National University Hospital_Family Medicine
Daegu, 41944
Seoul National University Hospital_Family Medicine
Seoul, 03080
Severance Hospital, Yonsei University Health System_Family Medicine
Seoul, 03722
Konkuk University Medical Center_Endocrinology
Seoul, 05030
Seoul National University Bundang Hospital_Endocrinology
Seoungnam-si, Gyeonggi-do, 13620
Ajou University Hospital_Family Medicine
Suwon, Gyeonggi-do, 16499
Pusan National University Yangsan Hospital_Family Medicine
Yangsan, Gyeongsangnam-do, 50612
Japan6 sites
Kindai University Hospital_Department of Endocrinology, Metabolism and Diabetes
Sakai-shi, Osaka, 590-0197
Medical Corporation Shinanokai Shinanozaka Clinic_Internal Medicine
Shinjuku-ku, Tokyo, 160-0017
OCROM Clinic_Internal medicine
Suita-shi, Osaka, 565-0853
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027
Fukuwa Clinic_Internal Medicine
Tokyo, 104-0031
ToCROM Clinic_Internal Medicine
Tokyo, 160-0008
Malaysia5 sites
Hospital Canselor Tuanku Muhriz UKM
Cheras, Kuala Lumpur, 56000
University Malaya Medical Centre
Lembah Pantai, Kuala Lumpur, 59100
Hospital Melaka
Malacca, 75400
Hospital Miri
Miri, Sarawak, 98000
Hospital Putrajaya
Putrajaya, 62250
Thailand5 sites
Ramathibodi Hospital
Bangkok, 10400
Siriraj Institute of Clinical Research
Bangkok, 10700
Maharaj Nakorn Chiang Mai
Chiang Mai, 50200
Thammasat Hospital_CRC
Pathum Thani, 12120
Songklanagarind Hospital
Songkhla, 90110
About this study
Official title: Efficacy and Safety of Zenagamtide s.c. Once-weekly in Asian Participants With Overweight or Obesity (AMAZE 13)
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 injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.
- Conditions
- Obesity, Overweight
- Being tested
- Zenagamtide, Placebo ( matched to Zenagamtide)
- Medical subject headings
- Obesity, Overweight
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 PDS290 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 PDS290 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 be randomized to receive 1 out of 3 different dose levels subcutaneously once weekly. Receives: Drug: Zenagamtide |
| Placebo | Placebo comparator | Participants will receive placebo matched to Zenagamtide subcutaneously once weekly. Receives: 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 of body weight.
Measured: From baseline (week 0) to week 80
Secondary outcomes (1)
Change in waist circumference
Measured as centimetre (cm).
Measured: From baseline (week 0) to week 80
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 start7 Jan 2027 (estimated)
- Primary completion11 Jan 2029 (estimated)
- Study completion11 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- 400 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
- NCT07668401
- Sponsor's protocol ID
- NN9490-8731
- Other IDs
- U1111-1335-9475
- Acronym
- AMAZE 13
- Status last verified
- Aug 2026
- First submitted
- 18 Jun 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- 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 24 Aug 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 in Asian Participants With Overweight or Obesity (AMAZE 13)
- ClinicalTrials.gov ID
- NCT07668401
- Acronym / sponsor ID
- AMAZE 13 / NN9490-8731
- Conditions
- Obesity, Overweight
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2027 (estimated)
- Primary completion
- 11 Jan 2029 (estimated)
- Study completion
- 11 Jan 2029 (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 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 injections under the skin once a week. Participants will either get zenagamtide (the treatment being tested) or placebo (a 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 out of 3 different dose levels subcutaneously once weekly. |
| Placebo | Placebo comparator | Drug: Placebo ( matched to Zenagamtide)Participants will receive placebo matched to Zenagamtide subcutaneously once weekly. |
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 assigned at birth, inclusive of all gender identities).
- Age 18 years or above at the time of signing the informed consent
Key exclusion criteria (3 listed)
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- 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 administered subcutaneously using PDS290 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 PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. | Drug | Placebo |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to week 80
Measured as percentage of body weight.
1 secondary outcome
Change in waist circumference
Time frame: From baseline (week 0) to week 80
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 24 Aug 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
44 sites in 5 countries: 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 Obesity and Overweight, run by Novo Nordisk A/S at 44 sites in 5 countries.
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: opening soon, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in India, South Korea, Japan, Malaysia, Thailand. 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 80). 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 24 Aug 2026.