OverweightPhase 3AMAZE 10NCT07822061
AMAZE 10: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People in Japan With Excess Body Weight Lose Weight
A Phase 3 study testing NNC0487-0111 in people with Overweight and Obesity, run by Novo Nordisk A/S at 26 sites in Japan.
Trial summary
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people with excess body weight and to compare its effects with placebo. Participants will receive either NNC0487-0111, the treatment being tested, or placebo, a treatment with no active medicine. 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?
- NNC0487-0111
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 26 sitesJapan
- Study dates
- 7 Sep 2026to 5 Feb 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 at birth).
- Age 18 years or above at the time of signing the informed consent.
- For participants with T2D at screening (max 25%), the following inclusion criteria apply
- Diagnosed with T2D ≥ 180 days before screening.
- Haemoglobin A1c (HbA1c) 7.0 -10.0% (53-86 millimole per mole (mmol/mol) (both inclusive) as measured by the central laboratory at screening.
- Treatment with lifestyle intervention, and/or with 0-3 marketed oral antidiabetic drugs (OADs) (Metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors, α-glucosidase inhibitors, imeglimin, or sulfonylureas (SU) as a single agent or in combination) according to local label. Treatment with OADs should be stable (same drug(s), dose and dosing frequency) before screening.
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- For participants with knee OA at screening (approximately 50 participants), the following inclusion criteria apply
- Clinical diagnosis of knee OA (American College of Rheumatology criteria) with radio-graphic changes (Kellgren-Lawrence grades 2 to 3 as per central reading) in the target knee. Target knee joint is defined as most symptomatic knee at screening. If pain in knees is equal, the target knee joint will be the dominant leg.
- Symptomatic knee OA with first appearance of pain in the target knee > 90 days prior to screening and pain in the target knee for > 15 days over the prior 30 days.
- Willingness to complete a 72-hour washout period of analgesics before all visits in-volving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 gram/day is allowed as rescue medication up until 24 hours before those visits).
Who cannot join
- 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.
- For participants without T2D at screening (including participants with and without knee OA), the following exclusion criteria apply in addition to criterion 1 (above):
- HbA1c ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- For participants with T2D at screening, the following exclusion criteria apply in addition to criterion 1 (above):
- Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
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- Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
- Renal impairment with estimated Glomerular Filtration Rate (eGFR) < 30 millilitre per minute per 1.73 m^2, (2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (by creatinine)), at screening.
- Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening.
- Diabetic retinopathy or maculopathy must be verified by an eye examination per-formed within 90 days before screening or in the period between screening and randomisation.
- Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
- For participants with knee OA, the following exclusion criteria apply in addition to cri-teria 1-3 (above):
- Any joint prosthesis or joint replacement in the target knee.
- Arthroscopy or injections into the target knee within the last 90 days prior to screening.
- Any other joint disease in the target knee including gout and pseudogout.
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
26 sites in 1 country
Japan26 sites, 26 recruiting
- Recruiting
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Aichi, 468-0009
- Not yet recruiting
The University of Tokyo Hospital, Diabetes and Metabolic
Bunkyo-ku, Tokyo, 113-8655
- Not yet recruiting
Tokuyama clinic_Diabetic internal medicine
Chiba, 261-0004
- Recruiting
Akaicho Clinic_Internal medicine
Chiba-shi, Chiba, 260-0804
- Recruiting
Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
Chigasaki-shi, Kanagawa, Japan, 253-0044
- Recruiting
Suidoubashi Medical Clinic_Internal Medicine
Chiyoda-ku, Tokyo, 101-0065
- Recruiting
Tokyo Asbo Clinic_Internal Medicine
Chuo-ku, Tokyo, 104-0031
- Recruiting
Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal Medicine
Fukuoka-shi, Fukuoka, 814-0165
- Recruiting
Naka Kinen Clinic_Internal medicine
Ibaraki, 311-0113
- Recruiting
Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine
Kagawa, 765-0071
- Recruiting
Takai Internal Medicine Clinic_Internal Medicine
Kamakura-shi, Kanagawa, 247 0056
- Not yet recruiting
Motomachi Takatsuka Naika Clinic_Internal Medicine
Kanagawa, 231-0023
- Not yet recruiting
Yokohama Minoru Clinic_Internal medicine
Kanagawa, 232-0064
- Not yet recruiting
Matsuba Clinic_Internal Medicine
Kawasaki-shi, Kanagawa, Japan, 212 0024
- Not yet recruiting
JCHO Kyushu Hospital_Department of Endocrinology and Metabolism
Kitakyushu-shi, Fukuoka, 806-8501
- Recruiting
Seino Internal Medicine Clinic_Internal medicine
Koriyama-shi, Fukushima, 963-8851
- Not yet recruiting
National Hospital Organization Kyoto Medical Center_Diabetic Center
Kyoto-shi, Kyoto, 612-8555
- Recruiting
The University of Osaka Hospital_Metabolic Medicine
Osaka, 565-0871
- Not yet recruiting
Morimoto Clinic_Pain Clinic
Osaka-shi, Osaka, 530-0041
- Recruiting
Shinsapporo Seiryou Hospital_General Clinical Department
Sapporo, Hokkaido, 004-0004
- Not yet recruiting
OCROM Clinic_Internal medicine
Suita-shi, Osaka, 565-0853
- Not yet recruiting
Tokyo-Eki Center-building Clinic_Internal Medicine
Tokyo, 103-0027
- Recruiting
Clinical Research Hospital Tokyo_Internal medicine
Tokyo, 160-0004
- Recruiting
ToCROM Clinic_Internal Medicine
Tokyo, 160-0008
- Not yet recruiting
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Yamato-shi, Kanagawa, 242-0004
- Recruiting
Yao Tokushukai General Hospital_Internal medicine
Yao City, Osaka, 581-0011
About this study
Official title: Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Japanese Participants With Overweight or Obesity (AMAZE 10)
The purpose of this clinical study is to find out if NNC0487-0111 is safe and effective for treating people with excess body weight and to compare its effects with placebo. Participants will receive either NNC0487-0111, the treatment being tested, or placebo, a treatment with no active medicine. Which treatment participants receive is decided by chance. NNC0487-0111 is a new medicine that doctors cannot yet prescribe, but it has been tested in humans before.
- Conditions
- Overweight, Obesity
- Being tested
- NNC0487-0111, Placebo (matched to NNC0487-0111)
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0487-0111Drug
NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen injectors to one of the body parts: thigh, abdomen or upper arm.
Placebo (matched to NNC0487-0111)Drug
Placebo matched to NNC0487-0111 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 |
|---|---|---|
| NNC0487-0111 | Experimental | Participants will receive NNC0487-0111 administered subcutaneously once weekly with one of four dose levels as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: NNC0487-0111 |
| NNC0487-0111 Placebo | Placebo comparator | Participants will receive placebo administered subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity. Receives: Drug: Placebo (matched to NNC0487-0111) |
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 84
Secondary outcomes (1)
Change in waist circumference measured according to Japan society for the Study of Obesity (JASSO) guideline
Measured as centimetre (cm).
Measured: From baseline (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 posted16 Sep 2026
- Study start7 Sep 2026
- Primary completion5 Feb 2029 (estimated)
- Study completion5 Feb 2029 (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
- 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
- NCT07822061
- Sponsor's protocol ID
- NN9490-8088
- Other IDs
- U1111-1313-7707
- Acronym
- AMAZE 10
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 16 Sep 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 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Japanese Participants With Overweight or Obesity (AMAZE 10)
- ClinicalTrials.gov ID
- NCT07822061
- Acronym / sponsor ID
- AMAZE 10 / NN9490-8088
- Conditions
- Overweight, Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2026 (actual)
- Primary completion
- 5 Feb 2029 (estimated)
- Study completion
- 5 Feb 2029 (estimated)
- First posted
- 16 Sep 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 NNC0487-0111 is safe and effective for treating people with excess body weight and to compare its effects with placebo. Participants will receive either NNC0487-0111, the treatment being tested, or placebo, a treatment with no active medicine. Which treatment participants receive is decided by chance. NNC0487-0111 is a new medicine that doctors cannot yet prescribe, but it has been tested in humans before.
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 |
|---|---|---|
| NNC0487-0111 | Experimental | Drug: NNC0487-0111Participants will receive NNC0487-0111 administered subcutaneously once weekly with one of four dose levels as an adjunct to a reduced-calorie diet and increased physical activity. |
| NNC0487-0111 Placebo | Placebo comparator | Drug: Placebo (matched to NNC0487-0111)Participants will receive placebo administered 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 (10 listed)
- Male or female (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- For participants with T2D at screening (max 25%), the following inclusion criteria apply
- Diagnosed with T2D ≥ 180 days before screening.
- Haemoglobin A1c (HbA1c) 7.0 -10.0% (53-86 millimole per mole (mmol/mol) (both inclusive) as measured by the central laboratory at screening.
Key exclusion criteria (15 listed)
- 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.
- For participants without T2D at screening (including participants with and without knee OA), the following exclusion criteria apply in addition to criterion 1 (above):
- HbA1c ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
- History of type 1 or type 2 diabetes mellitus.
- For participants with T2D at screening, the following exclusion criteria apply in addition to criterion 1 (above):
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 |
|---|---|---|
| NNC0487-0111NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen injectors to one of the body parts: thigh, abdomen or upper arm. | Drug | NNC0487-0111 |
| Placebo (matched to NNC0487-0111)Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm. | Drug | NNC0487-0111 Placebo |
Primary outcome
Relative change in body weight
Time frame: From baseline (week 0) to week 84
Measured as percentage of body weight (%).
1 secondary outcome
Change in waist circumference measured according to Japan society for the Study of Obesity (JASSO) guideline
Time frame: From baseline (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 16 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
26 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 NNC0487-0111 in people with Overweight and Obesity, run by Novo Nordisk A/S at 26 sites in Japan.
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 10 inclusion and 15 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 16 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 26 sites in Japan. 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 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 16 Sep 2026.