ClinicalTrials.gg
RecruitingNCT07822061AMAZE 10Updated Sep 16, 2026

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 interventional study of NNC0487-0111 and Placebo (matched to NNC0487-0111) in Overweight and Obesity, sponsored by Novo Nordisk A/S. Recruiting at 26 sites in Japan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-16.

Primary conditionObesityRegistry: OverweightReclassifiedWhy we changed it
Registry
Overweight — the first condition term the registry derived for this study.
ClinicalTrials.gg
Obesity
Why
  1. The study's listed conditions name Obesity, a narrower term within Overweight.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2026; still recruiting 2 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
400
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 24 studies testing zenagamtide in Obesity — 17 open to participants now, 20 under way, 14 of them phase 3. zenagamtide · Obesity.

Planned enrollment
9th of 24
400 · median 360
Started
2026
with 18 others
Phase 3
14 of 24
11 open now
Primary completion
2029-02
later than 16 of 19 live
Registered
21st of 24
by date
Lead sponsor
24 of 24
Novo Nordisk A/S

Among the 24 studies testing zenagamtide in Obesity, this one is the 9th largest by planned enrollment, is one of 19 that started in 2026, is one of 14 in phase 3, reaches primary completion later than 16 of the 19 other live ones, and was the 21st registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

Browse Obesity studies →

Open to participants now

17 of the 24 studies testing zenagamtide in Obesity are open now, in 12 countries. Recruiting first, the newest first:

11 more — sign in →

By country, each count listing its studies:

All 17 open studies →

About zenagamtide

No approval found in the FDA or EMA files read. How studies give it is on its page →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 24 studies testing zenagamtide in Obesity, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Overweight
  • Obesity

Browse trials for

04

In context

Obesity Reclassified

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's planned enrollment of 400 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.

Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.

Compared within Obesity, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Overweight. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female (sex at birth).
  • Age 18 years or above at the time of signing the .
  • For participants with T2D at screening (max 25%), the following inclusion criteria apply
  • Diagnosed with T2D ≥ 180 days before screening.
  • (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.
  • 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 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).

Exclusion criteria

Exclusion Criteria:

- 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):

  • ≥ 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.
  • Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
  • Renal impairment with estimated (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.
Terms in these criteria, in plain language(4)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

HbA1c

A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.

Washout period

A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

06

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
400 participants (estimated)

Study arms

  • Experimental
    NNC0487-0111

    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.

    Drug: NNC0487-0111

  • Placebo comparator
    NNC0487-0111 Placebo

    Participants will receive placebo administered subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

    Drug: Placebo (matched to NNC0487-0111)

Interventions

  • NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen injectors to one of the body parts: thigh, abdomen or upper arm.

  • DrugPlacebo (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.

07

What researchers measure

Primary outcomes

  1. Relative change in body weight

    Measured as percentage of body weight (%).

    Time frame: 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).

    Time frame: From baseline (week 0) to week 84

08

Study locations

15 of 26 sites recruiting
  • Shinsapporo Seiryou Hospital_General Clinical Department
    Sapporo, Hokkaido 004-0004, Japan
    Recruiting
  • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
    Yamato-shi, Kanagawa 242-0004, Japan
    Not yet recruiting
  • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
    Chigasaki-shi, Kanagawa, Japan 253-0044, Japan
    Recruiting
  • Matsuba Clinic_Internal Medicine
    Kawasaki-shi, Kanagawa, Japan 212 0024, Japan
    Not yet recruiting
  • OCROM Clinic_Internal medicine
    Suita-shi, Osaka 565-0853, Japan
    Not yet recruiting
  • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
    Aichi, 468-0009, Japan
    Recruiting
  • The University of Tokyo Hospital, Diabetes and Metabolic
    Bunkyo-ku, Tokyo, 113-8655, Japan
    Not yet recruiting
  • Tokuyama clinic_Diabetic internal medicine
    Chiba, 261-0004, Japan
    Not yet recruiting
  • Akaicho Clinic_Internal medicine
    Chiba-shi, Chiba, 260-0804, Japan
    Recruiting
  • Suidoubashi Medical Clinic_Internal Medicine
    Chiyoda-ku, Tokyo, 101-0065, Japan
    Recruiting
  • Tokyo Asbo Clinic_Internal Medicine
    Chuo-ku, Tokyo, 104-0031, Japan
    Recruiting
  • Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal Medicine
    Fukuoka-shi, Fukuoka, 814-0165, Japan
    Recruiting
  • Naka Kinen Clinic_Internal medicine
    Ibaraki, 311-0113, Japan
    Recruiting
  • Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine
    Kagawa, 765-0071, Japan
    Recruiting
  • Takai Internal Medicine Clinic_Internal Medicine
    Kamakura-shi, Kanagawa, 247 0056, Japan
    Recruiting
  • Motomachi Takatsuka Naika Clinic_Internal Medicine
    Kanagawa, 231-0023, Japan
    Not yet recruiting
  • Yokohama Minoru Clinic_Internal medicine
    Kanagawa, 232-0064, Japan
    Not yet recruiting
  • JCHO Kyushu Hospital_Department of Endocrinology and Metabolism
    Kitakyushu-shi, Fukuoka, 806-8501, Japan
    Not yet recruiting
  • Seino Internal Medicine Clinic_Internal medicine
    Koriyama-shi, Fukushima, 963-8851, Japan
    Recruiting
  • National Hospital Organization Kyoto Medical Center_Diabetic Center
    Kyoto-shi, Kyoto, 612-8555, Japan
    Not yet recruiting
  • The University of Osaka Hospital_Metabolic Medicine
    Osaka, 565-0871, Japan
    Recruiting
  • Morimoto Clinic_Pain Clinic
    Osaka-shi, Osaka, 530-0041, Japan
    Not yet recruiting
  • Tokyo-Eki Center-building Clinic_Internal Medicine
    Tokyo, 103-0027, Japan
    Not yet recruiting
  • Clinical Research Hospital Tokyo_Internal medicine
    Tokyo, 160-0004, Japan
    Recruiting
  • ToCROM Clinic_Internal Medicine
    Tokyo, 160-0008, Japan
    Recruiting
  • Yao Tokushukai General Hospital_Internal medicine
    Yao City, Osaka, 581-0011, Japan
    Recruiting
09

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Feb 2029, 28 months after the start.

Of 198 industry-sponsored phase 3 interventional studies under Obesity, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 27. This study's planned 28 months is above that.

Counting every sponsor, half of 261 studies reached it within 24 months; a quarter within 18 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 10, 2026
First posted
Sep 16, 2026
StartActual
Sep 7, 2026
Primary completionEst.
Feb 5, 2029
CompletionEst.
Feb 5, 2029
Last update
Sep 16, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT07822061
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Sep 16, 2026
Start date
Sep 7, 2026
Primary completion
Feb 5, 2029 (estimated)
Completion
Feb 5, 2029 (estimated)
Last update
Sep 16, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Zenagamtide

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