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Efficacy and safety of NNC0487-0111 s.c. once-weekly in Japanese participants with overweight or obesity (AMAZE 10) (NN9490-8088) (AMAZE 10)

AMAZE 10: A research study investigating how well the medicine NNC0487-0111 helps people in Japan with excess body weight lose weight (AMAZE 10)

Tsukasaki Nobuaki

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

JPHC_clinical_trials@novonordisk.com

Clinical trail information Administorator

Novo Nordisk Pharma Ltd.

2-1-1, Marunouchi, Chiyodaku, Tokyo

+81-3-6266-1000

JPHC_clinical_trials@novonordisk.com

Recruiting

Sept. 14, 2026

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

1. Male or female (sex at birth).
2. 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 in addition to criteria 1, 2 (above):
3. Diagnosed with T2D >= 180 days before screening.
4. Haemoglobin A1c (HbA1c) 7.0 -10.0% (53-86 mmol/mol) (both inclusive) as measured by the central laboratory at screening.
5. Treatment with lifestyle intervention, and/or with 0-3 marketed oral antidiabetic drugs (OADs) (metformin, glinide, thiazolidinedione, sodium-glucose cotransporter-2 inhibitors, alpha 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 50participants), the following inclusion criteria apply in addition to criteria 6-8 (above):
6. Clinical diagnosis of knee OA (American College ofRheumatology 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 dominantleg.
7. Symptomatic knee OA with first appearance of pain in the targetknee > 90 days prior to screening and pain in the target knee for > 15days over the prior 30 days.
8. Willingness to complete a 72-hour washout period of analgesicsbefore 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).

1. Treatment with glucagon-like-peptide-1 (GLP-1) receptoragonists (RA), dual GLP-1/gastric inhibitory peptide (GIP) RAs (or anyother GLP-1 based treatment) or amylin analogues before screening.
For participants without T2D at screening (including participants withand without knee OA), the following exclusion criteria apply inaddition to criterion 1 (above):
2. HbA1c >= 6.5% (48 mmol/mol) as measured by the centrallaboratory at screening.
3. History of type 1 or type 2 diabetes mellitus.
For participants with T2D at screening, the following exclusioncriteria apply in addition to criterion 1 (above):
4. Known hypoglycaemic unawareness as indicated by theinvestigator according to Clarkes questionnaire question 8.
5. Recurrent severe hypoglycaemic episodes within the last year asjudged by the investigator.
6. Renal impairment with estimated Glomerular Filtration Rate(eGFR) < 30 millilitre per minute per 1.73 m2, (2021 Chronic KidneyDisease Epidemiology Collaboration (CKD-EPI) formula (bycreatinine)), at screening.
7. Participant with diabetic retinopathy or maculopathy whoreceived treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 daysbefore screening or are expected to require treatment within 180days after screening. Diabetic retinopathy or maculopathy must be verified by an eyeexamination per-formed within 90 days before screening or in theperiod between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using adigital fundus photography camera specified for non-dilatedexamination.
For participants with knee OA, the following exclusion criteria apply inaddition to criterion1 (above):
8. Any joint prosthesis or joint replacement in the target knee.
9. Arthroscopy or injections into the target knee within the last 90days prior to screening.
10. Any other joint disease in the target knee including gout andpseudogout.

Both

Overweight and obesity

Participants will be randomized to receive either NNC0487-0111 or placebo.
Study treatment will be administered once weekly by subcutaneous injection.
Injection sites: thigh, abdomen, or upper arm.

Relative change in body weight from baseline (week 0) to end of treatment (week 84)

+81-42-648-5551

June. 05, 2026

Yes

According to the Novo Nordisk disclosure commitment onnovonordisk-trials.com

NA