AMAZE 10

RecruitingPhase 3

AMAZE 10: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People in Japan With Excess Body Weight Lose Weight

Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Japanese Participants With Overweight or Obesity (AMAZE 10)

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

Estimated enrollment

400

Study population

Obesity / overweight

Eligibility highlights

•HbA1c 7-10%

Primary endpoint

•Body weight

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07822061

Org study IDNN9490-8088

Secondary IDU1111-1313-7707World Health Organization (WHO)

Timeline

Milestones

Study start2026-09-07actual

Study first posted2026-09-16actual

Last update posted2026-09-16actual

Primary completion2029-02-05estimated

Study completion2029-02-05estimated

Assets

Investigational agents

Amycretin / zenagamtide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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.

•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).

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):

•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.

•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.

Endpoints (2)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Weight & body composition

2 endpoints

Primary/protocol endpoint

Relative change in body weight

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

percent change from baseline, improvement

Secondary/protocol endpoint

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

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.