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NCT07822061RecruitingPhase 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)

Source: ClinicalTrials.gov · Last updated 16 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
400 (estimated)
First submitted
10 Sept 2026
Start date
7 Sept 2026
Primary completion date
5 Feb 2029
Lead sponsor
Novo Nordisk A/S
Diseases
Obesity
NCT number
NCT07822061

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 400
  • From 7 Sept 2026 to the primary completion date, 5 Feb 2029
  • 26 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • \- 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.
  • 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.
  • Arthroscopy or injections into the target knee within the last 90 days prior to screening.

Other illness

  • History of type 1 or type 2 diabetes mellitus.
  • Any other joint disease in the target knee including gout and pseudogout.

Lab values

  • HbA1c ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
  • 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.

Other

  • For participants without T2D at screening (including participants with and without knee OA), the following exclusion criteria apply in addition to criterion 1 (above):
  • 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.
  • 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.

Who the study is looking for

  • 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).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (26)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
Coordinator of this site? Confirm its status
AichiJapanRecruiting
The University of Tokyo Hospital, Diabetes and Metabolic
Coordinator of this site? Confirm its status
Bunkyo-ku, TokyoJapanNot yet recruiting
Tokuyama clinic_Diabetic internal medicine
Coordinator of this site? Confirm its status
ChibaJapanNot yet recruiting
Akaicho Clinic_Internal medicine
Coordinator of this site? Confirm its status
Chiba-shi, ChibaJapanRecruiting
Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
Coordinator of this site? Confirm its status
Chigasaki-shiJapanRecruiting
Suidoubashi Medical Clinic_Internal Medicine
Coordinator of this site? Confirm its status
Chiyoda-ku, TokyoJapanRecruiting
Tokyo Asbo Clinic_Internal Medicine
Coordinator of this site? Confirm its status
Chuo-ku, TokyoJapanRecruiting
Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal Medicine
Coordinator of this site? Confirm its status
Fukuoka-shi, FukuokaJapanRecruiting
Naka Kinen Clinic_Internal medicine
Coordinator of this site? Confirm its status
IbarakiJapanRecruiting
Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine
Coordinator of this site? Confirm its status
KagawaJapanRecruiting
Takai Internal Medicine Clinic_Internal Medicine
Coordinator of this site? Confirm its status
Kamakura-shi, KanagawaJapanRecruiting
Motomachi Takatsuka Naika Clinic_Internal Medicine
Coordinator of this site? Confirm its status
KanagawaJapanNot yet recruiting
Yokohama Minoru Clinic_Internal medicine
Coordinator of this site? Confirm its status
KanagawaJapanNot yet recruiting
Matsuba Clinic_Internal Medicine
Coordinator of this site? Confirm its status
Kawasaki-shiJapanNot yet recruiting
JCHO Kyushu Hospital_Department of Endocrinology and Metabolism
Coordinator of this site? Confirm its status
Kitakyushu-shi, FukuokaJapanNot yet recruiting
Seino Internal Medicine Clinic_Internal medicine
Coordinator of this site? Confirm its status
Koriyama-shi, FukushimaJapanRecruiting
National Hospital Organization Kyoto Medical Center_Diabetic Center
Coordinator of this site? Confirm its status
Kyoto-shi, KyotoJapanNot yet recruiting
The University of Osaka Hospital_Metabolic Medicine
Coordinator of this site? Confirm its status
OsakaJapanRecruiting
Morimoto Clinic_Pain Clinic
Coordinator of this site? Confirm its status
Osaka-shi, OsakaJapanNot yet recruiting
Shinsapporo Seiryou Hospital_General Clinical Department
Coordinator of this site? Confirm its status
SapporoJapanRecruiting
OCROM Clinic_Internal medicine
Coordinator of this site? Confirm its status
Suita-shiJapanNot yet recruiting
ToCROM Clinic_Internal Medicine
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
Tokyo-Eki Center-building Clinic_Internal Medicine
Coordinator of this site? Confirm its status
TokyoJapanNot yet recruiting
Clinical Research Hospital Tokyo_Internal medicine
Coordinator of this site? Confirm its status
TokyoJapanRecruiting
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
Coordinator of this site? Confirm its status
Yamato-shiJapanNot yet recruiting
Yao Tokushukai General Hospital_Internal medicine
Coordinator of this site? Confirm its status
Yao City, OsakaJapanRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.