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
Sites (26)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology Coordinator of this site? Confirm its status | Aichi | Japan | Recruiting |
| The University of Tokyo Hospital, Diabetes and Metabolic Coordinator of this site? Confirm its status | Bunkyo-ku, Tokyo | Japan | Not yet recruiting |
| Tokuyama clinic_Diabetic internal medicine Coordinator of this site? Confirm its status | Chiba | Japan | Not yet recruiting |
| Akaicho Clinic_Internal medicine Coordinator of this site? Confirm its status | Chiba-shi, Chiba | Japan | Recruiting |
| Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine Coordinator of this site? Confirm its status | Chigasaki-shi | Japan | Recruiting |
| Suidoubashi Medical Clinic_Internal Medicine Coordinator of this site? Confirm its status | Chiyoda-ku, Tokyo | Japan | Recruiting |
| Tokyo Asbo Clinic_Internal Medicine Coordinator of this site? Confirm its status | Chuo-ku, Tokyo | Japan | Recruiting |
| Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal Medicine Coordinator of this site? Confirm its status | Fukuoka-shi, Fukuoka | Japan | Recruiting |
| Naka Kinen Clinic_Internal medicine Coordinator of this site? Confirm its status | Ibaraki | Japan | Recruiting |
| Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine Coordinator of this site? Confirm its status | Kagawa | Japan | Recruiting |
| Takai Internal Medicine Clinic_Internal Medicine Coordinator of this site? Confirm its status | Kamakura-shi, Kanagawa | Japan | Recruiting |
| Motomachi Takatsuka Naika Clinic_Internal Medicine Coordinator of this site? Confirm its status | Kanagawa | Japan | Not yet recruiting |
| Yokohama Minoru Clinic_Internal medicine Coordinator of this site? Confirm its status | Kanagawa | Japan | Not yet recruiting |
| Matsuba Clinic_Internal Medicine Coordinator of this site? Confirm its status | Kawasaki-shi | Japan | Not yet recruiting |
| JCHO Kyushu Hospital_Department of Endocrinology and Metabolism Coordinator of this site? Confirm its status | Kitakyushu-shi, Fukuoka | Japan | Not yet recruiting |
| Seino Internal Medicine Clinic_Internal medicine Coordinator of this site? Confirm its status | Koriyama-shi, Fukushima | Japan | Recruiting |
| National Hospital Organization Kyoto Medical Center_Diabetic Center Coordinator of this site? Confirm its status | Kyoto-shi, Kyoto | Japan | Not yet recruiting |
| The University of Osaka Hospital_Metabolic Medicine Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Morimoto Clinic_Pain Clinic Coordinator of this site? Confirm its status | Osaka-shi, Osaka | Japan | Not yet recruiting |
| Shinsapporo Seiryou Hospital_General Clinical Department Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| OCROM Clinic_Internal medicine Coordinator of this site? Confirm its status | Suita-shi | Japan | Not yet recruiting |
| ToCROM Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Tokyo-Eki Center-building Clinic_Internal Medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Not yet recruiting |
| Clinical Research Hospital Tokyo_Internal medicine Coordinator of this site? Confirm its status | Tokyo | Japan | Recruiting |
| Tsuruma Kaneshiro Diabetes Clinic_Internal medicine Coordinator of this site? Confirm its status | Yamato-shi | Japan | Not yet recruiting |
| Yao Tokushukai General Hospital_Internal medicine Coordinator of this site? Confirm its status | Yao City, Osaka | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.