Testing NNC0487-0111 for weight loss in Japanese adults with overweight or obesity
Tests NNC0487-0111 against placebo in Japanese adults with overweight or obesity.
Plain-language title generated from the registry record
Registry title: AMAZE 10: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People in Japan With Excess Body Weight Lose Weight
Key facts
- Where
- Aichi, Bunkyo-ku, Tokyo, Chiba, Chiba-shi, Chiba, Chigasaki-shi, Chiyoda-ku, Tokyo, Chuo-ku, Tokyo, Fukuoka-shi, Fukuoka, Ibaraki, Kagawa, Kamakura-shi, Kanagawa, Kanagawa, Kawasaki-shi, Kitakyushu-shi, Fukuoka, Koriyama-shi, Fukushima, Kyoto-shi, Kyoto, Osaka, Osaka-shi, Osaka, Sapporo, Suita-shi, Tokyo, Yamato-shi, and Yao City, Osaka, JapanSee the 26 sites
- Phase
- Phase 3
Where in Japan
- TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and EndocrinologyAichi, JapanTaking people
- The University of Tokyo Hospital, Diabetes and MetabolicBunkyo-ku, Tokyo, JapanNot yet recruiting
- Tokuyama clinic_Diabetic internal medicineChiba, JapanNot yet recruiting
- Akaicho Clinic_Internal medicineChiba-shi, Chiba, JapanTaking people
- Hayashi Diabetes Clinic_Internal Medicine and Diabetes MedicineChigasaki-shi, JapanTaking people
- Suidoubashi Medical Clinic_Internal MedicineChiyoda-ku, Tokyo, JapanTaking people
- Tokyo Asbo Clinic_Internal MedicineChuo-ku, Tokyo, JapanTaking people
- Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal MedicineFukuoka-shi, Fukuoka, JapanTaking people
- Naka Kinen Clinic_Internal medicineIbaraki, JapanTaking people
- Iwamoto Internal Medicine Clinic_Diabetes Internal MedicineKagawa, JapanTaking people
- Takai Internal Medicine Clinic_Internal MedicineKamakura-shi, Kanagawa, JapanTaking people
- Motomachi Takatsuka Naika Clinic_Internal MedicineKanagawa, JapanNot yet recruiting
- Yokohama Minoru Clinic_Internal medicineKanagawa, JapanNot yet recruiting
- Matsuba Clinic_Internal MedicineKawasaki-shi, JapanNot yet recruiting
- JCHO Kyushu Hospital_Department of Endocrinology and MetabolismKitakyushu-shi, Fukuoka, JapanNot yet recruiting
- Seino Internal Medicine Clinic_Internal medicineKoriyama-shi, Fukushima, JapanTaking people
- National Hospital Organization Kyoto Medical Center_Diabetic CenterKyoto-shi, Kyoto, JapanNot yet recruiting
- The University of Osaka Hospital_Metabolic MedicineOsaka, JapanTaking people
- Morimoto Clinic_Pain ClinicOsaka-shi, Osaka, JapanNot yet recruiting
- Shinsapporo Seiryou Hospital_General Clinical DepartmentSapporo, JapanTaking people
- OCROM Clinic_Internal medicineSuita-shi, JapanNot yet recruiting
- Clinical Research Hospital Tokyo_Internal medicineTokyo, JapanTaking people
- ToCROM Clinic_Internal MedicineTokyo, JapanTaking people
- Tokyo-Eki Center-building Clinic_Internal MedicineTokyo, JapanNot yet recruiting
- Tsuruma Kaneshiro Diabetes Clinic_Internal medicineYamato-shi, JapanNot yet recruiting
- Yao Tokushukai General Hospital_Internal medicineYao City, Osaka, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novo Nordisk A/S
- Trial code
- NCT07822061
- Record updated
- 16 September 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of NNC0487-0111 s.c. Once-weekly in Japanese Participants With Overweight or Obesity (AMAZE 10)
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.
Inclusion: 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: 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):; 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; History of type 1 or type 2 diabetes mellitus; Any other joint disease in the target knee including gout and pseudogout; 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; 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.