Ireland
--:--IST
Recruiting Phase 3

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

NCT07822061 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2026-09-07
Last updated
2026-09-16

Condition(s) studied

OverweightObesity

Investigational drug(s) / intervention(s)

NNC0487-0111 →Placebo (matched to NNC0487-0111)

NNC0487-0111: NNC0487-0111 will be administered subcutaneously using PDS290 pre-filled pen injectors to one of the body parts: thigh, abdomen or upper arm.

Placebo (matched to NNC0487-0111): Placebo matched to NNC0487-0111 will be administered subcutaneously using pre- filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Relative change in body weight — From baseline (week 0) to week 84
    Measured as percentage of body weight (%).

Trial sites (26)

FacilityCityRegionStatus
Shinsapporo Seiryou Hospital_General Clinical Department Sapporo Hokkaido Recruiting
Tsuruma Kaneshiro Diabetes Clinic_Internal medicine Yamato-shi Kanagawa Not Yet Recruiting
Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine Chigasaki-shi Kanagawa, Japan Recruiting
Matsuba Clinic_Internal Medicine Kawasaki-shi Kanagawa, Japan Not Yet Recruiting
OCROM Clinic_Internal medicine Suita-shi Osaka Not Yet Recruiting
TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology Aichi Japan Recruiting
The University of Tokyo Hospital, Diabetes and Metabolic Bunkyo-ku, Tokyo Japan Not Yet Recruiting
Tokuyama clinic_Diabetic internal medicine Chiba Japan Not Yet Recruiting
Akaicho Clinic_Internal medicine Chiba-shi, Chiba Japan Recruiting
Suidoubashi Medical Clinic_Internal Medicine Chiyoda-ku, Tokyo Japan Recruiting
Tokyo Asbo Clinic_Internal Medicine Chuo-ku, Tokyo Japan Recruiting
Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal Medicine Fukuoka-shi, Fukuoka Japan Recruiting
Naka Kinen Clinic_Internal medicine Ibaraki Japan Recruiting
Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine Kagawa Japan Recruiting
Takai Internal Medicine Clinic_Internal Medicine Kamakura-shi, Kanagawa Japan Recruiting
Motomachi Takatsuka Naika Clinic_Internal Medicine Kanagawa Japan Not Yet Recruiting
Yokohama Minoru Clinic_Internal medicine Kanagawa Japan Not Yet Recruiting
JCHO Kyushu Hospital_Department of Endocrinology and Metabolism Kitakyushu-shi, Fukuoka Japan Not Yet Recruiting
Seino Internal Medicine Clinic_Internal medicine Koriyama-shi, Fukushima Japan Recruiting
National Hospital Organization Kyoto Medical Center_Diabetic Center Kyoto-shi, Kyoto Japan Not Yet Recruiting
The University of Osaka Hospital_Metabolic Medicine Osaka Japan Recruiting
Morimoto Clinic_Pain Clinic Osaka-shi, Osaka Japan Not Yet Recruiting
Tokyo-Eki Center-building Clinic_Internal Medicine Tokyo Japan Not Yet Recruiting
Clinical Research Hospital Tokyo_Internal medicine Tokyo Japan Recruiting
ToCROM Clinic_Internal Medicine Tokyo Japan Recruiting
Yao Tokushukai General Hospital_Internal medicine Yao City, Osaka Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07822061 on ClinicalTrials.gov ↗ ← All trials in Japan