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

September 10, 2026 updated by: Novo Nordisk A/S

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Aichi, Japan, 468-0009
        • Recruiting
        • TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology
      • Bunkyo-ku, Tokyo, Japan, 113-8655
        • Not yet recruiting
        • The University of Tokyo Hospital, Diabetes and Metabolic
      • Chiba, Japan, 261-0004
        • Not yet recruiting
        • Tokuyama clinic_Diabetic internal medicine
      • Chiba-shi, Chiba, Japan, 260-0804
        • Recruiting
        • Akaicho Clinic_Internal medicine
      • Chiyoda-ku, Tokyo, Japan, 101-0065
        • Recruiting
        • Suidoubashi Medical Clinic_Internal Medicine
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Recruiting
        • Tokyo Asbo Clinic_Internal Medicine
      • Fukuoka-shi, Fukuoka, Japan, 814-0165
        • Recruiting
        • Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal Medicine
      • Ibaraki, Japan, 311-0113
        • Recruiting
        • Naka Kinen Clinic_Internal medicine
      • Kagawa, Japan, 765-0071
        • Recruiting
        • Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine
      • Kamakura-shi, Kanagawa, Japan, 247 0056
        • Recruiting
        • Takai Internal Medicine Clinic_Internal Medicine
      • Kanagawa, Japan, 231-0023
        • Not yet recruiting
        • Motomachi Takatsuka Naika Clinic_Internal Medicine
      • Kanagawa, Japan, 232-0064
        • Not yet recruiting
        • Yokohama Minoru Clinic_Internal medicine
      • Kitakyushu-shi, Fukuoka, Japan, 806-8501
        • Not yet recruiting
        • JCHO Kyushu Hospital_Department of Endocrinology and Metabolism
      • Koriyama-shi, Fukushima, Japan, 963-8851
        • Recruiting
        • Seino Internal Medicine Clinic_Internal medicine
      • Kyoto-shi, Kyoto, Japan, 612-8555
        • Not yet recruiting
        • National Hospital Organization Kyoto Medical Center_Diabetic Center
      • Osaka, Japan, 565-0871
        • Recruiting
        • The University of Osaka Hospital_Metabolic Medicine
      • Osaka-shi, Osaka, Japan, 530-0041
        • Not yet recruiting
        • Morimoto Clinic_Pain Clinic
      • Tokyo, Japan, 160-0008
        • Recruiting
        • ToCROM Clinic_Internal Medicine
      • Tokyo, Japan, 103-0027
        • Not yet recruiting
        • Tokyo-Eki Center-building Clinic_Internal Medicine
      • Tokyo, Japan, 160-0004
        • Recruiting
        • Clinical Research Hospital Tokyo_Internal medicine
      • Yao City, Osaka, Japan, 581-0011
        • Recruiting
        • Yao Tokushukai General Hospital_Internal medicine
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 004-0004
        • Recruiting
        • Shinsapporo Seiryou Hospital_General Clinical Department
    • Kanagawa
      • Yamato-shi, Kanagawa, Japan, 242-0004
        • Not yet recruiting
        • Tsuruma Kaneshiro Diabetes Clinic_Internal medicine
    • Kanagawa, Japan
      • Chigasaki-shi, Kanagawa, Japan, Japan, 253-0044
        • Recruiting
        • Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine
      • Kawasaki-shi, Kanagawa, Japan, Japan, 212 0024
        • Not yet recruiting
        • Matsuba Clinic_Internal Medicine
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Not yet recruiting
        • OCROM Clinic_Internal medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NNC0487-0111
Participants will receive NNC0487-0111 administered subcutaneously once weekly with one of four dose levels as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: 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 Comparator: NNC0487-0111 Placebo
Participants will receive placebo administered subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative change in body weight
Time Frame: From baseline (week 0) to week 84
Measured as percentage of body weight (%).
From baseline (week 0) to week 84

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured as centimetre (cm).
From baseline (week 0) to week 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2026

Primary Completion (Estimated)

February 5, 2029

Study Completion (Estimated)

February 5, 2029

Study Registration Dates

First Submitted

September 10, 2026

First Submitted That Met QC Criteria

September 10, 2026

First Posted (Actual)

September 16, 2026

Study Record Updates

Last Update Posted (Actual)

September 16, 2026

Last Update Submitted That Met QC Criteria

September 10, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9490-8088
  • U1111-1313-7707 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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