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

NCT07822061 | Recruiting Phase 3

• 2 other identifiers: NN9490-8088U1111-1313-7707
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 26

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Relative change in body weight

  Measured as percentage of body weight (%).

  From baseline (week 0) to week 84

Secondary Outcomes (1)

• Change in waist circumference measured according to Japan society for the Study of Obesity (JASSO) guideline

  From baseline (week 0) to week 84

Study Arms (2)

NNC0487-0111

EXPERIMENTAL

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 Placebo

PLACEBO COMPARATOR

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)

Interventions

NNC0487-0111 DRUG

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

NNC0487-0111

Placebo (matched to NNC0487-0111) DRUG

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.

NNC0487-0111 Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (sex at birth).
• Age 18 years or above at the time of signing the informed consent.
• 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.
• 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).

You may not qualify if:

• \- 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.
• HbA1c ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
• History of type 1 or type 2 diabetes mellitus.
• 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.
• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (26)

Shinsapporo Seiryou Hospital_General Clinical Department

Sapporo, Hokkaido, 004-0004, Japan

RECRUITING

Tsuruma Kaneshiro Diabetes Clinic_Internal medicine

Yamato-shi, Kanagawa, 242-0004, Japan

NOT YET RECRUITING

Hayashi Diabetes Clinic_Internal Medicine and Diabetes Medicine

Chigasaki-shi, Kanagawa, Japan, 253-0044, Japan

RECRUITING

Matsuba Clinic_Internal Medicine

Kawasaki-shi, Kanagawa, Japan, 212 0024, Japan

NOT YET RECRUITING

OCROM Clinic_Internal medicine

Suita-shi, Osaka, 565-0853, Japan

NOT YET RECRUITING

TOSAKI Clinic for Diabetes and Endocrinology_Diabetes and Endocrinology

Aichi, 468-0009, Japan

RECRUITING

The University of Tokyo Hospital, Diabetes and Metabolic

Bunkyo-ku, Tokyo, 113-8655, Japan

NOT YET RECRUITING

Tokuyama clinic_Diabetic internal medicine

Chiba, 261-0004, Japan

NOT YET RECRUITING

Akaicho Clinic_Internal medicine

Chiba-shi, Chiba, 260-0804, Japan

RECRUITING

Suidoubashi Medical Clinic_Internal Medicine

Chiyoda-ku, Tokyo, 101-0065, Japan

RECRUITING

Tokyo Asbo Clinic_Internal Medicine

Chuo-ku, Tokyo, 104-0031, Japan

RECRUITING

Kuroda Orthopedic Clinic_Orthopedic Surgery and Internal Medicine

Fukuoka-shi, Fukuoka, 814-0165, Japan

RECRUITING

Naka Kinen Clinic_Internal medicine

Ibaraki, 311-0113, Japan

RECRUITING

Iwamoto Internal Medicine Clinic_Diabetes Internal Medicine

Kagawa, 765-0071, Japan

RECRUITING

Takai Internal Medicine Clinic_Internal Medicine

Kamakura-shi, Kanagawa, 247 0056, Japan

RECRUITING

Motomachi Takatsuka Naika Clinic_Internal Medicine

Kanagawa, 231-0023, Japan

NOT YET RECRUITING

Yokohama Minoru Clinic_Internal medicine

Kanagawa, 232-0064, Japan

NOT YET RECRUITING

JCHO Kyushu Hospital_Department of Endocrinology and Metabolism

Kitakyushu-shi, Fukuoka, 806-8501, Japan

NOT YET RECRUITING

Seino Internal Medicine Clinic_Internal medicine

Koriyama-shi, Fukushima, 963-8851, Japan

RECRUITING

National Hospital Organization Kyoto Medical Center_Diabetic Center

Kyoto-shi, Kyoto, 612-8555, Japan

NOT YET RECRUITING

The University of Osaka Hospital_Metabolic Medicine

Osaka, 565-0871, Japan

RECRUITING

Morimoto Clinic_Pain Clinic

Osaka-shi, Osaka, 530-0041, Japan

NOT YET RECRUITING

Tokyo-Eki Center-building Clinic_Internal Medicine

Tokyo, 103-0027, Japan

NOT YET RECRUITING

Clinical Research Hospital Tokyo_Internal medicine

Tokyo, 160-0004, Japan

RECRUITING

ToCROM Clinic_Internal Medicine

Tokyo, 160-0008, Japan

RECRUITING

Yao Tokushukai General Hospital_Internal medicine

Yao City, Osaka, 581-0011, Japan

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 16, 2026
• Study Start: September 7, 2026
• Primary Completion (Estimated): February 5, 2029
• Study Completion (Estimated): February 5, 2029
• Last Updated: September 16, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

JP (26)