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Trial · Interventional

RecruitingPhase 3Registry data

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

Short name AMAZE 10

NCTNCT07822061 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8088Other idU1111-1313-7707

Overview

Status
Recruiting
Phase
Phase 3
Enrollment
400 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
1 country

Japan

Start
7 Sept 2026
Primary completion
5 Feb 2029 (estimated)
Completion
5 Feb 2029 (estimated)
First posted
16 Sept 2026
Last update posted
16 Sept 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20262027202820292030
  1. Ph 3

    AMAZE 10

    NCT07822061

    7 Sept 2026 to est. 5 Feb 2029

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • NNC0487-0111Drug
  • Placebo (matched to NNC0487-0111)Drug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative change in body weight

    Time frame · From baseline (week 0) to week 84

    Registry description

    Measured as percentage of body weight (%).

Secondary outcomes(1)
  1. 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

    Registry description

    Measured as centimetre (cm).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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