A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoarthritis Lose Weight and Reduce Pain

Short name AMAZE 5

NCTNCT07481630Other idNN9490-8026Other idU1111-1313-6585Other id2024-520444-42

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Recruiting
Phase: Phase 3
Enrollment: 400 participants (estimated)
Sponsor: Novo Nordisk A/S · Industry
Design: Randomized · Quadruple masking
Countries: 10 countries
United States, Australia, Bulgaria, Canada, Denmark, Greece, Italy, Poland, Spain, Turkey (Türkiye)
Start: 13 Apr 2026
Primary completion: 14 Aug 2028 (estimated)
Completion: 14 Aug 2028 (estimated)
First posted: 19 Mar 2026
Last update posted: 9 Jul 2026
Conditions: Obesity · Knee Osteoarthritis (OA)

Timeline

1 trial · 1 ongoing

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2026202720282029

Ph 3
AMAZE 5
NCT07481630
13 Apr 2026 to est. 14 Aug 2028

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 who have excess body weight and knee osteoarthritis. There are 2 study treatments in this study taken as injections under the skin once a week. Participants will either get NNC0487-0111 (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participants get is decided by chance.

Interventions

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

Arms3

Experimental
NNC0487-0111 dose level 1
Participants will be randomized to receive NNC0487-0111 dose level 1 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Experimental
NNC0487-0111 dose level 2
Participants will be randomized to receive NNC0487-0111 dose level 2 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Placebo comparator
Placebo
Participants will receive placebo matched to NNC0487-0111 subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.

Primary outcomes2

Outcomes the sponsor listed as primary.

Relative change in body weight
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as percentage (%) of body weight.
Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as score on a scale. Western Ontario and McMaster Universities Arthritis Index (WOMAC) measures symptoms in the areas of pain, stiffness, and physical function. The measure consists of 24 items yielding 3 subscale scores and 1 total score. WOMAC raw scores are transformed to a standardised 0 to 100 score range. Higher scores indicate worse pain, stiffness, physical function, and overall osteoarthritis- related disability.

Secondary outcomes(20)

Change in WOMAC physical function score
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as score on a scale. Physical function score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse physical function.
Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQOL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation (SD) of 10. Higher scores indicate better functional health and well-being. The physical functioning ranges from 19.0 to 57.6.
Change in body weight
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as kilogram (kg).
Change in body mass index (BMI)
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as kilograms per meter squared (kg/m\^2).
Change in WOMAC stiffness score
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as score on a scale. Stiffness score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Score ranges from 0-100 and higher scores indicate worse stiffness.
Change in WOMAC total score
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as score on a scale. Total score will be calculated according to the guidelines provided in the WOMAC User Guide XI. Total score ranges from 0-100 and higher scores indicate worse overall osteoarthritis- related disability.
Change in waist circumference
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as centimetre (cm).
Change in systolic blood pressure (SBP)
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as millimetre of mercury (mmHg).
Change in diastolic blood pressure (DBP)
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as mmHg.
Change in total cholesterol
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as ratio to baseline.
Change in high-density lipoprotein (HDL) cholesterol
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as ratio to baseline.
Change in low-density lipoprotein (LDL) cholesterol
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as ratio to baseline.
Change in very low-density lipoprotein (VLDL) cholesterol
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as ratio to baseline.
Change in non-HDL cholesterol
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as ratio to baseline.
Change in triglycerides
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as ratio to baseline.
Change in high-sensitivity C-reactive protein (hsCRP)
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as ratio to baseline.
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as percentage (%) of HbA1c.
Change in fasting plasma glucose (FPG)
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as millimole per liter (mmol/L).
Number of participants allowed using rescue analgesics during washout period (Yes/no)
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as number of participants
Amount of allowed rescue analgesics used during washout period
Time frame · From baseline (week 0) to (week 80)
Registry description
Measured as dose of analgesics.

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

Key inclusion Criteria: * Male or female (sex at birth). * Age 18 years or above at the time of signing the informed consent. * Clinical diagnosis of knee osteoarthritis (American College of Rheumatology criteria) with radiographic changes (Kellgren Lawrence (KL) grades 2 to 3 as per central reading) in 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 more than (\>) 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 involving WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) questionnaire (acetaminophen 4 gram (g)/day is allowed as rescue medication up until 24 hours before those visits). Exclusion Criteria: * Glycated haemoglobin more than or equal to (≥) 6.5% \[(48 millimoles per mole (mmol/mol)\] as measured by the central laboratory at screening. * History of type 1 or type 2 diabetes mellitus as declared by the participant or reported in the medical records. * 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. * Any joint prosthesis or joint replacement in target knee. * Arthroscopy or injections into target knee within the last 90 days prior to screening. * Any other joint disease in target knee including gout and pseudogout.

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