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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • NNC0487-0111

    Drug

    NNC0487-0111 dose level 1 and dose level 2 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 )

    Drug

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

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: NNC0487-0111 dose level 1Experimental treatment 1 intervention
Group B: NNC0487-0111 dose level 2Experimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Relative change in body weight

Measured as percentage (%) of body weight.

Time frame
From baseline (week 0) to (week 80)
2

Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score

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.

Time frame
From baseline (week 0) to (week 80)

Secondary outcomes

1

Change in WOMAC physical function score

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.

Time frame
From baseline (week 0) to (week 80)
2

Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score

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.

Time frame
From baseline (week 0) to (week 80)
3

Change in body weight

Measured as kilogram (kg).

Time frame
From baseline (week 0) to (week 80)
4

Change in body mass index (BMI)

Measured as kilograms per meter squared (kg/m\^2).

Time frame
From baseline (week 0) to (week 80)

Other outcomes

Sponsors and contacts

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