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Active (not recruiting) Phase 3 2024-520444-42-00

Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and knee osteoarthritis (AMAZE 5)

Phase 3 – large-scale trial before approval
Conditions: Overweight or obesity and knee osteoarthritis

Sponsor: Novo Nordisk A/S

trial.available_in: БГ
Overview
Trial status: Authorised CCI, CCI, Change in WOMAC physical function score, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score, Change in body weight, Change in body mass index (BMI), Change in WOMAC stiffness score, Change in WOMAC total score, CCI, Change in waist circumference, Change in systolic blood pressure (SBP), Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol and Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Use of allowed rescue analgesics during washout period (Yes/no), Amount of allowed rescue analgesics used during washout period, Use of pain medication (Yes/No), Amount of pain medication used, Change in pain medication (decrease/no change/increase), Change in knee pain intensity (NRS), Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation Relative change in body weight, Change in WOMAC Osteoarthritis Index NRS 3.1 (24-hour) (WOMAC) pain score
Description
CCI, CCI, Change in WOMAC physical function score, Change in SF-36v2® Health Survey Acute (SF-36v2 Acute) physical functioning score, Change in body weight, Change in body mass index (BMI), Change in WOMAC stiffness score, Change in WOMAC total score, CCI, Change in waist circumference, Change in systolic blood pressure (SBP), Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol and Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Use of allowed rescue analgesics during washout period (Yes/no), Amount of allowed rescue analgesics used during washout period, Use of pain medication (Yes/No), Amount of pain medication used, Change in pain medication (decrease/no change/increase), Change in knee pain intensity (NRS), Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation
Who can participate
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 220 participants
Interventions
NNC0487-0111 B 10142
Drug
NNC0487-0111 B 10141
Drug
Placebo
Drug
NNC0487-0111 B 10145
Drug
NNC0487-0111 B 10146
Drug
NNC0487-0111 B 10143
Drug
NNC0487-0111 B 10144
Drug
Locations 6
Bulgaria (1)
Denmark (1)
Greece (1)
Italy (1)
Poland (1)
Spain (1)
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
07.04.2026
Registry ID
2024-520444-42-00
Source
euclinicaltrials.eu
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