This is a trial of tirzepatide in people with obesity and knee osteoarthritis. The main purpose of this study is to see if tirzepatide can reduce number of these participants who require a knee replacement. Participants will be randomized to take a weekly injection of tirzepatide or a placebo for a total of 72 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
352
Participants will receive tirzepatide subcutaneously
Participants will receive placebo subcutaneously
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
RECRUITINGWestern Health
Melbourne, Victoria, Australia
RECRUITINGAustin Health-Repatriation Hospital
Melbourne, Victoria, Australia
RECRUITINGPercentage of patients who undergo knee replacement in the target joint
Percentage of patients who undergo knee replacement in the target joint
Time frame: within 72 weeks of randomization
Osteoarthritis Pain
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score. The WOMAC Pain subscale has 5-items, with a possible score range of 0-20, with higher scores indicating worse pain.
Time frame: Baseline, Week 72
Osteoarthritis Function
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Function Subscale Score. The WOMAC Function subscale has 17-items, with a possible range of 0-68, with higher scores indicating worse functional impairment.
Time frame: Baseline, Week 72
Osteoarthritis Stiffness
Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Stiffness Subscale Score. The WOMAC Stiffness subscale has 2-items, with a possible range of 0-8, with higher score indicating worse stiffness.
Time frame: Baseline, Week 72
Percentage change in bodyweight
Mean percentage change in body weight at 72 weeks after randomization
Time frame: Baseline, Week 72
≥5% body weight reduction
Percentage of participants with ≥5% body weight reduction at 72 weeks after randomization
Time frame: Baseline, Week 72
≥10% body weight reduction
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Eastern Health
Melbourne, Victoria, Australia
RECRUITINGPercentage of participants with ≥10% body weight reduction at 72 weeks after randomization
Time frame: Baseline, Week 72
≥20% body weight reduction
Percentage of participants with ≥20% body weight reduction at 72 weeks after randomization
Time frame: Baseline, Week 72
Physical Health
Mean change in the 36-item Short Form (SF-36) Physical Component Summary at 72 weeks after randomization. The SF-36 Physical Component Summary, a lower score indicates poorer physical health.
Time frame: Baseline, Week 72
Mental Health
Mean change in the 36-item Short Form Survey (SF-36) Mental Component Summary at 72 weeks after randomization. For the SF-36 Mental Component Summary, a lower score indicates poorer mental health.
Time frame: Baseline, Week 72
Physical Activity
Mean change in Physical Activity Scale for the Elderly (PASE) score at 72 weeks after randomization. The PASE has 12-items with a total score range from 0-400 or more, with higher scores indicating greater physical activity.
Time frame: Baseline, Week 72
Non-opioid prescription pain medication use
Proportion of participants reporting use of non-opioid prescription analgesics between 68-72 weeks after randomization
Time frame: Baseline, between 68-72 weeks
Opioid prescription pain medication use
Proportion of participants reporting use of prescription opioid analgesics between 68-72 weeks after randomization
Time frame: Baseline, between 68-72 weeks
Mean change in use of prescription opioid pain medication
Mean change in prescription opioids dose at 72 weeks after randomization
Time frame: Baseline, between 68-72 weeks
Participant willingness to undergo knee replacement surgery
Proportion of patients who undergo knee replacement in the target joint within 72 weeks of randomization or re-enter the waiting list within 72 weeks of randomization.
Time frame: within the 72 weeks since randomization
Long-term (5-year) progression to knee replacement
Percentage of patients who undergo knee replacement in the target joint within 5-years
Time frame: within 260 weeks of randomization
Long-term (10-year) progression to knee replacement
Percentage of patients who undergo knee replacement in the target joint within 10-years
Time frame: within 520 weeks of randomization