Actively Recruiting
Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)
Led by University of Melbourne · Updated on 2025-04-30
352
Participants Needed
4
Research Sites
649 weeks
Total Duration
On this page
Sponsors
U
University of Melbourne
Lead Sponsor
E
Eli Lilly and Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a body mass index of 30 kg/m2 or higher.
- Have tried and failed to lose weight through lifestyle changes.
- Be eligible to join the waiting list for primary knee replacement for osteoarthritis in the target joint as determined by an orthopedic surgeon.
- Have moderate-to-severe knee osteoarthritis in the target joint, with Kellgren-Lawrence grade two or higher.
- Be willing and able to learn self-injection and follow study procedures for the trial duration.
- Provide informed consent according to the study site's human research ethics requirements.
- Female participants must not be pregnant or breastfeeding.
- Female participants must not have reproductive potential, defined as surgical sterilization, congenital anomaly causing infertility, or post-menopausal status as specified (including hormone replacement therapy after menopause).
You will not qualify if you...
- Eligible to join the waiting list for knee replacement in the opposite knee.
- Used prescription weight loss medications like tirzepatide, liraglutide, or semaglutide in the past 3 months.
- Had any surgical or endoscopic weight loss procedures.
- Diagnosed with type 1 or type 2 diabetes.
- Laboratory evidence of diabetes during screening.
- Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
- Have an active cancer (except basal or squamous cell skin cancer).
- Had an organ transplant or awaiting one.
- Received chronic systemic glucocorticoid therapy (>14 days) in the prior 3 months or have autoimmune conditions likely needing glucocorticoid therapy in next 18 months.
- Have significant gastric emptying problems, history of pancreatitis, obesity caused by other endocrine disorders, unstable psychiatric disorders, or high depression scores (PHQ-9 >15).
- Active suicidal thoughts or behaviors recently as per screening scales.
- Uncontrolled high blood pressure (systolic ≥160 mmHg or diastolic ≥100 mmHg).
- Recent serious heart or brain events in the past 6 months.
- Severe kidney problems (eGFR <30 mL/min/1.73 m2).
- Abnormal thyroid-stimulating hormone levels outside 0.4 to 6.0 mIU/L.
- Liver diseases or abnormal liver function tests.
- Any contraindications to glucagon-like peptide-1 receptor agonists.
- Are study site staff or immediate family.
- Enrolled in another investigational product study within the past 90 days or currently enrolled.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
2
Western Health
Melbourne, Victoria, Australia, 3011
Actively Recruiting
3
Austin Health-Repatriation Hospital
Melbourne, Victoria, Australia, 3084
Actively Recruiting
4
Eastern Health
Melbourne, Victoria, Australia, 3128
Actively Recruiting
Research Team
A
Angela Cochrane
CONTACT
M
Michelle M Dowsey
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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