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Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)

ConditionsObesityKnee OsteoarthritisOsteoarthritis, Knee
Trial statusActive, not recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Melbourne

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a body mass index of ≥ to 30 kg/m2.

Report one or more previous unsuccessful attempt to lose body weight via lifestyle modification.

Have been deemed eligible to enter the waiting list for primary knee replacement for the treatment of osteoarthritis in the target joint by an orthopaedic surgeon at one of the participating study sites.

Have moderate-to-severe knee osteoarthritis in the target joint, defined as a Kellgren-Lawrence grade two or greater.

Disqualifiers

Have been deemed eligible to enter the waiting list for knee replacement in the contralateral knee by an orthopaedic surgeon at one of the participating study sites.

Have used any prescription medications intended to promote weight loss (e.g., tirzepatide, liraglutide, semaglutide) in the three months prior to screening.

Have previously undergone any surgical or endoscopic procedure intended to promote weight loss.

Have been diagnosed with type 1 diabetes mellitus (T1DM) or T2DM

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tirzepatide

    Drug

    Participants will receive tirzepatide subcutaneously

  • Placebo

    Drug

    Participants will receive placebo subcutaneously

Treatment groups

352 Participants
are divided into 2 treatment groups
Group A: TirzepatideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage 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

Secondary outcomes

1

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
2

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
3

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
4

Percentage change in bodyweight

Mean percentage change in body weight at 72 weeks after randomization

Time frame
Baseline, Week 72

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Melbourne

Lead sponsor

Eli Lilly and Company

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: