Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)
Trial statusRecruiting
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
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
Treatments tested in this trial
- Tirzepatide
- Placebo
Treatment groups
352 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Melbourne
Lead sponsor
Eli Lilly and Company
Collaborator
Source ClinicalTrials.gov