Effect of Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA): A Randomized, Double-Blind, Placebo-Controlled 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.
• 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.
• Be willing to and capable of learning how to self-inject the study drug and follow study procedures for the duration of the trial.
• Provide informed consent to study participation in line with the requirements of the human research ethics committee of the study site.
⁃ Female participants must:
• Not be currently pregnant or breastfeeding AND
• Not be of reproductive potential, defined as:
• Infertile due to surgical sterilization or congenital anomaly, OR
• Post-menopausal defined as:
• A woman over the age of 40 years with spontaneous cessation of menses for at least 12 consecutive months (in the absence of medications known to induce amenorrhea), with a follicle-stimulating hormone ≥40mIU/mL, and a negative pregnancy test prior to study entry, OR
• A woman over the age of 55 years with cessation of menses for at least 12 consecutive months (in the absence of medications known to induce amenorrhea), OR
• A woman over the age of 55 years that has commenced hormone replacement therapy after a documented diagnosis of menopause.