NCT06191848

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

Effect of Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA): A Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: University of Melbourne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

• Obesity
• Knee Osteoarthritis
• Osteoarthritis, Knee

Interventions

Type	Name	Description
DRUG	Tirzepatide	Participants will receive tirzepatide subcutaneously
DRUG	Placebo	Participants will receive placebo subcutaneously

Timeline

• Start date: 2024-11-19
• Primary completion: 2027-05-01
• Completion: 2037-05-01
• First posted: 2024-01-05
• Last updated: 2025-04-30

Locations

4 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study