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

Sponsor
University of Melbourne
Study ID
NCT06191848
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Participants will receive tirzepatide subcutaneously
  • Placebo — DRUG
    Participants will receive placebo subcutaneously

Study Details

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.

Key Dates

Start date
Nov 19, 2024
Status verified
Dec 2024
Primary completion
May 31, 2027
Completion
May 31, 2037

Study Design

Enrollment
352 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tirzepatide
    Drug: Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1receptor (GLP1R) agonist Dose: Tirzepatide will be initiated at 2.5mg once weekly, with the dose increasing by a further 2.5mg every four weeks until the target weekly dose of 15mg is achieved (or participants reach a lower maximum tolerated dose of 5mg or 10mg). Duration: 72-weeks Mode: subcutaneous
  • Placebo Comparator: Placebo
    Drug: Placebo Dose: once-weekly Duration: 72 weeks Mode: subcutaneous

Primary Outcome Measure

Percentage of patients who undergo knee replacement in the target joint [ Time Frame: within 72 weeks of randomization ]

Central Contacts

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