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

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide.

This is a trial of tirzepatide in people with obesity and knee osteoarthritis.

Participants will be randomized to take a weekly injection of tirzepatide or a placebo for a total of 72 weeks.

It had two arms (groups): Tirzepatide (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 352 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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 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.

The full record lists 13 inclusion and 27 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-11-19 with completion listed for 2027-05.

It ran at 4 sites in Australia (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of patients who undergo knee replacement in the target joint (time frame: within 72 weeks of randomization).

It also tracked 16 secondary outcomes, for example Osteoarthritis Pain, Osteoarthritis Function, Osteoarthritis Stiffness, Percentage change in bodyweight, Physical Health and Mental Health.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide in 352 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.