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
Location: See all (4) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Australia
St Vincents Hospital Melbourne
RECRUITING
Fitzroy
Austin Health-Repatriation Hospital
RECRUITING
Melbourne
Eastern Health
RECRUITING
Melbourne
Western Health
RECRUITING
Melbourne
Contact Information
Primary
Angela Cochrane
angela.cochrane@svha.org.au
+61392312364
Backup
Michelle M Dowsey
mmdowsey@unimelb.edu.au
+61392313955
Time Frame
Start Date: 2024-11-19
Estimated Completion Date: 2037-05
Participants
Target number of participants: 352
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Eli Lilly and Company
Leads: University of Melbourne

This content was sourced from clinicaltrials.gov

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