Status and phase
Conditions
Treatments
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Female participants must:
Exclusion criteria
Participant will be ineligible for inclusion if they meet any of the following criteria:
Have been deemed eligible to enter the waiting list for knee replacement in the contralateral knee by an orthopaedic surgeon at one of the participating study sites.
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
Have laboratory evidence indicative of diabetes mellitus during screening.
Have personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
Have an active malignancy (excluding basal or squamous cell skin cancer).
Have had a transplanted organ or awaiting an organ transplant
Have received chronic systemic glucocorticoid therapy (for more than 14 days) in prior 3 months or have a significant, active autoimmune abnormality (e.g., lupus or rheumatoid arthritis) that the study doctor deems likely to require systemic glucocorticoid therapy during the next 18 months.
Have any other medical conditions, abnormal laboratory tests or concomitant medications that make them unsuitable for participation:
Have answered "yes" to questions 4 or 5 on the "Suicidal Ideation" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) during screening, OR
Have answered yes to any questions in the "Suicidal Behaviour" section of the C-SSRS during screening. AND
The behaviour or ideation occurred in the last month
Are study site personnel, or immediate family of a member of the study site.
Have been enrolled in any other study of an investigational product within the past ninety days or are currently enrolled in such a study.
Primary purpose
Allocation
Interventional model
Masking
352 participants in 2 patient groups, including a placebo group
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Central trial contact
Angela Cochrane; Michelle M Dowsey
Data sourced from clinicaltrials.gov
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