Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)
NCT ID: NCT06191848
Last Updated: 2025-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
352 participants
INTERVENTIONAL
2024-11-19
2037-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Tirzepatide
Participants will receive tirzepatide subcutaneously
Placebo
Drug: Placebo Dose: once-weekly Duration: 72 weeks Mode: subcutaneous
Placebo
Participants will receive placebo subcutaneously
Interventions
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Tirzepatide
Participants will receive tirzepatide subcutaneously
Placebo
Participants will receive placebo subcutaneously
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion 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 a clinically significant gastric emptying abnormality.
* Have had a history of acute or chronic pancreatitis.
* Have obesity induced by other endocrinologic disorders
* Have an unstable psychiatric disorder
* Have a Patient Health Questionnaire (PHQ-9) score of \>15 during screening
* Have been deemed by the study doctor to be actively suicidal,
* 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
* Have uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and/or diastolic blood pressure above or equal to 100 mmHg)
* Have severe renal impairment defined as an eGFR \<30 mL/min/1.73 m2 at screening visit.
* Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 mIU/L at screening visit
* Have acute or chronic hepatitis or abnormal liver function tests as measured by either alanine aminotransferase or alkaline phosphatase \>200 IU.
* Have any other known contraindication to any glucagon-like peptide-1 receptor agonists.
* 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
University of Melbourne
OTHER
Responsible Party
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Principal Investigators
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Michelle M Dowsey
Role: PRINCIPAL_INVESTIGATOR
University of Melbourne
Locations
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St Vincents Hospital Melbourne
Fitzroy, Victoria, Australia
Western Health
Melbourne, Victoria, Australia
Austin Health-Repatriation Hospital
Melbourne, Victoria, Australia
Eastern Health
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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75430
Identifier Type: -
Identifier Source: org_study_id
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