DelfaGLP-1 Atlas

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STOP KNEE-OA

RecruitingPhase 4

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

Effect of Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA): A Randomized, Double-Blind, Placebo-Controlled Trial

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

4

Recruiting sites

4

Enrollment

352

estimated

Study population

Obesity / overweight, Osteoarthritis

Key I/E criterion

—

Primary endpoint

•Percentage of patients who undergo knee replacement in the target joint

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06191848
Org study ID75430

Timeline

Milestones

Study first posted2024-01-05actual
Study start2024-11-19actual
Last update posted2025-04-30actual
Primary completion2027-05estimated (month precision)
Study completion2037-05estimated (month precision)

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightOsteoarthritis

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•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.

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 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 had within the past 6 months prior to randomisation any of the following: acute myocardial infarction, cerebrovascular accident, unstable angina, or hospitalisation due to congestive cardiac failure (are also exclusion criteria for elective knee replacement)
–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.

Endpoints (17)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes
10
Weight & body composition
4
Patient-reported / QoL
3

Weight & body composition

4 endpoints
Secondary/protocol endpoint

Percentage change in bodyweight

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

≥5% body weight reduction

Time frame:Baseline, Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

≥10% body weight reduction

Time frame:Baseline, Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

≥20% body weight reduction

Time frame:Baseline, Week 72

≥20% weight-loss responders

threshold achievement, improvement

Patient-reported / QoL

3 endpoints
Secondary/protocol endpoint

Physical Health

Time frame:Baseline, Week 72

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Mental Health

Time frame:Baseline, Week 72

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Physical Activity

Time frame:Baseline, Week 72

change from baseline, improvement

Other clinical outcomes

10 endpoints
Primary/protocol endpoint

Percentage of patients who undergo knee replacement in the target joint

Time frame:within 72 weeks of randomization

threshold achievement, event

Secondary/protocol endpoint

Osteoarthritis Pain

Time frame:Baseline, Week 72

WOMAC pain

change from baseline, improvement

Secondary/protocol endpoint

Osteoarthritis Function

Time frame:Baseline, Week 72

WOMAC function

change from baseline, improvement

Secondary/protocol endpoint

Osteoarthritis Stiffness

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Non-opioid prescription pain medication use

Time frame:Baseline, between 68-72 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Opioid prescription pain medication use

Time frame:Baseline, between 68-72 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Mean change in use of prescription opioid pain medication

Time frame:Baseline, between 68-72 weeks

change from baseline, improvement

Secondary/protocol endpoint

Participant willingness to undergo knee replacement surgery

Time frame:within the 72 weeks since randomization

composite event, event

componentsknee replacement surgery, reenter waiting list for knee replacement

Secondary/protocol endpoint

Long-term (5-year) progression to knee replacement

Time frame:within 260 weeks of randomization

time to event, event

Secondary/protocol endpoint

Long-term (10-year) progression to knee replacement

Time frame:within 520 weeks of randomization

threshold achievement, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.