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Osteoarthritis (OA) of the KneeEarly Phase 1NPO-OOPS-TKRNCT06807970

Optimization of Obesity for Total Knee Replacement With Glucagon-like Peptide-1 Receptor Agonist

A Early Phase 1 study testing Glucagon-like peptide-1 receptor agonists (GLP 1 RA) in people with Osteoarthritis (OA) of the Knee, run by The University of Hong Kong at 1 site in Hong Kong.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Studies have shown that obese patients undergoing total knee replacement (TKR) surgery face a higher risk of perioperative issues such as increased use of pain medication, surgical site infections, and the need for revision surgeries compared to non-obese patients. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Osteoarthritis (OA) of the Knee
What is being tested?
Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
54 participants
Where
1 siteHong Kong
Study dates
1 Sep 2025to 1 Jul 2028
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age between 40 and 80 years old
  • BMI ≥27 kg/m2
  • On the surgical waiting list for primary TKR
  • Willing and able to cooperate in a weight management programme.
  • Meeting indication for semaglutide

Who cannot join

  • Revision surgery or surgery for neoplastic disease
  • A medical condition which in the opinion of the investigators makes the patient unsuitable for participation in the trial
  • Contraindication to GLP-1RA, like history of pancreatitis, severe gastrointestinal diseases such as gastroparesis, thyroid cancer, and inflammatory bowel disease
  • Lack of acceptance of the randomisation process.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Queen Mary Hospital

    Hong Kong, Pokfulam, 999077

Other trials in Hong Kong

About this study

Official title: Novel Perioperative Optimization of Obese Osteoarthritic Patients Pending Total Knee Replacement With Glucagon-like Peptide-1 Receptor Agonist (NPO-OOPS-TKR)

Studies have shown that obese patients undergoing total knee replacement (TKR) surgery face a higher risk of perioperative issues such as increased use of pain medication, surgical site infections, and the need for revision surgeries compared to non-obese patients. Obesity is also linked to more significant preoperative pain and lingering symptoms post-surgery. Consequently, there's a growing interest in weight loss interventions prior to TKR to enhance perioperative care and outcomes. Recent retrospective studies have indicated that such interventions can improve physical function post-TKR.

Research focusing on weight loss interventions before joint replacement surgery is limited.

Read more

There is currently a gap in research regarding RCTs on weight loss interventions using anti-obesity drugs before TKR, particularly in Asian populations.

One promising avenue under exploration involves the use of glucagon-like peptide 1 receptor agonists (GLP-1RAs) as anti-obesity medication before total knee replacement (TKR) surgery. However, there are currently no randomized controlled trials (RCTs) examining the effects of GLP-1RAs on knee arthroplasty outcomes. Large database studies have indicated that GLP-1RAs may decrease the likelihood of certain post-surgery complications but increase the risk of others.

In summary, addressing obesity through weight loss interventions, particularly with GLP-1RAs, holds promise for improving outcomes in TKR patients. However, further research, including randomized controlled trials, is necessary to fully understand the effects of GLP-1RAs on perioperative outcomes and patient health.

Read the detailed description

2.1 Hypothesis Hypothesis for this pilot trial is conducting trial of GLP-1RA for perioperative optimization for TKR feasible. The null hypothesis for the full trial is that clinical, functional and quality of life (QoL) outcomes in obese patients undergoing TKR will not be improved if this is preceded by GLP-1 RA induced weight loss.

  1. Study objective The primary aims of this pilot study are 1) estimate adherence, tolerability and follow-up rates, 2) recruitment and management challenges.

The secondary aims are to assess the effect of semaglutide for perioperative optimization in TKR and gather data to estimate the feasibility like tolerability and sample size for a future trial.

Being tested
Glucagon-like peptide-1 receptor agonists (GLP 1 RA), Control (Standard treatment)
Keywords
osteoarthritis
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Glucagon-like peptide-1 receptor agonists (GLP 1 RA)Drug

    Patients in intervention group will have GLP-1RA semaglutide for 48 weeks and then stops for one month before and after TKR following the latest anesthesia guideline for GLP-1RA. Followed by TKR They will continue semaglutide for 48 weeks during the post-operative follow-up period. This is decided based on balancing treatment effect of semaglutide, waiting time for TKR, and TKR follow-up requirement. In Hong Kong, waiting time for TKR would be ~4 years and so a period of 12 months treatment of semaglutide is reasonable. And in the STEP 6 trial, weight loss at week 52 (-12%) is similar to that in study end at week 68(-13·2%), and STEP5 trial showed maintaining semaglutide to week 104 could maintain weight loss of similar degree as in week 52. And the consensus of assessing TKR Patient-Reported Outcome Measures (PROMs) is one year follow up.

  • Control (Standard treatment)Other

    If patients are randomized to the control group, they will receive routine follow-up with general advice on diet and physical activity but will not receive semaglutide, and will not be offered a specific management program for their weight. This is in line with current practice.

Study groups in NCT06807970
Study groupRoleWhat they receive
GLP-1RAExperimentalIntervention group: GLP-1RA +TKR: Patients in intervention group will have GLP-1RA semaglutide for 48 weeks and then stops for one month before and after TKR following the latest anesthesia guideline for GLP-1RA. Followed by TKR They will continue semaglutide for 48 weeks during the post-operative follow-up period. This is decided based on balancing treatment effect of semaglutide, waiting time for TKR, and TKR follow-up requirement. In Hong Kong, waiting time for TKR would be ~4 years and so a period of 12 months treatment of semaglutide is reasonable. And in the STEP 6 trial, weight loss at week 52 (-12%) is similar to that in study end at week 68(-13·2%), and STEP5 trial showed maintaining semaglutide to week 104 could maintain weight loss of similar degree as in week 52. And the consensus of assessing TKR Patient-Reported Outcome Measures (PROMs) is one year follow up.
Receives: Drug: Glucagon-like peptide-1 receptor agonists (GLP 1 RA)
Control (standard treatment)Placebo comparatorControl Group: TKR alone: If patients are randomized to the control group, they will receive routine follow-up with general advice on diet and physical activity but will not receive semaglutide, and will not be offered a specific management program for their weight. This is in line with current practice.
Receives: Other: Control (Standard treatment)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual analogue scale and analgesic consumption

    Assess at enrolment, prior to and after TKR, and at each follow-up till 12 months. Pain is chosen as the primary outcome because up to 14 patients in weight loss groups (versus 2 patients in control groups) in previous studies chosen to decline/delay TKR due to pain relief, suggesting a prominent effect of weight optimization on pain relief.

    Pain is evaluated using two approaches. The first method is visual analog scale which involves the numeric rating scale, which ranges from 0 to 10, with 0 representing no pain and 10 representing the most intense pain. The second method involves monitoring analgesic consumption, with higher consumption indicating more severe pain.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

Secondary outcomes (9)

  1. A composite score of clinical situation

    A patient is likely to have a composite score reported in numerical scale if they experience the following conditions:

    (i) Failed same-day rehabilitation (within 24 hours) (ii) Have any peri-operative complications (medical or surgical) (iii) Have any post-operative complications (medical or surgical) leading to delayed discharge, such as fractures, neuropraxia, sepsis, nosocomial infections, myocardial infarction, bowel obstruction, venous thromboembolism, cardiovascular events, or renal failure (iv) Have any wound complications (breakdown, infections, hematomas, dehiscence) (v) Have joint infections as per Musculoskeletal Infection Society (MSIS) Criteria (vi) Have any unplanned procedures and/or readmissions within the first 12 months following total knee replacement (TKR) (vii) Death from any cause

    A higher composite score suggests that the patients are in a poorer condition.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

  2. Length of stay

    Patients' conditions worsen as the length of stay (unit in day) in acute and rehabilitation hospitals for total knee replacement (TKR), as well as any subsequent related admissions, increases.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

  3. Body weight

    Body weight (kg - kilogram) will be measured at each visit.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

  4. Radiological parameters

    Lower limb alignment will be measured in degree to assess changes before and after surgery.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

  5. height

    height (cm-centimètre)will be measured at each visit.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

  6. waist circumference

    waist circumference (cm - centimètre) will be measured at each visit.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

  7. blood pressure

    Both systolic and diastolic blood pressure (mmHg - Millimeter of mercury) will be measured at each visit.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

  8. Western Ontario and McMaster Universities Arthritis Index (WOMAC)

    Western Ontario and McMaster Universities Arthritis Index (WOMAC) consists of 24 items divided into 3 subscales Pain (5 items), Stiffness (2 items)Physical Function (17 items). The test questions are scored on a scale of 0-4, which correspond to: None (0), Mild (1), Moderate (2), Severe (3), and Extreme (4).

    The scores for each subscale are summed up, with a possible score range of 0-20 for Pain, 0-8 for Stiffness, and 0-68 for Physical Function. A sum of the scores for all three subscales gives a total WOMAC score.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

  9. The Knee Society Score

    The Knee Society Score is clinician-administered consisting of a Knee and Function Score. The Knee Score rates the knee joint itself and allocates a maximum of 100 points for the evaluation of range of motion (1 point per 5°, maximum 125°), stability (medial/lateral (15 points) and anterior/posterior (10 points)) and pain (50 points) with deductions for extension lag, flexion contracture and malalignment (if leg axis < 5 or > 10° on radiological examination) [1]. A maximum score of 100 points represents a well-aligned knee with 125° of motion, almost none anteroposterior or mediolateral instability and no pain. The Function Score considers walking distance (50 points) and stair climbing (50 points) with deduction for the use of a walking aid . A patient who can walk unlimited and has no trouble with climbing stairs will obtain the maximum Function Score of 100 points.

    Measured: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2025
  2. Study start1 Sep 2025
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06807970
Sponsor's protocol ID
UW24-423
Acronym
NPO-OOPS-TKR
Status last verified
Aug 2026
First submitted
15 Jan 2025
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: for further patient privacy protection

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Glucagon-like peptide-1 receptor agonists (GLP 1 RA) in people with Osteoarthritis (OA) of the Knee, run by The University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analogue scale and analgesic consumption (time frame: As part of the standard of care when undergoing TKR, patients are routinely assessed at enrolment, 1 month and same day before surgery, and at 6 weeks,3 months, 6 months and 12 months post-surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06807970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

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