Phase 4 Osteoarthritis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People with a body mass index (BMI) of 30 or higher (a measure of body weight relative to height that indicates obesity).
• People who have tried and not succeeded in losing weight through lifestyle changes (such as diet and exercise) at least once before.
• People who an orthopaedic surgeon at one of the study hospitals has placed, or agreed to place, on the waiting list for a first-time knee replacement surgery due to osteoarthritis in the affected knee.
• People with moderate-to-severe knee osteoarthritis in the affected knee, confirmed by X-ray scoring (Kellgren-Lawrence grade 2 or higher).
• People who are willing and able to learn how to give themselves injections of the study drug and follow the study procedures for the full length of the trial.
• People who have given their informed consent to participate in the study, in line with ethics committee requirements.

For female participants, additional criteria apply — women must:

• Not be currently pregnant or breastfeeding.
• Either be unable to become pregnant (due to surgical sterilisation or a condition present from birth), OR meet the criteria for menopause, which includes one of the following:
  • A woman over 40 years old whose periods stopped naturally for at least 12 consecutive months (without medications causing this), with a specific hormone level confirmed by a blood test (FSH ≥40 mIU/mL), and a negative pregnancy test before joining the study.
  • A woman over 55 years old whose periods stopped naturally for at least 12 consecutive months (without medications causing this).
  • A woman over 55 years old who started hormone replacement therapy (HRT) after a documented diagnosis of menopause.

Who may not be able to join:

• People who an orthopaedic surgeon has also placed, or agreed to place, on the waiting list for a knee replacement in the other knee (the one not being studied).
• People who have used prescription weight-loss medications (such as tirzepatide, liraglutide, or semaglutide) in the three months before their screening visit.
• People who have previously had surgery or a medical procedure specifically intended to help with weight loss (such as gastric bypass or gastric sleeve surgery).
• People who have been diagnosed with type 1 or type 2 diabetes, or whose screening blood tests show signs consistent with diabetes.
• People with a personal or family history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related hormone gland condition (Multiple Endocrine Neoplasia syndrome type 2).
• People who currently have an active cancer, with the exception of certain common skin cancers (basal or squamous cell skin cancer).
• People who have received an organ transplant or are currently waiting for one.
• People who have taken long-term steroid medications (for more than 14 days) in the past 3 months, or who have a significant autoimmune condition (such as lupus or rheumatoid arthritis) that the study doctor believes is likely to require long-term steroid treatment in the next 18 months.
• People who have a significant problem with how their stomach empties food (confirm with trial site).
• People who have a history of inflammation of the pancreas (pancreatitis), whether short-term or long-term.
• People whose obesity is caused by another hormone-related medical condition.
• People with an unstable mental health condition.
• People whose depression screening score (PHQ-9) is above 15 at the screening visit.
• People the study doctor considers to be actively at risk of suicide, or who gave specific answers at screening indicating recent serious thoughts of suicide or suicidal behaviour within the past month (as measured by a standardised assessment tool called the C-SSRS).
• People with uncontrolled high blood pressure (systolic blood pressure of 160 mmHg or above, and/or diastolic blood pressure of 100 mmHg or above).
• People who, in the six months before joining the study, have had a heart attack, stroke, unstable chest pain (unstable angina), or been hospitalised for heart failure.
• People with severely reduced kidney function (identified by a specific blood test result, eGFR below 30 mL/min/1.73m²) at the screening visit.
• People with thyroid hormone levels (TSH) outside the normal range of 0.4 to 6.0 mIU/L at the screening visit.
• People with active or long-term liver inflammation (hepatitis), or abnormal liver function blood test results above a specified level.
• People who have any other known medical reason that would make it unsafe to take a type of medication known as a GLP-1 receptor agonist (the class of drug being studied).
• People who work at the study site, or whose immediate family member does.
• People who have participated in another clinical trial of an experimental treatment in the past 90 days, or who are currently in such a trial.

Important: Always verify eligibility with the trial site directly before applying.