Phase 2 Osteoarthritis Trial, Recruiting

Written by an AI model from 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 who are able to read, understand, and sign a consent form agreeing to take part in the study
• People who are willing and able to follow the study's instructions and attend all required visits
• People who have been diagnosed with osteoarthritis (OA) of the knee, with symptoms that have been present for at least 3 months before the screening visit
• People whose knee OA has been confirmed by X-ray as a grade 2 or 3 severity (using a standard medical scoring method called the Kellgren-Lawrence scale)
• People aged 45 years or older, of any sex
• People with a Body Mass Index (BMI) of 30 or above (this means a weight range that doctors classify as obese)
• People who are otherwise in generally good health, as determined by the trial doctor based on medical history, physical check-up, heart trace (ECG), and blood tests
• People who have not had enough pain relief from standard treatments for knee OA — such as physiotherapy, paracetamol, anti-inflammatory medicines, steroid or hyaluronic acid injections — or who cannot tolerate those treatments, in the opinion of the trial doctor
• People with a knee pain score of 20 or more (on a 0–50 scale using a standard questionnaire called WOMAC) at both the screening and baseline visits
• People who are willing to stop taking most pain medications during the study and use only paracetamol (up to 4,000 mg per day) as the permitted rescue medication

Who may not be able to join:

• People who have had a partial or full knee replacement in either knee
• People who have had surgery or a knee scope (arthroscopy) on the target knee within the past year
• People whose knee OA was caused by an injury in the last 5 years
• People whose other (non-target) knee is more painful than the knee being studied, as measured at the baseline visit
• People who have major surgery planned in the next 6 months
• People with a thyroid condition that is not well controlled, in the opinion of the trial doctor
• People who have lost more than 5% of their body weight in the 6 months before the screening visit
• People who have had weight-loss (bariatric) surgery in the past 12 months
• People with another ongoing condition (other than OA) that affects their target knee, or a systemic illness known to significantly affect joints — such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, or reactive arthritis
• People with certain conditions affecting joint or bone health — such as bone fractures related to osteoporosis, bone tissue death (osteonecrosis), severe knee misalignment, or specific types of OA — in the opinion of the trial doctor
• People with another active condition (such as back pain radiating down the leg, bursitis, or tendon inflammation) that significantly affects pain in the target knee, in the opinion of the trial doctor
• People with a score of 15 or higher on a standard depression questionnaire (PHQ-9) at screening
• People with a history of gout or pseudogout where the trial doctor considers there to be a high chance of a flare-up during the study that would need anti-inflammatory treatment
• People with hip dislocation or a congenital hip condition combined with joint damage
• People who have previously taken part in a study involving a drug class called DACRA or amylin
• People with a significant neurological or psychiatric condition, in the opinion of the trial doctor
• People who have had a steroid injection into the target knee within the past 3 months (or within 6 months for long-acting steroid injections), a hyaluronic acid injection into the target knee within 6 months, or any steroid injection into another major joint within the past 30 days (or 3 months for long-acting types)
• People who have taken systemic (whole-body) corticosteroids for a musculoskeletal condition for more than 14 days in the past 6 months
• People who have started or changed any OA treatment (medical or non-medical) in the 4 weeks before joining the study, or who are likely to change treatment during the study
• People taking obesity medications, including GLP-1 medicines (such as semaglutide or liraglutide), unless the dose has been stable for at least 6 months before the screening visit
• People with low vitamin D levels (below 25 nmol/L) — though rescreening may be possible after vitamin D supplementation
• People with a known significant drug allergy or hypersensitivity
• People with a current or recent cancer diagnosis or cancer treatment within the past 5 years (some exceptions apply for certain minor, fully treated skin or cervical conditions — confirm with trial site)
• People with a history of alcohol or drug misuse within the past 5 years, in the opinion of the trial doctor
• People who have taken part in another clinical drug trial within the past 90 days
• Women who are pregnant or breastfeeding, or women of childbearing potential who are not willing to use a highly effective form of contraception from enrolment until at least 3 months after the study ends
• Men who are sexually active with a female partner who could become pregnant, who are not willing to ensure their partner uses highly effective contraception, or who are not willing to avoid donating sperm during the study and for at least 3 months after it ends
• People considered unsuitable for any other reason, in the opinion of the trial doctor

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