A Double-blind, Placebo-controlled, Randomized Study to Evaluate the Efficacy and Safety of KBP-336 as an Adjunct to Diet and Exercise in Obese Individuals with Osteoarthritis of the Knee
Osteoarthritis can cause painful, stiff joints, and carrying excess body weight puts extra pressure on the knees. This clinical trial looks at whether an experimental medicine called KBP-336 can help. Adults taking part will follow a diet and exercise programme while receiving either KBP-336 or a dummy treatment (placebo). Neither you nor the doctors will choose or know which one you receive. Over roughly six months (183 days), researchers will monitor your body weight, knee pain, stiffness, and everyday mobility. Participants will also have access to standard paracetamol pain relief tablets if needed. The aim is to find out whether KBP-336 is safe and whether it can effectively help people lose weight while reducing the joint pain caused by knee osteoarthritis.
At a glance
What is this study about?
Knee osteoarthritis is a common condition where the protective cartilage inside the knee joint wears down over time. This can lead to persistent pain, swelling, and stiffness, making ordinary activities like walking, standing, or climbing stairs difficult. Carrying excess body weight places extra physical strain on these joints and can increase inflammation throughout the body, often making symptoms worse.
Researchers are investigating whether a new medicine, KBP-336, can help tackle both weight and joint pain together. In this trial, the medicine is being tested as an 'add-on' to lifestyle changes, meaning all participants will be supported to follow a healthy diet and exercise routine. The study aims to see if KBP-336 helps people lose a meaningful amount of weight and whether that weight loss leads to noticeable relief from knee pain.
To ensure fair results, this is a randomised, double-blind, placebo-controlled study. Half the participants will receive KBP-336 and half will receive a matching dummy treatment (placebo). Neither the study team nor the participants will know who is taking which treatment until the trial ends. If people experience knee discomfort during the study, standard pain relief tablets (paracetamol) will be available as rescue medication.
By testing KBP-336, scientists hope to discover whether it can offer a safe, effective option for improving everyday movement and quality of life for people living with both obesity and joint pain.
Key takeaways
- Tests a new medicine (KBP-336) combined with diet and exercise for knee pain and weight loss.
- Compares the study drug against an inactive dummy treatment (placebo) over about six months.
- Open to adults aged 18 and over who have knee osteoarthritis and are living with obesity.
- Includes access to standard paracetamol tablets if you need rescue pain relief.
- Taking part is completely voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to men and women aged 18 and older who are living with obesity and have diagnosed osteoarthritis in the knee.
To take part, you must be willing to commit to regular clinic visits and follow a guided diet and physical activity plan for around six months. You will also need to be able to complete questionnaires about your pain and daily activities.
You may not be able to join if you have certain other significant medical conditions, unstable health problems, or if you are taking specific medications that could interfere with the study results or compromise your safety. The study team will assess your full medical history before you can take part.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or over.
- I have been diagnosed with osteoarthritis in my knee.
- I am living with obesity or carrying significant extra body weight.
- I am willing and able to follow a diet and exercise routine.
- I can attend regular clinic visits for roughly six months.
What does participation involve?
Taking part in this study lasts for around 6 months (183 days). You will be randomly assigned by a computer to receive either KBP-336 or an inactive placebo. You will also receive advice and support to follow a healthier diet and gentle exercise programme.
Throughout the study, you will attend regular check-ups at a hospital or clinical trial site. At these visits, doctors will measure your weight, waist-to-hip ratio, and overall health. You will have DXA scans (low-dose X-ray scans) to check your body fat and bone density. You will also fill out standard questionnaires about your knee pain, morning stiffness, and how easily you can carry out daily tasks.
If you have knee flare-ups, you will be provided with paracetamol tablets to take as 'rescue' pain relief, and you will track how often you need to use them.
Potential risks and benefits
Locations (4)
- —UnverifiedDenmark
- —UnverifiedCzechia
- —UnverifiedRomania
- —UnverifiedPoland
Common questions
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active ingredients. It helps researchers prove whether any health improvements are truly caused by the study drug rather than psychological factors or lifestyle changes alone.
Can I still take painkillers if my knee hurts?
Yes. Participants will be provided with standard paracetamol (Panodil 500 mg) to use as rescue pain relief if their knee pain becomes uncomfortable during the study.
What is a DXA scan and is it safe?
A DXA scan is a quick, painless scan that uses very low amounts of X-rays to measure your bone strength and body fat. It is a routine and safe hospital test.
Will I have to pay for the study medicine or tests?
No. All study medications, scans, tests, and doctor visits related to the trial are provided free of charge, and travel expenses are often reimbursed.
Can I leave the study early if I change my mind?
Yes. You are free to leave the trial at any time, for any reason, without giving an explanation and without your normal medical treatment being affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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