Study on the Effects of KBP-336 and Paracetamol for Obese Patients with Knee Osteoarthritis

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What is this study about?

This clinical trial is focused on studying the effects of a new treatment called KBP-336 for individuals who are both obese and have osteoarthritis of the knee. Osteoarthritis is a condition that causes pain and stiffness in the joints, and it is common in the knees. Obesity can worsen the symptoms of osteoarthritis, making it more challenging to manage. The treatment being tested, KBP-336, is given as an injection and is being evaluated to see if it can help reduce body weight and knee pain when used alongside diet and exercise.

The purpose of this study is to assess how effective and safe KBP-336 is compared to a placebo. Participants in the study will receive either the new treatment or a placebo, and their progress will be monitored over a period of time. The study will look at changes in body weight and knee pain to determine the treatment’s effectiveness. Participants will be asked to follow a specific diet and exercise plan during the study.

Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. The study aims to provide valuable information on whether KBP-336 can be a helpful addition to diet and exercise for managing weight and knee pain in people with obesity and osteoarthritis of the knee. The results of this study could lead to new treatment options for individuals facing these health challenges.

1 joining the study

Upon joining the study, participants will be required to provide written informed consent, confirming their understanding of the study material and willingness to comply with study requirements.

2 baseline assessment

Participants will undergo a baseline assessment, which includes a physical examination, vital signs check, and laboratory tests to ensure good health. This assessment will also confirm the diagnosis of knee osteoarthritis and obesity.

3 medication withdrawal

Participants must withdraw from any current pain medications, except for the allowed rescue medication, which is a maximum of 4000 mg of paracetamol per day.

4 randomization and treatment

Participants will be randomly assigned to receive either the study medication KBP-336 or a placebo. KBP-336 is administered as a solution for injection under the skin (subcutaneous).

The frequency and dosage of KBP-336 will be determined by the study protocol and communicated to participants during the trial.

5 diet and exercise program

Participants will follow a diet and exercise program designed to support weight loss and improve knee function. This program is an essential part of the study.

6 regular follow-up visits

Participants will attend regular follow-up visits to monitor their health, body weight, and knee pain. These visits will include assessments using the WOMAC pain scale, which measures pain, stiffness, and physical function in the knee.

7 end of treatment assessment

At the end of the treatment period, which is approximately 183 days, participants will undergo a final assessment. This will include measurements of body weight, knee pain, and overall health.

8 study completion

Upon completion of the study, participants will receive information about the study results and any further steps if necessary.

Who Can Join the Study?

The participant must be able to read and understand the study materials and provide written consent to participate.
The participant must be willing to stop using any pain medication, such as Opioids (strong painkillers), Non-Steroidal Anti-Inflammatories (NSAIDs) (like ibuprofen, except for low-dose aspirin for blood clot prevention), COX-2 inhibitors (a type of pain reliever), Topical medication (creams or gels applied to the skin), and Serotonin and Noradrenaline Reuptake Inhibitors (SNRIs) (a type of antidepressant like Duloxetine). They can only use the allowed rescue medication, which is a maximum of 4000 mg of paracetamol per day.
The participant must be willing and able to follow the study requirements and instructions.
The participant must have a diagnosis of Osteoarthritis (OA) in the knee, confirmed by specific criteria, with symptoms present for at least 3 months before the study starts.
The participant must have a specific grade (2 or 3) of knee OA, determined by an X-ray taken during screening or a recent X-ray that meets the study’s requirements.
The participant must be at least 45 years old, regardless of gender.
The participant must have a Body Mass Index (BMI) of 30 kg/m² or higher. BMI is a measure of body fat based on height and weight.
The participant must be in good health, meaning no significant medical issues or abnormal findings during a physical exam, vital signs check, heart test (ECG), and lab results, as judged by the study doctor.
The participant must have experienced intolerance or insufficient pain relief with standard treatments for knee OA, such as physiotherapy, paracetamol, NSAIDs, short-term opioid use, or injections of hyaluronic acid or corticosteroids, as judged by the study doctor.
The participant must have a specific level of pain in the knee, measured by a WOMAC pain subscale score of 20 or higher on a scale of 0 to 50, both at the start of the study and during screening.

Who Cannot Join the Study?

Patients who do not have knee osteoarthritis or obesity cannot participate.
Patients who are not within the specified age range cannot participate.
Patients who are part of a vulnerable population cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
NZOZ LECZNICA MAK-MED s.c.	Nadarzyn	Poland

Other Sites

Site Name	City	Country
Pratia Prague s.r.o.	Prague	Czechia
Sanos A/S	Gandrup	Denmark
Pratia Brno s.r.o.	Brno-Stred	Czechia
L.K.N. Arthrocentrum s.r.o.	Hlucin	Czechia
Policlinica CCBR S.R.L.	Bucharest	Romania
Dc-Med Michal Kowalski sp.k.	Swidnica	Poland
Medical Plus s.r.o.	Uherske Hradiste	Czechia
Affidea Praha s.r.o.	Prague	Czechia
Pratia Pardubice a.s.	Pardubice	Czechia
Centrum Leczenia MIGRE	Wroclaw	Poland
Niepubliczny Zakład Opieki Zdrowotnej BifMed.	Bytom	Poland
Medyczne Centrum Hetmańska	Poznan	Poland
Qifstbq Mivxtym Coxipj Secbgh	Bucharest	Romania

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.12.2024
Denmark	Not recruiting	01.12.2024
Poland	Not recruiting	01.12.2024
Romania	Not recruiting	01.12.2024

Trial locations

Investigated drugs:

KBP-336 is a medication being tested to see if it can help people who are overweight and have knee pain due to osteoarthritis. The study is looking at how well this medication works when combined with a healthy diet and regular exercise. The goal is to find out if KBP-336 can help reduce body weight and relieve knee pain in people with this condition. The medication is being compared to a placebo, which is a substance with no active ingredients, to see if it has a real effect on weight loss and pain relief.

Knee Osteoarthritis – Knee osteoarthritis is a degenerative joint disease characterized by the breakdown of cartilage in the knee joint. As the cartilage wears away, bones begin to rub against each other, causing pain, swelling, and reduced motion in the joint. Over time, the joint may become stiffer and more painful, especially after periods of inactivity or excessive use. The condition can lead to the formation of bone spurs and a decrease in the joint space. It often progresses slowly, with symptoms worsening over years. Factors such as age, weight, and previous joint injuries can influence its progression.

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this excess energy is stored as fat, resulting in increased body weight. Obesity can lead to changes in body composition, including increased fat mass and altered distribution of fat in the body. It is often associated with metabolic changes and can affect various bodily systems. The progression of obesity can be influenced by genetic, environmental, and lifestyle factors.

Trial ID:

2024-517264-27-00

Protocol code:

KBP-336-CD-003

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of KBP-336 and Paracetamol for Obese Patients with Knee Osteoarthritis

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