Study of intra-articular liraglutide (4P004) for patients with knee synovitis and osteoarthritis

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What is this study about?

This clinical trial investigates a new treatment for patients with knee synovitis and osteoarthritis, conditions that cause pain and inflammation in the knee joint. The study will test a medication called 4P-004, which contains the active substance liraglutide, given through intra-articular injection directly into the knee joint.

The purpose of this research is to determine how well 4P-004 works in reducing knee pain and whether it is safe to use. During the study, participants will receive either 4P-004 or placebo injections. The treatment period lasts 12 weeks, during which participants will have their knee pain and overall condition regularly evaluated.

The medication will be administered as an injection solution, with a maximum daily dose of 2 milligrams. Throughout the study, participants will undergo various assessments to monitor their response to treatment, including evaluations of pain levels during daily activities and overall knee function. The study includes regular check-ups to monitor the participants’ health and safety.

1 Initial evaluation

You will undergo a magnetic resonance imaging (MRI) scan to confirm knee synovitis

Your doctor will evaluate your ability to walk (either unaided or with a cane)

Your pain levels and osteoarthritis symptoms will be assessed

Basic health measurements will be taken, including blood pressure, pulse rate, weight, and height

2 Treatment administration

You will receive either 4P-004 or a placebo solution through an injection directly into your knee joint

The treatment assignment is random and neither you nor your doctor will know which treatment you receive

3 Follow-up visits

You will attend follow-up visits at weeks 2, 4, 6, 8, 10, and 12 after treatment

During each visit, your knee pain will be evaluated using standardized pain assessment tools

Your overall condition will be assessed through physical examination

Blood tests and urine samples will be collected to monitor your health

You will be asked to rate your pain during specific activities

4 Pain monitoring

You will need to track your daily knee pain levels

Pain will be measured using the WOMAC Pain score (a standardized pain assessment tool)

You will need to rate pain during activities that typically cause discomfort

5 Final assessment

A final evaluation will occur at week 12

This will include physical examination, pain assessment, and laboratory tests

Your overall response to treatment will be evaluated

Any side effects experienced during the study will be documented

Who Can Join the Study?

Must be aged between 40 and 80 years
Must weigh more than 40 kilograms
Must have a body mass index (BMI) between 18.5 and 35 (BMI is a measure calculated from your height and weight to determine if you are at a healthy weight)
Must be able to walk either independently or with a cane for support
Must have experienced knee pain from osteoarthritis for at least 6 months before study participation
Must have synovitis (inflammation of the joint lining) in the knee that will be treated, confirmed by MRI (magnetic resonance imaging – a medical scanning technique that creates detailed images of the inside of your body)
Both men and women can participate in the study
Must meet specific requirements regarding osteoarthritis diagnosis and pain levels

Who Cannot Join the Study?

History of previous knee surgery or joint replacement in the target knee
Presence of other types of arthritis (inflammation of joints) besides osteoarthritis
Recent corticosteroid injections (anti-inflammatory medications) in the target knee within the past 3 months
Active infection in the knee joint
Severe obesity with BMI (Body Mass Index) greater than 40
Autoimmune disorders (conditions where the immune system attacks healthy cells)
Current participation in other clinical trials
Pregnancy or breastfeeding
Severe heart, liver, or kidney disease
Uncontrolled diabetes (high blood sugar levels)
History of blood clotting disorders
Active cancer or cancer treatment within the past 5 years
Severe mental health conditions that could affect study participation
Use of blood-thinning medications
Known allergies to study medication components

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
CENTRUM MEDYCZNE REUMA PARK	Warsaw	Poland
Gyncentrum Sp. z o.o.	Katowice	Poland

Other Sites

Site Name	City	Country
Hospital Quironsalud Sagrado Corazon	Sevilla	Spain
Hospital Hm Rosaleda Hm La Esperanza	Santiago De Compostela	Spain
Sanos A/S	Gandrup	Denmark
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Pratia S.A.	Skorzewo	Poland
Centre Hospitalier Universitaire De Nice	Nice	France
Hopital Beaujon	Clichy	France
Clinica Vistahermosa Grupo Hla S.L.	Alicante	Spain
Mojqhrjgt Iqwosfxhgi Cndnzgxw Ssthnzhn Sbl z oqjv	Warsaw	Poland
Clgziz Hlkpzktbqwi Udknfjvbbkmgn Rizbf	Reims	France
Hanmvrpg Uoqayatkedmtn Mftjbzw Dv Vdnsufmmhe	Santander	Spain
Poij Tvkie Hqigqioa Ujhscnnguspu	Sabadell	Spain
Hmpmbn Hlwtxuee	Herlev	Denmark
Heygytxs Upwyjnzdbizkd dn A Cacbsk	A Coruna Galicia	Spain

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	15.09.2025
France	Recruiting	15.09.2025
Poland	Recruiting	15.09.2025
Spain	Recruiting	15.09.2025

Trial locations

Investigated drugs:

Liraglutide

4P004 is an experimental medication that is administered directly into the knee joint (intra-articular injection). It is being studied for treating knee synovitis (inflammation of the joint lining) and osteoarthritis. The medication aims to reduce pain in patients with knee osteoarthritis, with effects being evaluated particularly at 4 weeks after treatment.

Investigated diseases:

Knee Synovitis – A condition characterized by inflammation of the synovial membrane that lines the knee joint. The synovial tissue becomes swollen and produces excess fluid, leading to pain and stiffness in the knee. This condition can cause warmth around the joint, reduced range of motion, and joint tenderness.

Knee Osteoarthritis – A degenerative joint disease affecting the knee, where the cartilage that cushions the ends of bones gradually wears down over time. The condition causes the joint space to narrow and bone surfaces to change, leading to stiffness and reduced mobility. As it progresses, the knee may become swollen, and movement may produce a grating sensation. The condition typically develops slowly and can affect one or both knees.

Trial ID:

2024-518916-38-00

Protocol code:

4MB-4P004-P-INFLAM

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of intra-articular liraglutide (4P004) for patients with knee synovitis and osteoarthritis

What is this study about?

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Who Cannot Join the Study?