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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

8 criteria

  • 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 trial?

15 criteria

  • 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
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Investigated drugs

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.

What is already known about the treatment

4P004 - An investigational medication administered through intra-articular injection directly into the knee joint, currently being studied in clinical trials for the treatment of knee synovitis and osteoarthritis. This experimental drug is being evaluated for its potential effectiveness in reducing osteoarthritis-related knee pain, with its primary assessment point set at week 4 of treatment. While the exact molecular mechanism is still under investigation as part of the clinical trial process, the medication is being tested in a controlled, double-blind study setting to determine both its efficacy and safety profile in patients with knee joint conditions.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518916-38-00Protocol code4MB-4P004-P-INFLAMEstimated enrolment129 patientsSponsor4moving Biotech

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