A Study Testing How Well LTG-001 Works and Its Safety in Patients with Knee Osteoarthritis

What is this study about?

This study is looking at osteoarthritis of the knee, which is a condition where the cartilage in the knee joint wears down over time, causing pain, stiffness, and difficulty moving. The treatment being tested is called LTG-001, which comes as a coated tablet that is taken by mouth. This medication will be compared to placebo to see which works better. The purpose of the study is to find out if LTG-001 is effective at reducing pain in people who have osteoarthritis of the knee and to check if it is safe to use.

The study is designed as a crossover trial, which means that participants will receive both the active medication and placebo at different times during the study. Each person will go through two treatment periods that last two weeks each. Before starting the treatment periods, there will be a run-in phase where participants keep a diary of their pain levels for seven days. During one treatment period, participants will take LTG-001 tablets, and during the other period, they will take placebo tablets. There will be a break of two weeks between the two treatment periods to make sure the effects of the first treatment have worn off before starting the second one. Throughout the study, participants will not be allowed to take other pain medications for osteoarthritis except for a rescue medication that is permitted by the study.

During the study, participants will be asked to rate their pain levels using different scales and questionnaires. These include questions about pain, stiffness, and how well they can perform daily activities. Participants will also be asked to complete a physical performance test and give their overall opinion about how the treatment is working. The study will monitor safety by checking for any unwanted effects, measuring vital signs like blood pressure and heart rate, doing blood tests, and taking blood samples to measure the levels of LTG-001 in the body. The study is expected to start enrolling participants in October 2025 and finish by August 2026.

1 Diary run-in phase

Before starting treatment, a diary run-in phase takes place lasting 7 days.

During this phase, daily pain scores must be recorded in a study diary on at least 6 out of 7 days.

The pain will be assessed using a scale from 0 to 10, where 0 means no pain and 10 means the worst possible pain.

This phase serves to establish baseline pain levels before treatment begins.

2 First treatment period

The first treatment period begins on Day 1 and lasts for 14 days (until Day 14).

At the start of this period (Day 1), an assessment will be performed before taking the first dose of medication.

During this period, either LTG-001 tablet or a placebo (an inactive substance that looks like the real medication) will be taken. The assignment to one of these options is random, and neither the treating physician nor the patient will know which medication is being received.

The medication is a coated tablet for oral use.

Throughout this period, daily pain scores must continue to be recorded in the study diary.

Pain will be assessed using two scales: the average daily pain and the worst daily pain, both measured on a scale from 0 to 10.

The WOMAC questionnaire will be completed at the end of this period (Day 14). This questionnaire assesses pain, stiffness, and physical function related to knee osteoarthritis.

A physical function test called StEPP will also be performed, which evaluates pain during physical activity.

At the end of this period (Day 14), an assessment of overall improvement will be completed using the Patient Global Assessment (PGA), which rates the response to treatment as excellent, very good, good, fair, or poor.

The use of any rescue medication (pain relief medication allowed by the study protocol) for the target knee will be recorded throughout this period.

Only medications permitted by the study protocol may be taken during this period. All other medications for osteoarthritis, including opioids, NSAIDs (non-steroidal anti-inflammatory drugs), COX-2 inhibitors, topical medications, and duloxetine, must be discontinued.

3 Washout period

After the first treatment period ends, a washout period begins on Day 15 and lasts until Day 27 (13 days).

During this period, no study medication will be taken.

This period allows the body to eliminate the previous medication before starting the next treatment period.

4 Second treatment period

The second treatment period begins on Day 28 and lasts for 14 days (until Day 41).

At the start of this period (Day 28), an assessment will be performed before taking the first dose of medication.

During this period, the medication that was not received in the first period will be taken. If LTG-001 tablet was taken in the first period, placebo will be taken in this period, and vice versa.

The medication is a coated tablet for oral use.

Throughout this period, daily pain scores must continue to be recorded in the study diary.

Pain will be assessed using two scales: the average daily pain and the worst daily pain, both measured on a scale from 0 to 10.

The WOMAC questionnaire will be completed at the end of this period (Day 41). This questionnaire assesses pain, stiffness, and physical function related to knee osteoarthritis.

A physical function test called StEPP will also be performed, which evaluates pain during physical activity.

At the end of this period (Day 41), an assessment of overall improvement will be completed using the Patient Global Assessment (PGA), which rates the response to treatment as excellent, very good, good, fair, or poor.

The use of any rescue medication (pain relief medication allowed by the study protocol) for the target knee will be recorded throughout this period.

Only medications permitted by the study protocol may be taken during this period. All other medications for osteoarthritis must remain discontinued.

5 Safety monitoring throughout the study

Throughout the entire study, any side effects or adverse events will be monitored and recorded.

Vital signs (such as blood pressure and heart rate), electrocardiogram (ECG) (a test that measures the electrical activity of the heart), and laboratory tests (blood and urine tests) will be performed at scheduled visits.

During the active treatment period (when LTG-001 tablet is taken), blood samples will be collected after the first and last dose to measure the concentration of LTG-001 and its breakdown products in the blood.

Any changes in health status should be reported during study visits.

6 End of study visit

After completing both treatment periods, a final visit called the End of Study (EOS) visit will take place.

At this visit, final assessments and tests will be performed to evaluate overall health and any lasting effects of the treatments.

After this visit, participation in the study will be complete.

Who Can Join the Study?

You must be between 40 and 80 years old at the time you sign the consent form
You must sign a consent form that shows you understand and agree to follow all study requirements and restrictions
You must be willing and able to attend all scheduled visits, follow the treatment plan, complete laboratory tests, keep a study diary, and communicate with the study staff
You must be willing to stop taking any medications for osteoarthritis, which is a condition where the protective tissue in your joints wears down. This includes pain medications such as opioids (strong pain relievers), NSAIDs (common pain and inflammation reducers like ibuprofen), COX-2 inhibitors (a type of anti-inflammatory medication), creams or gels applied to the skin, and duloxetine (a medication for pain and mood) until the study is finished
You must agree to take only the medications that are allowed by the study from the beginning of the diary phase until the end of the study
You must have a confirmed diagnosis of osteoarthritis of the knee, which means you need to have X-rays of both knees taken during the screening period, meet specific medical diagnostic criteria, and show evidence of osteoarthritis with a KL grade of 2 or 3, which is a measurement of how severe the arthritis is based on X-ray findings
You must have had knee pain on most days for at least 3 months before starting the screening phase
Your pain level in the affected knee must be 4.0 or higher on a scale from 0 to 10 at two separate screening visits
Your pain scores on a questionnaire called WOMAC, which measures pain, stiffness, and function in your knee, must be 4.0 or higher on a scale from 0 to 10 at both the screening visit and on the first day of treatment
During a diary phase before treatment starts, you must record your average daily pain on at least 6 out of 7 days, your average pain score during this week must be between 5.0 and 9.0, and your pain levels should not vary too much from day to day
Your BMI, which is a measure of body weight in relation to height, must be 38 or less at the screening visit
If you are a woman who can become pregnant, you must be willing and able to use appropriate birth control methods during the study
If you are a man who is sexually active with a partner who can become pregnant, you must be willing and able to use appropriate birth control methods during the study

Who Cannot Join the Study?

You have rheumatoid arthritis, which is a different type of joint disease where the body’s defense system attacks the joints, or any other inflammatory arthritis, which means joint swelling caused by the body’s immune system
You have had a joint replacement surgery in the knee that is being studied, meaning an artificial knee has been placed in that knee
You have had surgery on the knee that is being studied within the past 6 months
You are planning to have surgery on the knee during the time of the study
You have received corticosteroid injections, which are anti-inflammation shots, in the knee being studied within the past 3 months
You have received hyaluronic acid injections, which are gel-like shots to cushion the knee joint, in the knee being studied within the past 6 months
You have a known allergy or bad reaction to any ingredient in the study medicine
You have serious liver disease, meaning your liver is not working properly
You have serious kidney disease, meaning your kidneys are not working properly
You have uncontrolled high blood pressure, meaning your blood pressure is too high and not managed with treatment
You have had a heart attack or stroke, which is when blood flow to the heart or brain is blocked, within the past year
You have cancer that is currently active or has been treated within the past 5 years, except for certain skin cancers
You are pregnant or breastfeeding, which means feeding a baby with milk from your breast
You are a woman who can become pregnant and are not using reliable birth control methods
You have a history of drug or alcohol abuse within the past 2 years
You are currently taking certain pain medicines that cannot be stopped during the study
You have any other serious medical condition that the doctor believes would make it unsafe for you to join the study

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Sanos A/S	Gandrup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	01.10.2025

Trial locations

Investigated drugs:

LTG-001

LTG-001 is an investigational medication being tested to treat pain in patients with osteoarthritis of the knee. This is an experimental treatment that is being studied to see if it can help reduce the pain that people experience when they have knee osteoarthritis, which is a condition where the cartilage in the knee joint breaks down over time.

Osteoarthritis of the knee – Osteoarthritis of the knee is a degenerative joint condition that affects the knee joint. It occurs when the protective cartilage that cushions the ends of the bones gradually wears down over time. As the cartilage deteriorates, the bones may begin to rub against each other, causing pain and stiffness. The condition typically develops slowly and worsens progressively over months or years. People with knee osteoarthritis often experience pain during movement, reduced flexibility, and difficulty performing daily activities such as walking or climbing stairs. The joint may also become swollen and feel stiff, especially after periods of inactivity or in the morning.

Trial ID:

2025-522755-26-01

Protocol code:

LTG-001-015

Trial Phase:

Therapeutic exploratory (Phase II)

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A Study Testing How Well LTG-001 Works and Its Safety in Patients with Knee Osteoarthritis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?