AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase 2, Randomized, Double-blind, Placebo-controlled Crossover Study Evaluating the Efficacy and Safety of LTG-001 in Patients with Osteoarthritis of the Knee

This study is looking at a new tablet called LTG-001 for people with knee osteoarthritis, a common condition causing pain and stiffness in the knee joints. The main goal is to find out if LTG-001 can help reduce knee pain and if it's safe to use. Participants will take either the new tablet or a 'dummy' tablet (placebo) for a period, then switch to the other one. This helps us compare how well LTG-001 works against no active treatment in the same person. We'll be carefully measuring pain levels, how well people can move, and any side effects to understand its effectiveness and safety.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Latigo Biotherapeutics Inc.

Enrolment target

180

Start

10 Nov 2025

Osteoarthritis of the knee

What is this study about?

This research study is about finding better ways to manage pain from knee osteoarthritis. Osteoarthritis is a very common condition where the cartilage in your joints wears down, leading to pain, stiffness, and sometimes swelling. It can make everyday activities like walking or climbing stairs difficult.

We are testing a new tablet, called LTG-001, to see if it can help reduce this pain and improve your ability to move. The study is designed very carefully: some people will receive the new tablet first, while others will get a 'dummy' tablet, known as a placebo. A placebo looks exactly like the real tablet but contains no active medicine. After a set period, participants will switch, so if you started with the active tablet, you'd then get the placebo, and vice versa. This is called a 'crossover' study, and it's a good way to compare the effects of the new tablet against no active treatment in the same person.

Throughout the study, we will be regularly checking your pain levels, how stiff your knee feels, and how well you can move. We'll also keep a close eye on your general health to make sure the tablet is safe and to spot any side effects. This is a 'Phase 2' study, which means we are still in the earlier stages of drug development, focusing on understanding if the treatment works and what the right dose might be, before larger studies are done.

Key takeaways

The study is testing a new tablet (LTG-001) for knee osteoarthritis pain.
It's a 'crossover' study, so you'll receive both the new tablet and a 'dummy' tablet at different times.
We will be carefully monitoring your pain, stiffness, movement, and general health.
The main aim is to see if LTG-001 helps reduce pain and if it's safe to use.
Participation involves regular clinic visits and health checks.

Who may be eligible?

To join this study, you must be at least 18 years old. We are including both men and women in the research.

There will be other specific health requirements that your study doctor will discuss with you. These are in place to make sure the study is safe for you and that the results we get are clear and accurate. For example, people with certain other health conditions or those taking particular medications might not be able to take part.

If you're interested, the first step is to talk to the study team. They will go through a full list of criteria to check if this study is right for you.

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.

Are you at least 18 years old?
Do you have knee osteoarthritis?
Are you able to attend regular clinic appointments?
Are you willing to potentially take either the study tablet or a placebo?
Are you comfortable with regular health checks like blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will involve several visits to the clinic over a period of weeks. You will be given either the new study tablet (LTG-001) or a dummy tablet, and you won't know which one you are taking at any given time. After a set period, you'll switch to the other tablet.

During the study, you'll be asked to complete questionnaires about your pain and how your knee feels. You might also need to keep a pain diary at home. We will regularly check your vital signs (like blood pressure), take blood samples, and perform an ECG (a simple heart test) to monitor your health. You'll also have a physical examination of your knee.

We will carefully track any medications you take and ask if you experience any side effects. The total time you'll be involved in the study will be some weeks, including a follow-up period after you stop taking the study medication.

Potential risks and benefits

Taking part in this study could offer some benefits, such as receiving a potential new treatment for your knee pain and having your condition closely monitored by medical professionals. Your participation also helps researchers learn more about knee osteoarthritis and contribute to developing new medicines for others. However, there's no guarantee you will personally benefit. As with any medicine, there is a possibility of side effects from the study tablet, which could range from mild to more serious. You will be closely monitored for any reactions. You also might experience no benefit from the tablet at all. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is osteoarthritis of the knee?

It's a condition where the protective cartilage in your knee joint gradually wears away, causing pain, stiffness, and sometimes swelling.

What is a 'dummy' tablet (placebo)?

A placebo is a pill that looks just like the study medicine but doesn't contain any active ingredients. It helps us see if the new medicine works better than no treatment.

Will I know if I'm getting the real tablet or not?

No, this is a 'blinded' study, meaning neither you nor the study doctors will know which tablet you are getting at any time. This helps ensure fair results.

How long will I be in the study?

The study involves a few weeks of taking the medication and having check-ups, plus an initial assessment period and a follow-up.

Can I stop participating if I want to?

Yes, you are free to withdraw from the study at any point, for any reason, without it affecting your future medical care.