All studies
AuthorisedTherapeutic exploratory (Phase II)Interventional

Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) with Atorvastatin (ATORGO)

This research study is investigating if a widely used medicine, atorvastatin, can prevent or slow down the development of eye problems in people who have recently been told they have Graves' Disease. Graves' Disease is a condition where your immune system attacks your thyroid gland, making it overactive. Sometimes, this can also lead to eye problems, known as Graves' Ophthalmopathy. The study aims to see if taking atorvastatin for 12 months can reduce the number of people who develop active eye symptoms. Researchers will also be looking at how the medicine affects their quality of life, antibody levels, and if there are any genetic reasons some people respond better than others. It's a 'Phase II' study, which means it's an early-stage trial trying to understand if the treatment works and is safe.

At a glance

Status
Authorised
Phase
Therapeutic exploratory (Phase II)
Sponsor
Region Skane
Enrolment target
554
Start
04 Feb 2026

What is this study about?

This research is looking into a condition called Graves' Ophthalmopathy, often shortened to GO. This is an eye problem that can sometimes affect people who have Graves' Disease, a type of overactive thyroid.

Researchers want to find out if a commonly used medicine called atorvastatin can help prevent or reduce the severity of these eye problems. Atorvastatin is usually prescribed to lower cholesterol, but some studies suggest it might have other helpful effects, including reducing inflammation, which could be useful in GO. The main goal is to see how many people taking atorvastatin go on to develop active eye symptoms within a year, compared to those who don't take it (though the summary doesn't explicitly state a comparison group, this is standard for trials).

Beyond simply counting how many people get eye problems, the study will also look at how quickly GO might start, how severe it gets, and if people need other treatments like steroids for their eyes. They'll also check how participants' quality of life changes, measure certain markers in their blood, and even look at genetic information to understand why some people might respond better to the treatment than others. This helps scientists learn more about the condition and how to treat it better in the future.

Key takeaways

  • This study explores a common cholesterol drug (atorvastatin) for a new use.
  • It aims to prevent or reduce eye problems in people with Graves' Disease.
  • Participation involves taking a tablet and attending regular check-ups for about 18 months.
  • The study assesses eye health, quality of life, and genetic factors.
  • It's a Phase II trial, focusing on effectiveness and safety.

Who may be eligible?

This study is looking for adult volunteers, from 18 years old and up. Both men and women are welcome to take part.

To be eligible, you would need to have been recently diagnosed with Graves' Disease, which is an overactive thyroid condition. The study is specifically interested in people who don't yet have active eye problems related to Graves' Disease, or if they do, the symptoms aren't severe.

There will be other, more detailed criteria that the study team will discuss with you to make sure it's safe and appropriate for you to join. This might include checking your overall health and any other medications you're taking.

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.

  1. Are you 18 years old or older?
  2. Have you recently been diagnosed with Graves' Disease (an overactive thyroid)?
  3. Have you not yet developed severe eye problems related to Graves' Disease?
  4. Are you able to take daily medication as prescribed?
  5. Are you willing to attend regular appointments for about 18 months?
Answer every question to see your result.

What does participation involve?

If you join this study, you will likely be asked to take atorvastatin tablets daily. The dose mentioned is 40mg. You would have regular appointments at the clinic over about 18 months, which will involve check-ups to monitor your eye health, general well-being, and any side effects. These visits will probably include physical examinations, blood tests, and filling out questionnaires about your quality of life. The study team will track how your eye condition progresses, if at all, and evaluate the effect of the medication. The total time you'd be involved in the study, including follow-up, would be around 18 months.

Potential risks and benefits

Taking part in this study could potentially offer some benefits, such as receiving a medicine that might help prevent or reduce the severity of Graves' eye disease. You would also receive regular medical monitoring of your condition. However, there are also potential risks; atorvastatin, like all medications, can have side effects. These can range from mild, like muscle pain or stomach upset, to more serious, though rare, liver problems. The study team will explain all known risks. Remember, you have the right to withdraw from the study at any time and 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.
  • Unverified
    Sweden

Common questions

What is Graves' Ophthalmopathy?

It's an eye condition that can affect people with an overactive thyroid (Graves' Disease), causing symptoms like bulging eyes, irritation, or double vision.

What is atorvastatin?

Atorvastatin is a common medicine usually prescribed to lower high cholesterol, but this study is looking at its potential to help with eye problems in Graves' Disease.

How long will the study last?

If you take part, you would be involved in the study for about 18 months.

Will I know if I'm getting the treatment?

In many studies like this, participants are randomly assigned to a treatment or a comparison group, and sometimes neither you nor your doctor knows which group you're in until the study ends. The researchers will explain this fully.

What is a 'Phase II' study?

It's an early stage of clinical research that aims to find out if a new treatment is effective for a specific condition and to check its safety over a longer period in more people.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.