Authorised Therapeutic exploratory (Phase II) Graves Ofthalmopathy

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

EU CTIS ID: 2023-504654-35-00

What this study is testing

The primary objective of this trial is to determine if atorvastatin can prevent the development of active GO in patients newly diagnosed with GD.

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Age 18–85 years
  • Diagnosis of Graves' Disease (GD):TSH < 0.1 μU/L. Elevated free T4 (fT4) and/or free T3 (fT3). Positive TSH receptor antibodies (TRAb).
  • Sufficient knowledge of Swedish to understand medical information and participate in telephone or video calls.

You likely can't join if

  • Pregnancy, planned pregnancy within 12 months or lactation
  • Concurrent use of medications that interact with statins, particularly CYP3A4 inhibitors or inducers.
  • Need of corticosteroid protection for planned radioiodine therapy
  • Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial
  • Prior treatment with statins, selenium, corticosteroids, or other immunosuppressive medications for more than 7 days within the 3 months preceding GD diagnosis.
  • Existing Graves' Ophthalmopathy (GO) at the time of GD diagnosis.
See the full eligibility criteria
Who can join
  • Age 18–85 years
  • Diagnosis of Graves' Disease (GD):TSH < 0.1 μU/L. Elevated free T4 (fT4) and/or free T3 (fT3). Positive TSH receptor antibodies (TRAb).
  • Sufficient knowledge of Swedish to understand medical information and participate in telephone or video calls.
What rules you out
  • Pregnancy, planned pregnancy within 12 months or lactation
  • Concurrent use of medications that interact with statins, particularly CYP3A4 inhibitors or inducers.
  • Need of corticosteroid protection for planned radioiodine therapy
  • Mental inability, reluctance or language difficulties that result in difficulty understanding the meaning of participation in the trial
  • Prior treatment with statins, selenium, corticosteroids, or other immunosuppressive medications for more than 7 days within the 3 months preceding GD diagnosis.
  • Existing Graves' Ophthalmopathy (GO) at the time of GD diagnosis.
  • Known hypersensitivity to atorvastatin or other statins.
  • Active liver disease.
  • Alcohol abuse.
  • Elevated liver enzymes (ASAT/ALAT > 3 times the upper normal limit in two consecutive tests).

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.