Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
Key facts
- Where
- Gothenburg, Lund, Malmö, Örebro, Stockholm, Umeå, and Uppsala, SwedenSee the 7 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07883356, who can take part
Where in Sweden
- Sahlgrenska University HospitalGothenburg, SwedenContact: Helena Filipsson Nyström, MD, PhDNo longer taking part
- Skåne University Hospital LundLund, SwedenContact: Erik UddmanNo longer taking part
- Skane University Hospital MalmöMalmö, SwedenContact: Tereza Planck, MD, PhDNo longer taking part
- Örebro University HospitalÖrebro, SwedenContact: Jeanette Wahlberg Hughes, MD, PhDNo longer taking part
- Karolinska University HospitalStockholm, SwedenContact: Ileana Botusan, MD, PhDNo longer taking part
- Norrland University HospitalUmeå, SwedenContact: Marcus Imamovic, MDNo longer taking part
- Uppsala University HospitalUppsala, SwedenContact: Selwan KhamisiNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Region Skane
- Trial code
- NCT07883356EU 2023-504654-35-00
- Record updated
- 20 October 2026
- Original description
Graves' disease is an autoimmune condition that causes an overactive thyroid. Some people with Graves' disease develop thyroid eye disease, also called Graves' orbitopathy, which can cause swelling around the eyes, eye discomfort, double vision, changes in appearance, and, in severe cases, problems with vision.Read full original descriptionShow less
Graves' disease is an autoimmune condition that causes an overactive thyroid. Some people with Graves' disease develop thyroid eye disease, also called Graves' orbitopathy, which can cause swelling around the eyes, eye discomfort, double vision, changes in appearance, and, in severe cases, problems with vision.
The purpose of this study is to find out whether atorvastatin, a commonly used cholesterol-lowering medicine, can reduce the risk of developing active thyroid eye disease in adults who have recently been diagnosed with Graves' disease.
A total of 554 participants will be randomly assigned to one of two groups. One group will receive atorvastatin 40 mg once daily for 12 months in addition to standard treatment for Graves' disease. The other group will receive standard treatment for Graves' disease alone. Participants will be followed for 18 months.
During the study, participants will have regular assessments of their thyroid disease and their eyes. Blood samples and questionnaires about symptoms and quality of life will also be collected. The researchers will compare the two groups to determine whether atorvastatin reduces the development of active thyroid eye disease.
Inclusion: Age 18-85 years; Newly diagnosed Graves' disease, defined as TSH <0.1 with elevated free T4 and/or free T3 and positive TSH-receptor antibodies (TRAb); Ability to understand medical information in Swedish.
Exclusion: Prior treatment with statins, other lipid-lowering drugs, selenium, corticosteroids, or other immunosuppressive medications for more than 7 days within the 3 months preceding Graves' disease diagnosis; Concurrent use of medications that interact with statins, particularly CYP3A4 inhibitors or inducers; Need for corticosteroid prophylaxis in connection with planned radioiodine therapy; Existing Graves' ophthalmopathy at the time of Graves' disease diagnosis; Known hypersensitivity to atorvastatin or other statins; Active liver disease; Elevated liver enzymes (AST/ALT >3 times the upper limit of normal) in two consecutive tests; Pregnancy, planned pregnancy within 12 months, or lactation; Mental inability, reluctance, or language difficulties resulting in difficulty understanding the meaning of participation in the trial; Alcohol abuse; Creatine kinase (CK) >5 times the upper limit of normal at screening/baseline.