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NOT YET RECRUITING
NCT07883356
PHASE2

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

Sponsor: Region Skane

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

554

Start Date

2026-11-01

Completion Date

2033-05-01

Last Updated

2026-10-20

Healthy Volunteers

No

Interventions

DRUG

Atorvastatin

Atorvastatin 40 mg is administered orally once daily for 12 months, in addition to standard treatment for Graves' disease.

Locations (7)

Sahlgrenska University Hospital

Gothenburg, Sweden

Skåne University Hospital - Lund

Lund, Sweden

Skåne University Hospital - Malmö

Malmö, Sweden

Örebro University Hospital

Örebro, Sweden

Karolinska University Hospital

Stockholm, Sweden

Norrland University Hospital

Umeå, Sweden

Uppsala University Hospital

Uppsala, Sweden