NCT07883356|Not Yet RecruitingPhase 2DMC
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
ATORGO
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Sponsor study identifier
Secondary identifiers
CTIS
NIH
interventional
554
1 country
7
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 16, 2026
Actual (reported)October 20, 2026
Actual (reported)November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
November 1, 2032
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
May 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Development of Active Graves' Orbitopathy
Proportion of participants who develop active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3, as assessed by standardized ophthalmological evaluation.
12 months after randomization
Development of Active Graves' Orbitopathy at 3, 6, 9, 15, and 18 Months
3, 6, 9, 15, and 18 months after randomization
Genetic Factors Associated With Response to Atorvastatin
Baseline (genotyping) and 12 months (CAS)
Participants receive standard treatment for Graves' disease according to current clinical practice, without study treatment with atorvastatin. Standard care may include antithyroid drugs and other clinically indicated treatment.
Participants receive atorvastatin 40 mg orally once daily for 12 months in addition to standard treatment for Graves' disease. Standard treatment for Graves' disease is provided according to current clinical practice and may include antithyroid drugs and other clinically indicated treatment.
Atorvastatin 40 mg is administered orally once daily for 12 months, in addition to standard treatment for Graves' disease.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Formulated product
Atorvastatin Viatris 40 mg Filmtabletten
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
FILM-COATED TABLET
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Atorvastatin Viatris 40 mg Filmtabletten
Named ingredient: Atorvastatin
View registry recordSahlgrenska University Hospital
Gothenburg, Sweden
Skåne University Hospital - Lund
Lund, Sweden
Skåne University Hospital - Malmö
Tereza Planck
Region Skåne, Endokrinologimottagning
First Submitted
September 16, 2026
First Posted
October 20, 2026
Study Start
November 1, 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
November 1, 2032
Prophylactic Treatment With Atorvastatin for Chronic Migraine (ChronicStatinMig)
Time to Development of Active Graves' Orbitopathy
From diagnosis through 18 months
Correlations between circulating biomarker levels and Graves' ophthalmopathy clinical activity score
Baseline, 3 months, 12 months, and 18 months
Maximum Clinical Activity Score During Follow-up
From randomization through 18 months
Contact the study team to confirm eligibility.
Malmö, Sweden
Örebro University Hospital
Örebro, Sweden
Karolinska University Hospital
Stockholm, Sweden
Norrland University Hospital
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
May 1, 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 20, 2026
Record last verified: 2026-09
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