Graves DiseasePhase 2ATORGONCT07883356
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
A Phase 2 study testing Atorvastatin in people with Graves Disease and Graves Disease (Basedow's Disease), run by Region Skane at 7 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Graves Disease, Graves Disease (Basedow's Disease), Graves Orbitopathy
- What is being tested?
- Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 7 sitesSweden
- Study dates
- 1 Nov 2026to 1 May 2033
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 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.
- Existing Graves' ophthalmopathy at the time of Graves' disease diagnosis.
- Known hypersensitivity to atorvastatin or other statins.
- Active liver disease.
Show all 11Show fewer
- Alcohol abuse.
- Elevated liver enzymes (AST/ALT >3 times the upper limit of normal) in two consecutive tests.
- Creatine kinase (CK) >5 times the upper limit of normal at screening/baseline.
- Concurrent use of medications that interact with statins, particularly CYP3A4 inhibitors or inducers.
- Need for corticosteroid prophylaxis in connection with planned radioiodine therapy.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Sweden7 sites
Sahlgrenska University Hospital
Gothenburg
Helena Filipsson Nyström, MD, PhD, +46-031-342 99 79, helena.filipsson@medic.gu.se
Skåne University Hospital - Lund
Lund
Erik Uddman, +46-46-17 12 31, erik.uddman@skane.se
erik.uddman@skane.se
Skåne University Hospital - Malmö
Malmö
Tereza Planck, MD, PhD, +46-40-337276, tereza.planck@med.lu.se
Örebro University Hospital
Örebro
Jeanette Wahlberg Hughes, MD, PhD, +46-019-602 12 92, jeanette.wahlberg-hughes@regionorebrolan.se
jeanette.wahlberg-hughes@regionorebrolan.se
Karolinska University Hospital
Stockholm
Ileana Botusan, MD, PhD, +46-08-123 721 14, ileana.botusan@regionstockholm.se
ileana.botusan@regionstockholm.se
Norrland University Hospital
Umeå
Marcus Imamovic, MD, +46-090-785 91 44, marcus.imamovic@umu.se
marcus.imamovic@umu.se
Uppsala University Hospital
Uppsala
Selwan Khamisi, +46-018-611 43 87, selwan.khamisi@akademiska.se
selwan.khamisi@akademiska.se
About this study
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.
Read more
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.
Read the detailed description
Graves' disease (GD) is an autoimmune thyroid disorder in which stimulating antibodies against the thyrotropin receptor cause hyperthyroidism. Graves' orbitopathy (GO), also referred to as thyroid eye disease, is the most important extrathyroidal manifestation of GD. GO may cause pain, swelling, redness, proptosis, diplopia, impaired quality of life, and, in severe cases, visual impairment. Although treatment of established GO has improved, there are currently limited options for preventing the development of GO in patients with newly diagnosed GD.
Observational studies have suggested that treatment with statins may be associated with a lower risk of developing GO in patients with GD. Statins have anti-inflammatory and immunomodulatory effects in addition to their lipid-lowering properties, providing a biological rationale for evaluating whether statin treatment can prevent GO. However, the preventive effect of statins has not been established in a sufficiently large randomized controlled trial.
ATORGO is a multicenter, randomized, controlled clinical trial designed to evaluate whether treatment with atorvastatin reduces the risk of developing active GO in adults with newly diagnosed GD. Participants are randomized in a 1:1 ratio to receive atorvastatin 40 mg once daily for 12 months in addition to standard treatment for GD, or standard treatment for GD alone.
Participants are followed for 18 months after randomization. Clinical assessments are performed at predefined study visits and include evaluation of thyroid disease and signs and symptoms of GO. Eye assessments include standardized documentation of clinical findings and photographs. To reduce the risk of assessment bias, relevant ophthalmic outcomes are evaluated by assessors who are blinded to treatment allocation using standardized photographic documentation where applicable.
Blood samples are collected during follow-up to assess thyroid function, thyrotropin receptor antibodies, and other study-related biomarkers. Patient-reported outcomes are assessed using validated questionnaires addressing thyroid-related and GO-related symptoms and quality of life.
The main objective is to determine whether adding atorvastatin to standard GD treatment reduces the development of active GO compared with standard GD treatment alone. Additional analyses will evaluate the timing and severity of GO, the need for GO-specific treatment, changes in thyroid autoimmunity, patient-reported outcomes, and potential biological markers associated with the development of GO or response to treatment.
The study is intended to provide evidence on whether a widely available, inexpensive, and well-established medication can be repurposed to prevent GO in patients with newly diagnosed GD.
- Conditions
- Graves Disease, Graves Disease (Basedow's Disease), Graves Orbitopathy, Graves Ophthalmopathy, Graves' Orbitopathy, Graves' Disease
- Being tested
- Atorvastatin
- Keywords
- Graves' disease, Graves' orbitopathy, Thyroid eye disease, thyroid-associated ophthalmopathy, thyroid-assoaciated orbitopathy, Atorvastatin, statin, Prevention
- Medical subject headings
- Graves Disease, Graves Ophthalmopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Atorvastatin 40 mg is administered orally once daily for 12 months, in addition to standard treatment for Graves' disease.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | 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. |
| Atorvastatin + Standard Care | Experimental | 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. Receives: Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after randomization
Secondary outcomes (9)
Development of Active Graves' Orbitopathy at 3, 6, 9, 15, and 18 Months
Proportion of participants who develop active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3, as assessed by standardized ophthalmological evaluation.
Measured: 3, 6, 9, 15, and 18 months after randomization
Genetic Factors Associated With Response to Atorvastatin
Genotype frequencies for CYR61 rs3753793 and rs12756618, ZFP36 rs1057745, SCD rs1393491, CTLA4 rs231775, TSHR rs179247, and SLCO1B1 rs4149056 will be determined. Genotype frequencies will be compared between participants with and without active Graves' ophthalmopathy, defined as a Clinical Activity Score (CAS) ≥3 at 12 months.
Measured: Baseline (genotyping) and 12 months (CAS)
Time to Development of Active Graves' Orbitopathy
Time from GD diagnosis to the first occurrence of active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3.
Measured: From diagnosis through 18 months
Correlations between circulating biomarker levels and Graves' ophthalmopathy clinical activity score
Spearman's rank correlation coefficients will be calculated separately for each circulating biomarker and the seven-item Clinical Activity Score (CAS) at each visit.
The biomarker panel comprises multimerin-1 (MMRN1), IgG Fc-binding protein (FCGBP), cadherin-5 (CDH5), complement factor H-related protein 5 (CFHR5), apolipoprotein D (APOD), C-X-C motif chemokine ligand 10 (CXCL10/IP-10), and interleukin-6 (IL-6). These analyses are exploratory.
Measured: Baseline, 3 months, 12 months, and 18 months
Maximum Clinical Activity Score During Follow-up
The highest Clinical Activity Score (CAS) recorded for each participant during the study follow-up period. Higher scores indicate greater inflammatory activity of Graves' orbitopathy.
Measured: From randomization through 18 months
Need for Treatment for Graves' Orbitopathy
Proportion of participants requiring treatment for Graves' orbitopathy, including systemic glucocorticoids, orbital radiotherapy, biologic treatment, or other disease-specific treatment because of development or progression of Graves' orbitopathy.
Measured: From randomization through 18 months
Change in Graves' Orbitopathy-Specific Quality of Life
Change in Graves' orbitopathy-related quality of life assessed using the Graves' Orbitopathy Quality of Life questionnaire (GO-QoL). The questionnaire assesses visual functioning and appearance-related impact of Graves' orbitopathy.
Measured: Baseline, 12 months, and 18 months
Change in Thyroid-Related Quality of Life
Change in thyroid-related symptoms and quality of life assessed using the ThyPRO questionnaire.
Measured: Baseline, 12 months, and 18 months
Change in Thyrotropin Receptor Antibody Levels
Change in serum thyrotropin receptor antibody (TRAb) levels from baseline during follow-up.
Measured: Baseline, 6, 12, 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2032 (estimated)
- Study completion1 May 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tereza Planck, Principal investigator, Region Skåne, Endokrinologimottagning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883356
- Sponsor's protocol ID
- ATORGO
- Other IDs
- 2023-504654-35-00, 2023
- Acronym
- ATORGO
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
- ClinicalTrials.gov ID
- NCT07883356
- Acronym / sponsor ID
- ATORGO / ATORGO
- Conditions
- Graves Disease, Graves Disease (Basedow's Disease), Graves Orbitopathy, Graves Ophthalmopathy, Graves' Orbitopathy, Graves' Disease
- Keywords
- Graves' disease, Graves' orbitopathy, Thyroid eye disease, thyroid-associated ophthalmopathy, thyroid-assoaciated orbitopathy, Atorvastatin, statin, Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2032 (estimated)
- Study completion
- 1 May 2033 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Graves' disease (GD) is an autoimmune thyroid disorder in which stimulating antibodies against the thyrotropin receptor cause hyperthyroidism. Graves' orbitopathy (GO), also referred to as thyroid eye disease, is the most important extrathyroidal manifestation of GD. GO may cause pain, swelling, redness, proptosis, diplopia, impaired quality of life, and, in severe cases, visual impairment. Although treatment of established GO has improved, there are currently limited options for preventing the development of GO in patients with newly diagnosed GD.
Observational studies have suggested that treatment with statins may be associated with a lower risk of developing GO in patients with GD. Statins have anti-inflammatory and immunomodulatory effects in addition to their lipid-lowering properties, providing a biological rationale for evaluating whether statin treatment can prevent GO. However, the preventive effect of statins has not been established in a sufficiently large randomized controlled trial.
ATORGO is a multicenter, randomized, controlled clinical trial designed to evaluate whether treatment with atorvastatin reduces the risk of developing active GO in adults with newly diagnosed GD. Participants are randomized in a 1:1 ratio to receive atorvastatin 40 mg once daily for 12 months in addition to standard treatment for GD, or standard treatment for GD alone.
Participants are followed for 18 months after randomization. Clinical assessments are performed at predefined study visits and include evaluation of thyroid disease and signs and symptoms of GO. Eye assessments include standardized documentation of clinical findings and photographs. To reduce the risk of assessment bias, relevant ophthalmic outcomes are evaluated by assessors who are blinded to treatment allocation using standardized photographic documentation where applicable.
Blood samples are collected during follow-up to assess thyroid function, thyrotropin receptor antibodies, and other study-related biomarkers. Patient-reported outcomes are assessed using validated questionnaires addressing thyroid-related and GO-related symptoms and quality of life.
The main objective is to determine whether adding atorvastatin to standard GD treatment reduces the development of active GO compared with standard GD treatment alone. Additional analyses will evaluate the timing and severity of GO, the need for GO-specific treatment, changes in thyroid autoimmunity, patient-reported outcomes, and potential biological markers associated with the development of GO or response to treatment.
The study is intended to provide evidence on whether a widely available, inexpensive, and well-established medication can be repurposed to prevent GO in patients with newly diagnosed GD.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –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. |
| Atorvastatin + Standard Care | Experimental | Drug: AtorvastatinParticipants 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
- 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.
- Existing Graves' ophthalmopathy at the time of Graves' disease diagnosis.
- Known hypersensitivity to atorvastatin or other statins.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AtorvastatinAtorvastatin 40 mg is administered orally once daily for 12 months, in addition to standard treatment for Graves' disease. | Drug | Atorvastatin + Standard Care |
Primary outcome
Development of Active Graves' Orbitopathy
Time frame: 12 months after randomization
Proportion of participants who develop active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3, as assessed by standardized ophthalmological evaluation.
9 secondary outcomes
Development of Active Graves' Orbitopathy at 3, 6, 9, 15, and 18 Months
Time frame: 3, 6, 9, 15, and 18 months after randomization
Genetic Factors Associated With Response to Atorvastatin
Time frame: Baseline (genotyping) and 12 months (CAS)
Time to Development of Active Graves' Orbitopathy
Time frame: From diagnosis through 18 months
Correlations between circulating biomarker levels and Graves' ophthalmopathy clinical activity score
Time frame: Baseline, 3 months, 12 months, and 18 months
Maximum Clinical Activity Score During Follow-up
Time frame: From randomization through 18 months
Need for Treatment for Graves' Orbitopathy
Time frame: From randomization through 18 months
Change in Graves' Orbitopathy-Specific Quality of Life
Time frame: Baseline, 12 months, and 18 months
Change in Thyroid-Related Quality of Life
Time frame: Baseline, 12 months, and 18 months
Change in Thyrotropin Receptor Antibody Levels
Time frame: Baseline, 6, 12, 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tereza Planck principal investigator
Region Skåne, Endokrinologimottagning
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Graves Disease and Graves Disease (Basedow's Disease), run by Region Skane at 7 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tereza Planck, MD, PhD (+46-40-337276, tereza.planck@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of Active Graves' Orbitopathy (time frame: 12 months after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.