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Trial · NCT07883356

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

NCT07883356, Phase 2, Not yet recruiting, Region Skane

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO). Trials, record NCT07883356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07883356

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
NCT number
NCT07883356
Status
Not yet recruiting
Phases
Phase 2
Enrollment
554 participants, estimated
Lead sponsor
Region Skane
Conditions
Graves Disease, Graves Disease (Basedow's Disease), Graves Orbitopathy, Graves Ophthalmopathy, Graves' Orbitopathy, Graves' Disease, Graves' Hyperthyroidism, Graves´ Disease, Graves´ Ophthalmopathy, Graves' Ophthalmopathy (GO), Thyroid Eye Disease, Thyroid Eye Disease, TED, Thyroid-Associated Ophthalmopathy
Interventions
Atorvastatin
First posted
2026-10-20
Last updated
2026-10-20

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryDevelopment of Active Graves' Orbitopathy12 months after randomizationProportion of participants who develop active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3, as assessed by standardized ophthalmological evaluation.
SecondaryDevelopment of Active Graves' Orbitopathy at 3, 6, 9, 15, and 18 Months3, 6, 9, 15, and 18 months after randomizationProportion of participants who develop active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3, as assessed by standardized ophthalmological evaluation.
SecondaryGenetic Factors Associated With Response to AtorvastatinBaseline (genotyping) and 12 months (CAS)
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.
SecondaryTime to Development of Active Graves' OrbitopathyFrom diagnosis through 18 monthsTime from GD diagnosis to the first occurrence of active Graves' orbitopathy, defined as a Clinical Activity Score (CAS) ≥3.
SecondaryCorrelations between circulating biomarker levels and Graves' ophthalmopathy clinical activity scoreBaseline, 3 months, 12 months, and 18 months
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.
SecondaryMaximum Clinical Activity Score During Follow-upFrom randomization through 18 monthsThe highest Clinical Activity Score (CAS) recorded for each participant during the study follow-up period. Higher scores indicate greater inflammatory activity of Graves' orbitopathy.
SecondaryNeed for Treatment for Graves' OrbitopathyFrom randomization through 18 months
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.
SecondaryChange in Graves' Orbitopathy-Specific Quality of LifeBaseline, 12 months, and 18 months
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.
SecondaryChange in Thyroid-Related Quality of LifeBaseline, 12 months, and 18 monthsChange in thyroid-related symptoms and quality of life assessed using the ThyPRO questionnaire.
SecondaryChange in Thyrotropin Receptor Antibody LevelsBaseline, 6, 12, 18 monthsChange in serum thyrotropin receptor antibody (TRAb) levels from baseline during follow-up.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07883356

GET https://conductscience.org/api/trials/v1/NCT07883356/registered