This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis
Systemic Sclerosis (Ssc) is a rare, systemic autoimmune disease characterized by skin fibrosis and vasculopathy. In addition to the skin, it is a heterogeneous disease that affects multiple organs, including the cardiac, pulmonary, and gastrointestinal systems. This is a small prospective and open-label clinical trial of semaglutide in adults with systemic slceorsis. 10 systemic sclerosis patients will be recruited and receive semaglutide for 24 weeks. The primary endpoint of the study is the change in mRSS at 24 weeks of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Inject semaglutide subcutaneously once weekly, on the same day each week, at any time of day, in a dose increasing mode: the initial dose of 0.25mg QW (once a week), increased to 0.5mg QW after 4 weeks, and then maintained 0.5mg until the end of treatment in total 24 weeks.
the Second Xiangya Hospital
Changsha, Hunan, China
RECRUITINGChange in modified Rodnan skin score (mRSS) at week 24
Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0. To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)
Time frame: Baseline and 24 weeks
Incidence of Adverse Events
Time frame: Baseline and 24 weeks
Incidence of Severe Adverse Events
Time frame: Baseline and 24 weeks
the scleroderma health assessment questionnaire-disability index (sHAQ-DI)
Time frame: Baseline and 24 weeks
High-resolution computer tomography (HRCT)
Time frame: Baseline and 24 weeks
Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO)
Time frame: Baseline and 24 weeks
St George' s Respiratory Questionnaire(SGRQ)
Time frame: Baseline and 24 weeks
Pulmonary arterial hypertension by echocardiography
Time frame: Baseline and 24 weeks
left ventricular ejection fraction by echocardiography
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Time frame: Baseline and 24 weeks
6-Minute Walk Test (6MWT) Distance
Time frame: Baseline and 24 weeks
gastrointestinal tract (GIT) in scleroderma score
Time frame: Baseline and 24 weeks