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KE, L-Lys-L-Glu, lysylglutamic acid

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Recruiting PHASE1 INTERVENTIONAL NCT06149260

Subcutaneous Semaglutide in Systemic Scleroderma

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis

Detailed Description

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.

Interventions

Name: Semaglutide Pen Injector

Type: DRUG

Description: 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.

Primary Outcomes

Measure: Change in modified Rodnan skin score (mRSS) at week 24

TimeFrame: Baseline and 24 weeks

Description: 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)

Trial Information

NCT ID

NCT06149260

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Second Xiangya Hospital of Central South University

Last Updated

December 15, 2025

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Semaglutide Vilon