NCT06149260

Subcutaneous Semaglutide in Systemic Scleroderma

An Open-lable Trial of Subcutaneous Semaglutide in Systemic Scleroderma

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Second Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Scleroderma, Systemic
• Fibrosis
• Semaglutide

Interventions

Type	Name	Description
DRUG	Semaglutide Pen Injector	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.

Timeline

• Start date: 2024-02-29
• Primary completion: 2024-08-29
• Completion: 2024-12-01
• First posted: 2023-11-28
• Last updated: 2024-03-05

Locations

1 site across 1 country: China