Subcutaneous Semaglutide in Systemic Scleroderma

Sponsor
Second Xiangya Hospital of Central South University
Study ID
NCT06149260
Phase
PHASE1
Status
Unknown

Conditions

  • Fibrosis
  • Scleroderma, Systemic
  • Semaglutide

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Semaglutide Pen Injector — DRUG
    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.

Study Details

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

Key Dates

Start date
Feb 29, 2024
Status verified
Mar 2024
Primary completion
Aug 29, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide
    Participants will receive once-weekly semaglutide subcutaneous injection at escalating doses from 0.25 mg/week to 0.5 mg/week.

Primary Outcome Measure

Change in modified Rodnan skin score (mRSS) at week 24 [ Time Frame: Baseline and 24 weeks ]

Central Contacts

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