Subcutaneous Semaglutide in Systemic Scleroderma

Last updated: March 2, 2024
Sponsor: Second Xiangya Hospital of Central South University
Overall Status: Active - Recruiting

Phase

1

Condition

Scar Tissue

Treatment

Semaglutide Pen Injector

Clinical Study ID

NCT06149260
LYG2022061
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:(Those who have not achieved good results after hormone orimmunosuppressive therapy)

  1. Gender unlimited;
  2. Age 18-65 years old (including 65 years old);
  3. Patients diagnosed with SSc who meet the 2013 European Union Against Rheumatology (EULAR)/American Society of Rheumatology (ACR) SSc diagnostic classification criteriaand exclude infections, tumors, and other connective tissue diseases.
  4. Has received one or more of the following standard systemic treatments allowed by theresearch protocol:
  5. Before the first subcutaneous injection of the study, oral corticosteroids (prednisone not exceeding 15mg/d or equivalent) were administered for ≥ 8 weeks,and stabilizers were administered for ≥ 4 weeks.
  6. Before the first subcutaneous injection of the study, patients were treated withTofacitinib (5-10mg/d) for ≥ 8 weeks and received a stabilizer dose for ≥ 6weeks.
  7. If one or more of the following immune modulators are used, treatment must begiven for ≥ 12 weeks before the start of the study, and treatment with astabilizer dose must be given for ≥ 6 weeks Oral mycophenolate mofetil (MMF) ≤ 1.5 g/day Methotrexate (MTX) oral ≤ 15 mg/week, combined with folic acidCyclosporine If the subjects use ≥ 2 of the above immunomodulatory drugs incombination, the appropriateness of the subjects' participation in the study mustbe discussed with the medical supervisor and study chair before enrollment.
  8. A modified Rodnan Skin Score (mRSS) of > 14
  9. Those who sign an informed consent form, voluntarily participate in this project, andare able to complete follow-up as required.

Exclusion

Exclusion Criteria:

  1. Prior to the first dose, Body Mass Index (BMI) < 18.5 kg/m2; weight loss of 10% withinone month or 20% within six months.
  2. Family or personal history of type 2 multiple endocrine neoplasia or medullary thyroidcarcinoma, with family history involving first-degree relatives.
  3. History of malignant tumors or a history of malignant tumors within the past 5 yearsbefore screening.
  4. Presence of other inflammatory diseases that may interfere with efficacy assessment,including but not limited to rheumatoid arthritis (RA), overlap syndrome, psoriasis,dermatomyositis, multiple sclerosis, Crohn's disease, or active Lyme disease.
  5. Severe gastrointestinal complications of systemic sclerosis (SSc), such as significantswallowing difficulties, and severe diseases affecting vital organ systems such as theheart, brain, lungs, liver, kidneys, or blood, as deemed unsuitable for participationin the study by the investigator.
  6. Known current active or recurrent severe infections, including active tuberculosis.
  7. Congenital immunodeficiency or congenital immunosuppression.
  8. Substance abuse, alcoholism, or psychiatric disorders, rendering patientsuncooperative or unable to adhere to treatment; poor predictability of compliance.
  9. Women who are pregnant, breastfeeding, or planning to become pregnant.
  10. Patients currently participating in other clinical trials.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Semaglutide Pen Injector
Phase: 1
Study Start date:
February 29, 2024
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • the Second Xiangya Hospital

    Changsha, Hunan 410011
    China

    Active - Recruiting

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