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Subcutaneous Semaglutide in Systemic Scleroderma
An Open-lable Trial of Subcutaneous Semaglutide in Systemic Scleroderma
Asset
Semaglutide
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
10
estimated
Study population
—
Key I/E criterion
—
Primary endpoint
•Modified Rodnan skin score (mRSS)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Eligibility
Who can enroll
Inclusion criteria
(Those who have not achieved good results after hormone or immunosuppressive 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 criteria and exclude infections, tumors, and other connective tissue diseases.
4. Has received one or more of the following standard systemic treatments allowed by the research protocol:
1. 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.
2. Before the first subcutaneous injection of the study, patients were treated with Tofacitinib (5-10mg/d) for ≥ 8 weeks and received a stabilizer dose for ≥ 6 weeks.
3. If one or more of the following immune modulators are used, treatment must be given for ≥ 12 weeks before the start of the study, and treatment with a stabilizer dose must be given for ≥ 6 weeks Oral mycophenolate mofetil (MMF) ≤ 1.5 g/day Methotrexate (MTX) oral ≤ 15 mg/week, combined with folic acid Cyclosporine If the subjects use ≥ 2 of the above immunomodulatory drugs in combination, the appropriateness of the subjects' participation in the study must be discussed with the medical supervisor and study chair before enrollment.
5. A modified Rodnan Skin Score (mRSS) of > 14
6. Those who sign an informed consent form, voluntarily participate in this project, and are able to complete follow-up as required.
Exclusion criteria
1. Prior to the first dose, Body Mass Index (BMI) < 18.5 kg/m2; weight loss of 10% within one month or 20% within six months.
2. Family or personal history of type 2 multiple endocrine neoplasia or medullary thyroid carcinoma, with family history involving first-degree relatives.
3. History of malignant tumors or a history of malignant tumors within the past 5 years before 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 significant swallowing difficulties, and severe diseases affecting vital organ systems such as the heart, brain, lungs, liver, kidneys, or blood, as deemed unsuitable for participation in 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 patients uncooperative 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.
Endpoints (11)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Heart failure
2 endpointsleft ventricular ejection fraction by echocardiography
Time frame:Baseline and 24 weeks
change from baseline, improvement
6-Minute Walk Test (6MWT) Distance
Time frame:Baseline and 24 weeks
6-minute walk distance
change from baseline, improvement
Patient-reported / QoL
2 endpointsthe scleroderma health assessment questionnaire-disability index (sHAQ-DI)
Time frame:Baseline and 24 weeks
change from baseline, improvement
St George' s Respiratory Questionnaire(SGRQ)
Time frame:Baseline and 24 weeks
change from baseline, improvement
Safety / tolerability / PK
2 endpointsIncidence of Adverse Events
Time frame:Baseline and 24 weeks
Treatment-emergent AEs (any)
event count, event
Incidence of Severe Adverse Events
Time frame:Baseline and 24 weeks
Serious AEs (any)
event count, event
Other clinical outcomes
4 endpointsChange in modified Rodnan skin score (mRSS) at week 24
Time frame:Baseline and 24 weeks
change from baseline, improvement
Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO)
Time frame:Baseline and 24 weeks
change from baseline, improvement
componentsforced vital capacity fvc, dlco diffusing capacity carbon monoxide
Pulmonary arterial hypertension by echocardiography
Time frame:Baseline and 24 weeks
descriptive
gastrointestinal tract (GIT) in scleroderma score
Time frame:Baseline and 24 weeks
change from baseline, improvement
Other (unclassified)
1 endpointHigh-resolution computer tomography (HRCT)
Time frame:Baseline and 24 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.