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UnknownPhase 1

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

NCT IDNCT06149260
Org study IDLYG2022061

Timeline

Milestones

Study first posted2023-11-28actual
Study start2024-02-29actual
Last update posted2024-03-05actual
Primary completion2024-08-29estimated
Study completion2024-12estimated (month precision)

Assets

Investigational agents

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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

Other clinical outcomes
4
Heart failure
2
Patient-reported / QoL
2
Safety / tolerability / PK
2
Other (unclassified)
1

Heart failure

2 endpoints
Secondary/protocol endpoint

left ventricular ejection fraction by echocardiography

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

6-Minute Walk Test (6MWT) Distance

Time frame:Baseline and 24 weeks

6-minute walk distance

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

the scleroderma health assessment questionnaire-disability index (sHAQ-DI)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

St George' s Respiratory Questionnaire(SGRQ)

Time frame:Baseline and 24 weeks

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

Incidence of Adverse Events

Time frame:Baseline and 24 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Incidence of Severe Adverse Events

Time frame:Baseline and 24 weeks

Serious AEs (any)

event count, event

Other clinical outcomes

4 endpoints
Primary/protocol endpoint

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

Time frame:Baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint/low confidence

Pulmonary arterial hypertension by echocardiography

Time frame:Baseline and 24 weeks

descriptive

Secondary/protocol endpoint

gastrointestinal tract (GIT) in scleroderma score

Time frame:Baseline and 24 weeks

change from baseline, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

High-resolution computer tomography (HRCT)

Time frame:Baseline and 24 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.