Subcutaneous Semaglutide in Systemic Scleroderma

What Was Tested

The trial (phase 1) is built around Semaglutide.

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

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.

Who Took Part

Enrollment: 10 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Age 18-65 years old (including 65 years old);. 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. Has received one or more of the following standard systemic treatments allowed by the research protocol:. A modified Rodnan Skin Score (mRSS) of \> 14. Those who sign an informed consent form, voluntarily participate in this project, and are able to complete follow-up as required.

The full record lists 9 inclusion and 10 exclusion criteria; among the exclusions: family or personal history of type 2 multiple endocrine neoplasia or medullary thyroid carcinoma, with family history involving first-degree relatives; history of malignant tumors or a history of malignant tumors within the past 5 years before screening; known current active or recurrent severe infections, including active tuberculosis.

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2024-02-29 with completion listed for 2024-08-29.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in modified Rodnan skin score (mRSS) at week 24 (time frame: Baseline and 24 weeks).

It also tracked 10 secondary outcomes, for example Incidence of Adverse Events, Incidence of Severe Adverse Events, the scleroderma health assessment questionnaire-disability index (sHAQ-DI), High-resolution computer tomography (HRCT), Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO) and St George' s Respiratory Questionnaire(SGRQ).

What This Means in Plain Language

Put simply, this is a phase 1 trial of Semaglutide in 10 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.