Scleroderma, SystemicPhase 1NCT06149260
Subcutaneous Semaglutide in Systemic Scleroderma
A Phase 1 study testing Semaglutide Pen Injector in people with Scleroderma, Systemic and Fibrosis, run by Second Xiangya Hospital of Central South University at 1 site in China.
Trial summary
This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Scleroderma, Systemic, Fibrosis, Semaglutide
- What is being tested?
- Semaglutide Pen Injector
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 29 Feb 2024to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
- 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.
- 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.
- 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.
- Known current active or recurrent severe infections, including active tuberculosis.
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- Congenital immunodeficiency or congenital immunosuppression.
- Substance abuse, alcoholism, or psychiatric disorders, rendering patients uncooperative or unable to adhere to treatment; poor predictability of compliance.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Patients currently participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the Second Xiangya Hospital
Changsha, Hunan, 410011
Rong Xiao, MD, +8618573185298, xiaorong65@csu.edu.cn
About this study
Official title: An Open-lable Trial of Subcutaneous Semaglutide in Systemic Scleroderma
This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis
Read the detailed 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.
- Conditions
- Scleroderma, Systemic, Fibrosis, Semaglutide
- Being tested
- Semaglutide Pen Injector
- Medical subject headings
- Scleroderma, Systemic, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide Pen InjectorDrug
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 group | Role | What they receive |
|---|---|---|
| Semaglutide | Experimental | Participants will receive once-weekly semaglutide subcutaneous injection at escalating doses from 0.25 mg/week to 0.5 mg/week. Receives: Drug: Semaglutide Pen Injector |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in modified Rodnan skin score (mRSS) at week 24
Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0.
To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)
Measured: Baseline and 24 weeks
Secondary outcomes (10)
Incidence of Adverse Events
Measured: Baseline and 24 weeks
Incidence of Severe Adverse Events
Measured: Baseline and 24 weeks
the scleroderma health assessment questionnaire-disability index (sHAQ-DI)
Measured: Baseline and 24 weeks
High-resolution computer tomography (HRCT)
Measured: Baseline and 24 weeks
Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO)
Measured: Baseline and 24 weeks
St George' s Respiratory Questionnaire(SGRQ)
Measured: Baseline and 24 weeks
Pulmonary arterial hypertension by echocardiography
Measured: Baseline and 24 weeks
left ventricular ejection fraction by echocardiography
Measured: Baseline and 24 weeks
6-Minute Walk Test (6MWT) Distance
Measured: Baseline and 24 weeks
gastrointestinal tract (GIT) in scleroderma score
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study start29 Feb 2024
- Primary completion29 Aug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scleroderma, SystemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Xiangya Hospital of Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rong Xiao, Second Xiangya Hospital of Central South University
- Investigators
- Rong Xiao, MD, Study chair, Department of Dermatology, Second Xiangya Hospital of Central South University, Changsha, ChinaLicong Liu, MD, Principal investigator, Second Xiangya HospitalYaqian Shi, MD, Principal investigator, Second Xiangya HospitalZhuotong Zeng, MD, Principal investigator, Second Xiangya HospitalZhan Yi, MD, Principal investigator, Second Xiangya HospitalXiangning Qiu, MD, Principal investigator, Second Xiangya HospitalRuixuan Zhu, MD, Principal investigator, Second Xiangya HospitalYi Wei, MD, Principal investigator, Second Xiangya Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149260
- Sponsor's protocol ID
- LYG2022061
- Status last verified
- Mar 2024
- First submitted
- 16 Nov 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-lable Trial of Subcutaneous Semaglutide in Systemic Scleroderma
- ClinicalTrials.gov ID
- NCT06149260
- Acronym / sponsor ID
- LYG2022061
- Conditions
- Scleroderma, Systemic, Fibrosis, Semaglutide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 29 Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will study the safety and efficacy of subcutaneous semaglutide for the treatment of Systemic Sclerosis
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Semaglutide | Experimental | Drug: Semaglutide Pen InjectorParticipants will receive once-weekly semaglutide subcutaneous injection at escalating doses from 0.25 mg/week to 0.5 mg/week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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.
- 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.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide Pen InjectorInject 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. | Drug | Semaglutide |
Primary outcome
Change in modified Rodnan skin score (mRSS) at week 24
Time frame: Baseline and 24 weeks
Change in modified Rodnan skin score (mRSS) at week 24 performed by the same investigator at week 0 and week 24 and the change in mRSS will be calculated following the formula: ΔmRSS= mRSSw24 - mRSSw0. To measure mRSS, skin thickness of the patient is rated by palpation at each of 17 anatomic sites using a scale of 0-3 (0 = normal skin; 1= mild thickness; 2= moderate thickness; 3=severe thickness with an inability to pinch the skin into a fold). The scores at each site are summed with a minimum of 0 and a maximum of 51 (17 sites)
10 secondary outcomes
Incidence of Adverse Events
Time frame: Baseline and 24 weeks
Incidence of Severe Adverse Events
Time frame: Baseline and 24 weeks
the scleroderma health assessment questionnaire-disability index (sHAQ-DI)
Time frame: Baseline and 24 weeks
High-resolution computer tomography (HRCT)
Time frame: Baseline and 24 weeks
Forced Vital Capacity(FVC) and Diffusing capacity of the lung for carbon monoxid(DLCO)
Time frame: Baseline and 24 weeks
St George' s Respiratory Questionnaire(SGRQ)
Time frame: Baseline and 24 weeks
Pulmonary arterial hypertension by echocardiography
Time frame: Baseline and 24 weeks
left ventricular ejection fraction by echocardiography
Time frame: Baseline and 24 weeks
6-Minute Walk Test (6MWT) Distance
Time frame: Baseline and 24 weeks
gastrointestinal tract (GIT) in scleroderma score
Time frame: Baseline and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Scleroderma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rong Xiao, MD study chair
Department of Dermatology, Second Xiangya Hospital of Central South University, Changsha, China
Licong Liu, MD principal investigator
Second Xiangya Hospital
Yaqian Shi, MD principal investigator
Second Xiangya Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Semaglutide Pen Injector in people with Scleroderma, Systemic and Fibrosis, run by Second Xiangya Hospital of Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rong Xiao, MD (13808425555, xiaorong65@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in modified Rodnan skin score (mRSS) at week 24 (time frame: Baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.