Systemic Lupus Erythematosus
Conditions
Interventions
Med Group:Mashidu peptide is administered via subcutaneous injection. The treatment course is 24 weeks, once a week, for a total of 12 doses. The dose is titrated to 2 mg over 4 weeks, then maintained
Sponsors
Ruijin Hospital: Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria are eligible for inclusion in this study: 1.Must be able to understand and voluntarily sign a written informed consent form. 2.Diagnosed with active SLE, meeting the 2019 EULAR/ACR SLE classification criteria at the time of diagnosis. 3.Aged 18–65 years, both male and female, with no restriction on gender ratio. 4.Hospitalized or outpatient patients with good compliance, having signed the informed consent form prior to the trial. 5.SELENA-SLEDAI score =6 points during the screening period. 6.Have poorly controlled diabetes or BMI >=28 kg/m² or BMI>=23 kg/m² combined with >=1 weight-related comorbidity (including dyslipidemia, hyperuricemia, hypertension, obstructive sleep apnea, fatty liver disease, etc.). 7.Female subjects must meet the following criteria: (1) Surgically sterilized or postmenopausal for >=2 years, or a woman of childbearing potential (the latter includes those postmenopausal for <2 years), with a negative pregnancy test, and willing to use effective contraception (e.g., condoms, spermicides, or intrauterine devices) during the study and for at least 90 days after the last study dose. Progesterone-containing contraceptives are not permitted. (2) Agree not to breastfeed during the study and for at least 90 days after the last study dose. 8.Male subjects must meet the following criteria: If not surgically sterilized and likely to engage in sexual activity that could result in pregnancy, agree to use effective contraception (e.g., condoms, spermicides) during the study and for at least 90 days after the last study dose. 9.Glycated hemoglobin less than 9%.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria will be excluded from this study: 1.Allergy to mazdutide; 2.History of pancreatitis or previous medullary thyroid carcinoma; 3.Abnormal laboratory results requiring exclusion include but are not limited to the following: (1) ALT or AST >= 3 × ULN (upper limit of normal); (2) Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m² or creatinine clearance (CrCl) < 30 mL/min; 4.Immunodeficiency or uncontrolled severe infection; 5.Pregnant or lactating women, or individuals (male or female) planning to conceive during the trial; 6.Receipt of a live vaccine within 28 days prior to randomization; 7.Participation in any other clinical trial within 28 days prior to randomization or within 5 half-lives of the investigational drug from a previous trial (whichever is longer); 8.Active infection during the screening period (e.g., herpes zoster, HIV infection, active tuberculosis, etc.); 9.Psychiatric disorders with depression or suicidal ideation; 10.Any other condition deemed by the investigator as inappropriate for participation in this trial; 11.Current treatment regimen includes biologic agents such as rituximab, belimumab, telitacicept, obinutuzumab, etc.; 12.Planned use of biologic agents such as rituximab, belimumab, telitacicept, obinutuzumab, etc., within the next 12 weeks; 13.Previous or current use of GLP-1 receptor agonists.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SLE Responder Index, SRI; | — |
Countries
China
Contacts
Public ContactJunna Ye
Ruijin Hospital: Shanghai Jiao Tong University Medical School Affiliated Ruijin Hospital
Outcome results
None listed