Chronic kidney disease patients who are obese/overweight
Conditions
Interventions
4.0 mg group:If the subject cannot tolerate this dose after titrations to 4.0 mg/time, and the investigator assesses that the subject cannot tolerate continued exposure, the dose may be reduced to 2.0
If the dose is not tolerated after increasing to 4.0 mg/dose and the investigator believes that the subject cannot tolerate continued exposure, the dose may be adjusted back to 2.0 mg/dose and maintai
2.0 mg group:If the subject cannot tolerate this dose after titrationation to 2.0 mg/time, and the subject is assessed by the investigator to be unable to tolerate continued exposure, the dose may be
6.0 mg group:If the subject cannot tolerate this dose after titrationation to 6.0 mg/fro and the investigator assesses that the subject cannot tolerate continued exposure at this dose, the dose may be
or continue to increase to 6.0 mg/fraction after 2 weeks of 5.0 mg/titration according to the subject
If the subject remains intolerant at a dose of 5.0 mg/time and the investigator assesses that the subject cannot tolerate continued exposure, the dose may be reduced to 4.0 mg/time and the dose may be
If not tolerated, the dose is adjusted back to 4.0 mg/dose and maintained until the end of the study.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18~75 years old (including border value), BMI >=24 kg/m^2, gender is not limited. 2. Subject estimated glomerular filtration rate (eGFR): >=45 and =4 weeks is required unless there are contraindications or intolerance. (For subjects who are intolerant to the above drugs, they can still be included if judged by the investigator to be suitable to participate in the investigator.) ) 5. Volunteer to participate in the study and sign the ICF. 6. Female of childbearing potential or male subjects with partners of childbearing potential agree to use effective contraception from the start of study treatment until 3 months after the end of the last dose.
Exclusion criteria
Exclusion criteria: 1. History or evidence of any of the following diseases: 1) Diagnosis of type 1 diabetes or other special type diabetes. 2) Presence of non-recovered acute kidney injury (AKI) at screening. 3) Previous or current suffering: bilateral renal artery stenosis (stenosis>=50%), tubulointerstitial nephritis, lupus nephritis, autosomal dominant polycystic kidney disease (ADPKD) and autosomal recessive polycystic kidney disease (ARPKD), anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, unilateral nephrectomy or other severe renal structural abnormalities, and a history of unstable or rapidly progressing kidney disease as judged by the investigator. 4) Poorly controlled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg at screening). 5) Glycated hemoglobin (HbA1c) >= 9.5%. 6) Presence of serious illness or medical condition judged by the investigator during the screening period, including but not limited to: a) History of malignant tumor disease within 5 years prior to screening (except for cured basal cell or squamous cell carcinoma of the skin and carcinoma in situ at any site); b) Arterial/venous thrombotic events within 6 months prior to screening, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction [except old lacunar cerebral infarction]), deep vein thrombosis; c) History of internal myocardial infarction or surgery such as percutaneous coronary intervention and coronary artery bypass grafting 6 months before screening; d) History of internal heart failure 6 months prior to screening, with New York Heart Association (NYHA) functional class III. or IV. 7) Combined with gastroparesis or other diseases related to gastrointestinal emptying disorders (such as pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, gastrointestinal diseases assessed by the investigator as increasing the risk after medication (such as severe active ulcers, inflammatory bowel disease, acute gastroenteritis, symptomatic chronic gastroenteritis), or undergoing major upper gastrointestinal surgery. 8) History of pancreatitis or pancreatic injury, or pancreatic surgery. 9) History of symptomatic gallbladder disease within 2 years prior to screening, defined as imaging examination suggesting the presence of gallstones and diagnosis-related symptoms related to gallstones; Subjects who have undergone gallstone surgery and/or cholecystectomy (surgery completed at least 3 months prior to screening) with no long-term complications may participate in this study. 10) History or family history of medullary thyroid carcinoma (MTC), multiple endocrine neoplasia (MEN) type 2. 11) History of acute complications of diabetes (diabetic ketoacidosis, diabetic lactic acidosis, hyperglycemic hyperosmolar state, etc.) within 6 months prior to screening. 12) Severe retinal and macular degeneration (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) in the past or at screening, which require further urgent treatment as judged by the investigator. 13) Severe chronic complications of diabetes (including but not limited to severe diabetic neuropathy, diabetic foot, etc.) at screening, and the investigator judges that this complication may affect the compliance and safety of the subjects. 14) Severe hypoglycemia or recurrent symptomatic hypoglycemia within 6 months prior to screening (>=2 ti
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change in log-transformed UACR from baseline after 24 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in log-transformed UACR after 12 weeks of treatment;After 12 weeks and 24 weeks of treatment, the change of 24-hour urine protein quantification from baseline;Change from baseline in eGFR after 12 weeks and 24 weeks of treatment;After 12 weeks and 24 weeks of treatment, the proportion of subjects with a reduction of >=30%, >=40%, and >=50% compared with the baseline UACR geometric mean;Change from baseline in serum creatinine after 12 weeks and 24 weeks of treatment;Change in body weight from baseline after 12 weeks and 24 weeks of treatment;Change from baseline in EQ-5D-5L score and EQ-VAS score after 24 weeks of treatment; | — |
Countries
China
Contacts
Public ContactMinghui Zhao;Min Chen
Peking University First Hospital
Outcome results
None listed