Actively Recruiting
UBT251 Injection Phase II Clinical Study (CKD)
Led by The United Bio-Technology (Hengqin) Co., Ltd. · Updated on 2025-11-25
180
Participants Needed
1
Research Sites
253 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of UBT251 injection in obese/overweight chronic kidney disease (CKD) population
CONDITIONS
Official Title
UBT251 Injection Phase II Clinical Study (CKD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 75 years old
- Body mass index (BMI) of 24 kg/m² or higher
- Estimated glomerular filtration rate (eGFR) between 45 and 90 mL/min/1.73m²
- Urinary albumin:creatinine ratio (UACR) between 300 and 5000 mg/g measured at least twice within 4 weeks prior to screening, with measurements taken at least 3 months before screening
- Stable dose for at least 4 weeks of SGLT2 inhibitors, ACE inhibitors, ARBs, or MRAs if treated with these drugs, unless intolerant
- Willingness to participate and sign informed consent
- Agreement to use effective contraception during the study and for 3 months after last dose for females of childbearing potential and males with partners of childbearing potential
You will not qualify if you...
- Diagnosis of type 1 diabetes or other special types of diabetes
- Presence of unresolved acute kidney injury at screening
- History or current severe kidney diseases including bilateral renal artery stenosis (≥50%), tubulointerstitial nephritis, lupus nephritis, polycystic kidney diseases, ANCA-associated vasculitis, unilateral nephrectomy, or unstable/rapidly progressing kidney disease
- Poorly controlled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg)
- Glycated hemoglobin (HbA1c) ≥ 9.5%
- Serious illnesses such as recent malignant tumors, thrombotic events, myocardial infarction, heart failure (NYHA III/IV), or severe gastrointestinal diseases
- History of pancreatitis, pancreatic surgery, or symptomatic gallbladder disease within 2 years
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- Recent acute diabetes complications within 6 months
- Severe diabetic complications or hypoglycemia episodes
- Uncontrolled thyroid function or clinically significant thyroid abnormalities
- History of depression or severe mental illness
- Use of specific medications within 3 months prior including DPP-4 inhibitors, GLP-1 analogues, systemic steroids, or weight loss drugs
- Severe anemia, abnormal liver function, low serum albumin, abnormal potassium, high triglycerides, abnormal coagulation, elevated calcitonin, amylase or lipase
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- Significant ECG abnormalities
- Recent weight change over 5% in 6 weeks
- History or planned bariatric surgery
- History of alcohol or drug abuse
- Allergy to study drug or excipients
- Participation in other clinical trials within 30 days or 5 half-lives of investigational drugs
- Receiving or planning dialysis/kidney transplantation
- Pregnant or breastfeeding
- Any other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University First Hospital
Beijing, China
Actively Recruiting
Research Team
W
Wen Bian
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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