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UBT251 Injection Phase II Clinical Study (CKD)
A Phase II Clinical Study to Evaluate the Efficacy and Safety of UBT251 Injection in Obese/Overweight Chronic Kidney Disease (CKD) Population
Lead sponsor
Asset
UBT251
Subcutaneous · GLP-1 / GIP / glucagon triple
Listed sites
1
Recruiting sites
1
Enrollment
180
estimated
Study population
Chronic kidney disease, Obesity / overweight
Key I/E criteria
•BMI ≥24•eGFR 45-90•UACR ≤5000
Primary endpoint
•Log-transformed urinary albumin:creatinine ratio(UACR)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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 < 90 mL/min/1.73m^2 (calculated using the CKD-EPI formula).
3. Subjects 300 mg/g <= UACR <= 5000 mg/g 3 months or more prior to screening; At least 2 measurements (not on the same day) within 4 weeks of the screening period, and each measurement must meet this criterion.
4. If treated with SGLT2i, angiotensin-converting enzyme inhibitors (ACEi), angiotensin receptor blockers (ARBs), mineralocorticoid receptor antagonists (MRAs) before screening, a stable dose of >=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
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:
2. Medication history within 3 months prior to randomization that meets any of the following conditions: 1) Receive dipeptidyl peptidase 4 (DPP-4) inhibitors, amylin analogues, glucagon-like peptide-1 (GLP-1) analogues, glucose-dependent insulinic polypeptide (GIP) analogues, glucagon (GCG) analogues. 2) Systemic use of steroid glucocorticoids or immunosuppressants (except for topical or intraarticular, intranasal, and inhaled glucocorticoids; Short-term [<= 7 days] use of glucocorticoids for the prevention or treatment of non-autoimmune allergic diseases). 3) Use of over-the-counter weight loss drugs (including but not limited to orlistat) or food inhibitors (including traditional Chinese medicine), or treatment with lipid-dissolving injections (e.g., lipolysis injections) within 3 months prior to screening.
3. Those who have any of the following test abnormalities during screening: 1) Severe anemia (hemoglobin < 7.0 g/dL); 2) Abnormal liver function (ALT or AST >= 3 ×upper limit of normal [ULN], or serum total bilirubin [TBIL] >= 1.5 × ULN); 3) Serum albumin < 30 g/L; 4) Serum potassium > 5.5 mmol/L; 5) Fasting triglycerides >= 5.6 mmol/L; 6) International normalized ratio (INR) >= 1.5 × ULN; 7) Serum calcitonin level > 50 ng/L; 8) Serum amylase or lipase > 2.0× ULN. 9) Positive hepatitis B surface antigen (HBsAg) test and hepatitis B virus deoxyribonucleic acid (HBV-DNA) higher than the lower limit of detection, positive hepatitis C virus antibody test (HCV-Ab) and hepatitis C virus ribonucleic acid (HCV-RNA) above the upper limit of the reference value range, positive human immunodeficiency virus antibody (HIV-Ab) test at screening, syphilis antibody (TP- Ab) Those who test positive (RPR titer or TRUST test is required, except for cured syphilis). 10) Clinically significant electrocardiogram (ECG) abnormalities at screening (meeting one of them):
4. Body weight change of more than 5% within 6 weeks prior to screening.
5. Those who have had or plan to undergo bariatric surgery during the trial.
6. Those with a history of alcohol and drug abuse.
7. Those who are allergic to the study drug or its excipients.
8. Those who have participated in other clinical trials within 30 days before screening (except for screening only but not medicated or non-interventional studies) or within 5 half-lives of using investigational drugs, whichever is longer.
9. Subject is receiving dialysis/kidney transplantation or plans to undergo dialysis/kidney transplantation during the study.
10. Pregnant or lactating women.
11. Other conditions that the investigator considers unsuitable for participation in the study.
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
1 endpointbody weight
Time frame:12 weeks,24 weeks
descriptive
Renal / kidney
5 endpointslog-transformed urinary albumin:creatinine ratio(UACR)
Time frame:24 weeks
ratio, improvement
log-transformed urinary albumin:creatinine ratio (UACR)
Time frame:12 weeks
ratio, improvement
estimated glomerular filtration rate (eGFR)
Time frame:12 weeks,24 weeks
ratio, improvement
the proportion of subjects with a reduction of >=30%, >=40%, and >=50% compared with the baseline UACR geometric mean
Time frame:12 weeks,24 weeks
threshold achievement, improvement
serum creatinine
Time frame:12 weeks,24 weeks
descriptive
Patient-reported / QoL
1 endpointEQ-5D-5L score
Time frame:24 weeks
descriptive
Other (unclassified)
2 endpoints24-hour urine protein quantification
Time frame:12 weeks ,24 weeks
descriptive
EQ-VAS score
Time frame:24 weeks
descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.