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T2DM
CompletedPhase 2UBT251 Injection Phase II (Type 2 Diabetes Mellitus) Study
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Patients With Type 2 Diabetes Mellitus
Lead sponsor
Assets
Semaglutide / UBT251
Listed sites
1
Recruiting sites
—
Enrollment
211
actual
Study population
Type 2 diabetes
Key I/E criteria
•BMI 23-40•HbA1c 7-10.5%
Primary endpoint
•HbA1c, change
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
Exclusion criteria
1. Any antihyperglycemic agent other than metformin within 3 months before screening, including GLP-1 analogues, oral antidiabetics, insulin, Chinese herbal medicines or health products with glucose-lowering effects.
2. Systemic glucocorticoids, growth hormone, or any drug that may affect glucose metabolism within 3 months before screening.
3. Any weight-loss medication within 3 months before screening.
1. Diabetes other than type 2 (e.g., type 1 diabetes, specific types of diabetes).
2. Acute or chronic pancreatitis, or history of pancreatic surgery.
3. Symptomatic gallbladder disease within 2 years before screening (imaging-confirmed gallstones with physician-diagnosed related abdominal pain); subjects with prior cholecystectomy without sequelae may be included.
4. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
5. Hematologic disorders that may interfere with HbA1c measurement or increase subject risk, or any disease causing hemolysis or red-cell instability.
6. History of depression or severe psychiatric disorders including suicidal ideation/attempt, schizophrenia, or bipolar disorder.
7. Clinically significant active cardiovascular or cerebrovascular disease within 6 months before screening: myocardial infarction or unstable angina; cardiac surgery; congestive heart failure; cerebrovascular accident including stroke/TIA; any other cardiovascular/cerebrovascular condition deemed unsuitable by the investigator.
8. Retinopathy requiring urgent treatment at screening.
9. History of severe hypoglycemic coma or recurrent hypoglycemia within 2 months before randomization.
10. Diabetic acute metabolic complications or diabetic foot within 6 months before screening.
11. Gastroparesis or other disorders associated with delayed gastric emptying, uncontrolled gastro-esophageal reflux disease, or any gastrointestinal condition that, in the investigator's opinion, increases risk after study drug administration.
12. Major surgery, severe trauma, or severe infection within 1 month before screening judged by the investigator to preclude study participation.
13. History of malignancy (except adequately treated basal-cell carcinoma or carcinoma in situ of the cervix).
14. Concurrent medical conditions (neurologic, endocrine, psychiatric, etc.) that, in the investigator's opinion, could compromise subject safety, affect efficacy assessments, or interfere with compliance.
1. Fasting C-peptide <0.81 ng/mL.
2. Hepatic or renal impairment: ALT and/or AST ≥2.5×ULN; total bilirubin ≥1.5×ULN; eGFR <60 mL·min-¹·1.73 m-².
3. Serum calcitonin ≥50 pg/mL.
4. Unstable thyroid medication requirement or clinically significant abnormal thyroid function tests necessitating new treatment.
5. Fasting triglycerides ≥5.6 mmol/L.
6. Serum amylase and/or lipase >2.0×ULN.
7. INR above the upper limit of normal.
8. Hemoglobin <110 g/L (males) or <100 g/L (females).
9. Uncontrolled or untreated hypertension.
10. Clinically significant ECG abnormalities: second- or third-degree AV block; long-QT syndrome or QTcF >470 ms (female) or >450 ms (male); pre-excitation syndrome; or any severe arrhythmia requiring treatment.
11. Any physical examination, vital sign, or laboratory abnormality that, in the investigator's judgment, poses significant risk to the subject or may interfere with safety, PK, or PD evaluations.
Endpoints (13)
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
2 endpointsChange in body weight from baseline to week 12, 24
Time frame:Week 12, 24
Body weight, absolute change (kg)
change from baseline, improvement
Change in waist circumference from baseline to week 12, 24
Time frame:Week 12, 24
Waist circumference, change
change from baseline, improvement
Glycemic / diabetes
8 endpointsChange From Baseline in HbA1c at Week 24
Time frame:Baseline to week 24
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change Change from baseline to week 12, 16, 20 in HbA1c
Time frame:Week 12, 16, 20
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in venous fasting plasma glucose (FPG) from baseline to week 12, 16, 20, 24
Time frame:Week 12, 16, 20, 24
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in 2-hour post-standard-meal plasma glucose from baseline to week 12, 24
Time frame:Week 12, 24
Postprandial glucose
change from baseline, improvement
HbA1c target achievement rates (<7.0%) at Week 24
Time frame:Week 24
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
HbA1c target achievement rates (≤6.5%) at Week 24
Time frame:Week 24
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
FPG target achievement rate (4.4-7.0 mmol/L) at Week 24
Time frame:Week 24
Fasting glucose, change
threshold achievement, improvement
LOINC 1558-6
Combined target achievement rate for both HbA1c and FPG at Week 24
Time frame:Week 24
threshold achievement, improvement
componentsHbA1c <7.0% achievement, Fasting glucose, change
Cardiometabolic biomarkers
3 endpointsChange from baseline to week 24 in fasting lipid profile
Time frame:Week 24
change from baseline, improvement
Change from baseline to week 24 in systolic blood pressure
Time frame:Week 24
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Change from baseline to week 24 in diastolic blood pressure
Time frame:Week 24
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
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.