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UBT251 Injection Phase II Study (Overweight or Obesity)
A Phase II Study to Evaluate the Efficacy and Safety of UBT251 Injection in Overweight/Obese Patients
Lead sponsor
Asset
UBT251
Subcutaneous · GLP-1 / GIP / glucagon triple
Listed sites
1
Recruiting sites
—
Enrollment
205
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥28
Primary endpoint
•Body Weight
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 between 18 and 75 years, inclusive, of any gender;
2. Body mass index (BMI) ≥28.0 kg/m² or 24.0 kg/m² ≤ BMI < 28.0 kg/m² accompanied by at least one of the following: a. Prediabetes, hypertension, dyslipidemia, or fatty liver; b. Weight-bearing joint pain; c. Obesity-induced dyspnea or obstructive sleep apnea syndrome;
3. Stable body weight for 3 months prior to screening;
4. No fertility plans from screening to 6 months after study completion, willing to use contraceptive measures, and no sperm or egg donation plans within 6 months after study completion;
5. Fully informed about the study and voluntarily signed the written informed consent form.
Exclusion criteria
1. Known hypersensitivity to the investigational drug or its formulation excipients, or to other GLP-1 receptor agonist drugs, or a history of clinically significant multiple or severe drug allergies, or current allergic diseases, or high sensitivity constitution;
2. History of use of any of the following drugs or treatments within the specified periods prior to screening: 1) GLP-1 receptor agonists, GLP-1R/GCGR agonists, or GLP-1R/GIPR/GCGR agonists within 3 months before screening; 2) Over-the-counter weight-loss drugs or appetite suppressants within 3 months before screening, or prescription weight-loss drugs or lipolytic injectables within 3 months before screening; 3) Drugs likely to affect body weight (e.g.systemic glucocorticoids, tricyclic antidepressants, antipsychotics, or antiepileptics) for ≥2 consecutive weeks within 3 months before screening or expected during the trial; 4) Antidiabetic drugs (e.g.metformin, SGLT2 inhibitors,thiazolidinediones) within 3 months before screening;
3. History or evidence of any of the following diseases: 1) Diagnosis of type 1 diabetes, type 2 diabetes, or other types of diabetes; 2) History of acute or chronic pancreatitis or pancreatic surgery; 3) Symptomatic gallbladder disease within 2 years before screening (defined as imaging evidence of gallstones with doctor-diagnosed abdominal pain attributable to gallstones); subjects who have undergone cholecystectomy and/or cholelithiasis treatment without long-term complications may participate; 4) Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; 5) Secondary obesity due to disease or medication; 6) History of bariatric surgery (excluding: acupuncture for weight loss, liposuction, or abdominal liposuction performed >1 year before screening; gastric banding removed >1 year before screening; intragastric balloon removed >1 year before screening; duodenal-jejunal bypass sleeve removed >1 year before screening); 7) History of depression or Patient Health Questionnaire-9 (PHQ-9) score ≥15 at screening; or history of severe mental illness (including suicidal ideation/attempts, schizophrenia, bipolar disorder, etc.); 8) Clinically significant cardiovascular disease within 6 months before screening (defined as:
4. Screening abnormalities in any of the following tests: 1) HbA1c ≥6.5% or fasting blood glucose (FBG) ≥7.0 mmol/L; if FBG is 6.1-6.9 mmol/L at screening, an oral glucose tolerance test (OGTT) is required, and subjects with 2-hour post-load blood glucose ≥11.1 mmol/L will be excluded; 2) Hepatic or renal impairment (serum ALT and/or AST ≥3 times the upper limit of normal [ULN]; serum total bilirubin ≥1.5×ULN; estimated glomerular filtration rate [eGFR] <60 mL·min-¹·1.73m-² according to local laboratory reference ranges); 3) Serum calcitonin ≥50 pg/mL; 4) Thyroid dysfunction (confirmed by clinical assessment and/or abnormal thyroid-stimulating hormone [TSH]) with hyperthyroidism or hypothyroidism that may increase patient risk; 5) Fasting triglycerides ≥5.6 mmol/L; 6) Serum amylase or lipase >2.0×ULN; 7) International normalized ratio (INR) above the normal range at screening; 8) Hemoglobin <110 g/L (male) or <100 g/L (female); 9) Untreated or poorly controlled hypertension; 10) Clinically significant electrocardiogram (ECG) abnormalities at screening; 11) Diagnosis of hypokalemia or hypomagnesemia at screening; 12) Physical examination, vital signs, or laboratory findings with clinically significant abnormalities that, in the investigator's judgment, pose a major risk to the subject or interfere with safety, pharmacokinetic (PK), or pharmacodynamic (PD) result evaluation;
5. Positive hepatitis B surface antigen (HBsAg) with hepatitis B virus (HBV) deoxyribonucleic acid (DNA) above the reference value, positive hepatitis C virus (HCV) antibody with HCV ribonucleic acid (RNA) exceeding the reference range upper limit, positive human immunodeficiency virus (HIV) antibody, or positive syphilis antibody at screening;
6. Blood loss or blood donation exceeding 400 mL within 3 months before screening, or receipt of blood or blood component transfusions; or concurrent hemoglobinopathies, hemolytic anemia, or sickle cell anemia;
7. Participation in other clinical trials within 3 months before screening;
8. History of drug or alcohol abuse, defined as female subjects consuming >7 standard drinks per week or male subjects consuming >14 standard drinks per week;
9. Pregnant or lactating women;
10. Inability to tolerate venipuncture or history of fainting or dizziness during blood draws;
11. Other conditions deemed unsuitable for participation in the clinical trial by the investigator.
Endpoints (17)
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
3 endpointsBody Weight
Time frame:Week 24
descriptive
Waist Circumference
Time frame:Week 24
descriptive
BMI
Time frame:Week 24
descriptive
Glycemic / diabetes
1 endpointHbA1c
Time frame:Week 24
descriptive
Cardiometabolic biomarkers
4 endpointsFasting Serum Lipids
Time frame:Week 24
descriptive
Systolic blood pressure
Time frame:Week 24
descriptive
Diastolic blood pressure
Time frame:Week 24
descriptive
Pulse in beats per minute by investigator
Time frame:Through study completion, an average of six months
descriptive
Safety / tolerability / PK
4 endpointsAdverse Events
Time frame:Through study completion, an average of six months
descriptive
Plasma Concentration
Time frame:Through study completion, an average of six months
concentration, descriptive
ECG
Time frame:Through study completion, an average of six months
descriptive
Abnormal findings in physical examination by investigator
Time frame:Through study completion, an average of six months
descriptive
Other (unclassified)
5 endpointsMental Health Status
Time frame:Through study completion, an average of six months
categorical status, descriptive
Serum Anti-UBT251 Antibody Incidence
Time frame:Through study completion, an average of six months
descriptive
Titre and neutralizing antibody testing of antibody-positive samples
Time frame:Through study completion, an average of six months
descriptive
Respiration in breaths per minute by investigator
Time frame:Through study completion, an average of six months
ratio, improvement
Temperature in degree Celsius by thermometer
Time frame:Through study completion, an average of six months
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.