Obesity &Amp; Overweight
Conditions
Brief summary
This randomized, double-blind, parallel, placebo-controlled phase II study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients
Interventions
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
Sponsors
The United Bio-Technology (Hengqin) Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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: i. Myocardial infarction or unstable angina; ii. Cardiac surgery; iii. Congestive heart failure; iv. Cerebrovascular accident, including stroke/transient ischemic attack; v. Other cardiovascular diseases deemed unsuitable for the trial by the investigator); 9) History of retinal disease; 10) History of severe hypoglycemia or recurrent symptomatic hypoglycemia; 11) Concurrent gastroparesis or other gastrointestinal motility disorders, uncontrolled gastroesophageal reflux disease, or gastrointestinal diseases that increase the risk of adverse events with medication use; 12) Major surgery, severe trauma, or severe infection within 1 month before screening, as judged by the investigator to be unsuitable for the trial; 13) History of malignant tumors; 14) Limb deformities or disabilities that prevent accurate measurement of height, weight, or other indicators; 15) Concurrent diseases (e.g.neurological, endocrine, mental diseases) that, in the investigator's opinion, may affect subject safety, efficacy evaluation, or compliance; 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Week 24 | Percentage change in body weight from baseline after 24 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | Week 24 | change in waist circumference from baseline after 24 weeks of treatment |
| BMI | Week 24 | change in BMI from baseline after 24 weeks of treatment |
| Fasting Serum Lipids | Week 24 | change in fasting serum lipids from baseline after 24 weeks of treatment |
| Systolic blood pressure | Week 24 | change in systolic blood pressure from baseline after 24 weeks of treatment |
| Diastolic blood pressure | Week 24 | change in diastolic blood pressure from baseline after 24 weeks of treatment |
| HbA1c | Week 24 | change in HbA1c from baseline after 24 weeks of treatment |
| Adverse Events | Through study completion, an average of six months | The incidence of Adverse Event (AE), Adverse Event of Special Interest (AESI), Adverse Drug Reaction (ADR), Serious Adverse Event (SAE) and withdrawal due to Adverse Events |
| Mental Health Status | Through study completion, an average of six months | Changes in mental health status which will be evaluated using the PHQ-9 scale |
| Plasma Concentration | Through study completion, an average of six months | Plasma Concentration of UBT251 at different time point |
| Serum Anti-UBT251 Antibody Incidence | Through study completion, an average of six months | Change in serum anti-UBT251 antibody incidence |
| Titre and neutralizing antibody testing of antibody-positive samples | Through study completion, an average of six months | change in titre and neutralizing antibody testing of antibody-positive samples |
| ECG | Through study completion, an average of six months | change in components of the ECG (e.g. QRS Complex, QT Interval, etc.) |
| Respiration in breaths per minute by investigator | Through study completion, an average of six months | change in respiration in breaths per minute by investigator |
| Temperature in degree Celsius by thermometer | Through study completion, an average of six months | change in temperature in degree Celsius by thermometer |
| Pulse in beats per minute by investigator | Through study completion, an average of six months | change in pulse in beats per minute as measured by the investigator |
| Abnormal findings in physical examination by investigator | Through study completion, an average of six months | change in physical examination by investigator which includes the skin, lymph nodes, head, neck, heart, lungs, abdomen, umbilical region, and spine/limbs. Abnormal findings from the physical examination will be recorded. |
Countries
China
Outcome results
None listed