Obesity & Overweight
Conditions
Brief summary
This randomized, double-blind, parallel, placebo-controlled phase Ⅲ study to evaluate the efficacy and safety of UBT251 Injection in overweight/obese patients
Interventions
UBT251 Injection subcutaneously once weekly
UBT251 Injection and UBT251 Injection Placebo subcutaneously once weekly
UBT251 Injection placebo subcutaneously once weekly
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
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
： 1. Age 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender; 2. Body mass index (BMI) ≥28.0 kg/m² (obesity) or 24.0 kg/m² ≤ BMI \<28.0 kg/m² (overweight) at screening, accompanied by 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. Self-reported having been on diet and exercise control for 3 months or more prior to screening, with body weight change ≤5 kg within the past 3 months; 4. Trial participants (including their partners) have no plan for pregnancy from screening to 6 months after trial completion, and are willing to comply with the contraceptive measures specified in the trial, and have no plan for sperm or egg donation within 6 months after trial completion; 5. Have been fully informed about this study and voluntarily sign a written informed consent form.
Exclusion criteria
1. Known history of hypersensitivity to this study drug, its drug product excipients, or other similar active drugs; 2. Any of the following medication history within 3 months before randomization: 1. Treatment with dipeptidyl peptidase-4 (DPP-4) inhibitors, amylin analogs, glucagon-like peptide-1 (GLP-1) analogs, glucose-dependent insulinotropic polypeptide (GIP) analogs, or glucagon (GCG) analogs; 2. Use of over-the-counter weight-loss medications or appetite suppressants (including traditional Chinese medicine, dietary supplements, meal replacements), or prescription weight-loss medications (including but not limited to orlistat) or lipolytic injections (e.g., fat-dissolving injections); 3. Use of medications that may affect body weight for a duration of 1 week or longer, or anticipated use during the trial, including but not limited to systemic glucocorticoid therapy (intravenous or oral administration, except for the following: topical external use or intra-articular, intranasal, ophthalmic, and inhaled glucocorticoids; short-term \[≤7 days\] systemic glucocorticoid use for prevention or treatment of non-autoimmune allergic diseases, upper respiratory tract infection); 4. Treatment with tricyclic antidepressants, antipsychotics, or antiepileptic medications; 5. Treatment with antidiabetic medications; 3. History or evidence of any of the following diseases: 1. Diagnosis of type 1, type 2 diabetes mellitus, or other types of diabetes mellitus (excluding history of gestational diabetes mellitus); 2. Secondary obesity caused by diseases (including but not limited to elevated cortisol hormones \[e.g., Cushing's syndrome\], pituitary/hypothalamic injury, hypothyroidism, etc.) or medications (including but not limited to long-term glucocorticoid use, antidepressants, etc.); 3. History of acute or chronic pancreatitis, or pancreatic surgery; 4. History of symptomatic gallbladder disease within 1 year before screening (excluding trial participants who have undergone cholecystectomy \[completed at least 3 months before screening\] without long-term complications), or abdominal ultrasound at screening indicating large gallstones (diameter ≥2 cm), gallbladder polyps (diameter ≥1 cm), or other gallbladder lesions that the study physician determines may affect trial participant safety; 5. Personal or family history (within first-degree relatives, i.e., parents, children, or siblings) of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); 6. Planned bariatric surgery during the trial or history of bariatric surgery, except for the following: a) acupuncture for weight loss or liposuction (e.g., abdominal liposuction) performed \>1 year before screening; b) gastric banding, but the band was removed \>1 year before screening; c) intragastric balloon, but the balloon was removed \>1 year before screening; d) duodenal-jejunal bypass liner, but the liner was removed \>1 year before screening; 7. History of depression or severe mental illness (including but not limited to suicidal tendencies, schizophrenia, bipolar disorder, etc.); 8. History of clinically significant cardiovascular or cerebrovascular disease within 6 months before screening; 9. Severe retinal or macular disease (including but not limited to proliferative retinopathy, macular edema, retinal detachment, etc.) at screening or in the past, requiring urgent treatment as determined by the study physician; 10. History of malignancy; 4. Blood loss ≥400 mL (including trauma, blood draw, blood donation) within 3 months before screening, or receipt of blood or blood component transfusion; 5. Lactating women or pregnant women;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Weight | Week 52 | Percentage change in body weight from baseline after 52 weeks of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Waist Circumference | Through study completion, an average of one year | Changes from baseline in waist circumference at each visit |
| BMI | Through study completion, an average of one year | Changes from baseline in BMI at each visit |
| Systolic blood pressure | Through study completion, an average of one year | Changes from baseline in systolic blood pressure at each visit |
| Diastolic blood pressure | Through study completion, an average of one year | Changes from baseline in diastolic blood pressure at each visit |
| HbA1c | Week 12 、Week 24、Week 32、Week 52 | change in HbA1c from baseline after 12 weeks 、24 weeks 、32 week、52 weeks of treatment |
| Fasting Serum Lipids | Week 12 、Week 24、Week 32、Week 52 | change in fasting serum lipids from baseline after 12 weeks 、24 weeks 、32 week、52 weeks of treatment |
| SF-36 v2 scores | Week 12 、Week 24、Week 32、Week 52 | Changes from baseline in SF-36 v2 scores at Weeks 12, 24, 32, and 52 |
| Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) scores | Week 12 、Week 24、Week 32、Week 52 | Changes from baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) scores at Weeks 12, 24, 32, and 52 |
Countries
China
Contacts
CONTACTWeilong Tao
Outcome results
None listed