overweight/obese
Conditions
Interventions
A1:Abdominal subcutaneous injection of 1 mg UBT251 Injection or placebo, once weekly for 12 weeks (10 investigational drug and 2 placebo cases)
A4:Abdominal subcutaneous injection: UBT251 (1 mg qw × 4 weeks
3 mg qw × 4weeks
6 mg qw × 4weeks
9mg qw × 4weeks) or placebo (10 drug, 2 placebo cases)
A2:Abdominal subcutaneous injection of UBT251 Injection (1 mg qw × 4 weeks
3 mg qw × 8 weeks) or placebo (10 investigational drug, 2 placebo cases)
A3:Abdominal subcutaneous injection: UBT251 (1 mg qw × 4 weeks
6 mg qw × 4weeks) or placebo (10 drug, 2 placebo cases)
A5:Abdominal subcutaneous injection:UBT251 (0.5mg qw × 4 weeks
1 mg qw × 4weeks
6mg qw × 4weeks) or placebo (10 drug, 2 placebo cases)
Sponsors
The Third Xiangya Hospital Central South University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. At the time of signing the informed consent, subjects must be aged >= 18 years and = 28.0 kg/m^2; or overweight subjects: BMI between 24.0 kg/m^2 and < 28.0 kg/m^2 with at least one of the following conditions: (1) One or more of prediabetes (impaired fasting glucose and/or impaired glucose tolerance; see Appendix 1 for reference criteria), hypertension, dyslipidemia (see Appendix 2 for reference criteria), or fatty liver (either during screening or within 6 months prior to screening); (2) Weight-bearing joint pain (either during screening or within 6 months prior to screening); (3) Dyspnea caused by obesity or obstructive sleep apnea syndrome (either during screening or within 6 months prior to screening); 3.Body weight has remained stable for 3 months prior to randomization (weight change < 5%); 4. Subjects (including their partners) must have no childbearing plans from screening until 6 months after the completion of the trial, agree to use contraceptive measures, and have no plans to donate sperm or eggs within 6 months after the trial completion; 5. Have a full understanding of the study, voluntarily participate in it, and have signed a written informed consent form; 6. Subjects must be able to communicate effectively with investigators and understand and comply with all requirements of the study.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to this drug or its preparation excipients, or allergic to other GLP-1 receptor agonists, or have a history of clinically significant multiple or severe drug allergies, or have current allergic diseases or high allergies; 2. Previous use of any of the following drugs or treatments: (1) Use of GLP-1 receptor agonists (GLP-1R) or GLP-1R/GCGR agonists or GLP-1R/GIPR/GCGR agonists within 3 months prior to screening; (2) Use of over-the-counter weight loss drugs or food inhibitors (including traditional Chinese medicine) within 1 month before screening, or use of weight loss prescription drugs (including but not limited to orlistat, phentermine, marindole) or lipid-dissolving injections (e.g., fat dissolving injections) within 3 months before screening; (3) Use of drugs that may affect body weight within 3 months prior to screening or for 2 weeks or more in anticipated trials, including but not limited to systemic glucocorticoid therapy, metformin, tricyclic antidepressants, antipsychotics or antiepileptic drugs (e.g., mipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valeric acid and its derivatives, lithium preparations, methionadazine); (4) Continuous use of central nervous system stimulants (such as methylphenidate hydrochloride) at screening, except caffeinated beverages; (5) Those who have received live attenuated vaccines or new crown vaccines within 1 month before screening, or plan to be vaccinated during the trial. 3. History or evidence of any of the following diseases: (1) Diagnosed with type 1, type 2 diabetes, gestational diabetes or other types of diabetes; (2) Acute pancreatitis within 6 months before screening or previous history of chronic pancreatitis and pancreatic surgery; (3) Obvious clinical signs or symptoms of liver disease, acute and chronic hepatitis; (4) Those with a personal history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2) (within first-degree relatives, i.e., parents, children or siblings); (5) obesity caused by secondary diseases or drugs, including: elevated cortisol hormones (such as Cushing's syndrome), obesity due to pituitary and hypothalamic damage, obesity due to tapering/discontinuation of diet medications; (6) History of bariatric surgery, except for the following: (1) Liposuction and/or abdominoplasty > 1 year prior to screening; (2) use a gastric brace but removed > 1 year prior to screening; (3) Use of intragastric balloon, but the balloon is removed > 1 year prior to screening; (4) Duodeno-jejunal bypass cannula if the cannula was removed > 1 year prior to screening; (7) Previous history of depression or Health Questionnaire Depression Rating Scale (PHQ-9) score >=15 points at screening; or have a history of severe mental illness, including but not limited to suicidal tendencies or suicide attempts, schizophrenia, bipolar disorder, etc.; (8) Patients with clinically significant, active cardiovascular and cerebrovascular disease within 6 months prior to screening, defined as: i. Myocardial infarction (MI) or unstable angina; ii Heart-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention); iii Congestive heart failure (New York College of Cardiology [NYHA] class III-IV); iv cerebrovascular accident (other than old lacunar cerebral infarction), including but not limited to stroke/transient ischemic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event;12-lead ECG data; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics;Four Lipid Profiles (Triglycerides, Total Cholesterol, Low-Density Lipoprotein Cholesterol, High-Density Lipoprotein Cholesterol);Body Weight;Immunogenicity; | — |
Countries
China
Contacts
Public ContactGuoping Yang
The Third Xiangya Hospital Central South University
Outcome results
None listed