overweight/obesity
Conditions
Interventions
1:Beinaglutide
2:placebo
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Voluntarily signed the informed consent form; 2 Male or female aged 18-70 years (inclusive) at screening; 3 BMI at screening meets the following requirements (comply with a or b): 1) BMI=28.0 kg/m2; 2) BMI = 24.0 kg/m2 with at least one of the following: ? Exuberant appetite, unbearable hunger before the meal, more food intake each meal; ? Combined with one or several of hyperglycemia, hypertension, dyslipidemia and fatty liver; ? Combined with weight-bearing joint pain; ? Obesity causes dyspnea or obstructive sleep apnea syndrome.
Exclusion criteria
Exclusion criteria: 1 Patients with definitely diagnosed type 1 diabetes or type 2 diabetes; 2 Fasting venous glucose = 7.0 mmol/L or venous glucose = 11.1 mmol/L two hours after a 75 g oral glucose tolerance test (OGTT) glucose load; 3 Patients who complain of weight change > 5% within 3 months before screening; 4 Use of weight-loss drugs or glucagon-like (GLP-1) drugs within 3 months prior to screening; 5 Use of drugs that may cause significant weight gain within 3 months prior to screening: including systemic glucocorticoid therapy lasting more than 1 week (excluding topical and inhaled preparations); tricyclic antidepressants; antipsychotics or antidepressants (imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine hydrochloride, clozapine, olanzapine, valeric acid and its derivatives, lithium, thioridazine, etc.); 6 History or family history of multiple endocrine neoplasia type 2; 7 History or family history of medullary thyroid cancer; 8 History of acute or chronic pancreatitis; 9 History of weight loss surgery; 10 Obesity due to other endocrine diseases, such as Cushing's syndrome, hypothyroidism, polycystic ovary disease or other genetic endocrine diseases; 11 Have a clear history of mental illness, such as depression, schizophrenia, bipolar disorder; 12 Definite gastrointestinal motility disorders or obstructive diseases, such as gastroparesis and gastroesophageal reflux disease; 13 Have a clear history of cancer; 14 Previous history of serious heart disease with one of the following conditions: 1) Diagnosed with decompensated cardiac insufficiency (New York Heart Association [NYHA] Class III- IV); 2) Unstable angina pectoris; 3) Diagnosed with myocardial infarction; 15 Untreated or poorly controlled hypertension (systolic blood pressure = 160 mmHg and/or diastolic blood pressure = 100 mmHg); 16 Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin = 3 times the upper limit of normal (ULN) at screening; 17 Amylase or lipase = 3 × ULN at screening; 18 Renal impairment, defined as serum creatinine level = 1.5 mg/dL (132 µmol/L) for men or = 1.4 mg/dL (123 µmol/L) for women at screening; 19 Severe Lipodystrophy: triglycerides (TG = 500 mg/dL (5.7 mmol/L) at screening; 20 PHQ-9 questionnaire = 15 points; 21 Received any investigational drug within 3 months prior to screening; 22 Hospitalization or surgery within 30 days prior to screening, or elective hospitalization or surgery planned at screening and elective hospitalization or surgery within the period of estimated participation in this trial; 23 History of drug abuse within 6 months and/or alcohol abuse within 6 months prior to screening; 24 Patients who are allergic to the investigational drug and any components, or other GLP-1 drugs; 25 Pregnant or lactating women; 26 Male and female subjects who cannot take effective contraceptive measures during the trial; 27 Those considered unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference from placebo in mean percentage of subjects' weight loss from baseline at Week 16;Comparison of the proportion of subjects with at least a 5% reduction in body weight from baseline between the treatment and placebo groups at 16 weeks.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent body weight loss from baseline at 28 weeks;Change from baseline in body weight at 16 and 28 weeks;Change from baseline in waist circumference at 16 weeks and 28 weeks;Change from baseline in waist-to-hip ratio at 16 weeks and 28 weeks;Change from baseline in blood pressure at 16 and 28 weeks;Change from baseline in lipids at 16 and 28 weeks;Change from baseline in blood glucose at 16 and 28 weeks;Change from baseline in insulin at 16 and 28 weeks;AE during the 28 weeks’ treatment;physical examination at 16 and 28 weeks;Laboratory safety variables at 4, 16, 28 weeks;Beinaglutide antibody at 16 weeks;ECG at 16 and 28 weeks;Mental status score (PHQ-9 scale) at 4, 16, 28 weeks; | — |
Countries
China
Contacts
Public ContactYiming Mu
Outcome results
None listed