Obesity
Conditions
Interventions
Experimental group:Lxopaglutide a+ diet and exercise intervention
Control group:Placebo plus Diet and Exercise Intervention
Sponsors
Drum Tower Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1.Subjects must meet all of the following inclusion criteria to be eligible for this study: Male or female patients aged 18 to 55 years old (including the critical value, based on the time of signing the informed consent form); 2. Patients who have undergone metabolic surgery at the Affiliated Drum Tower Hospital of Nanjing University Medical School for 6 months; 3. During screening, the body mass index (BMI) should be greater than or equal to 28kg/m ². 4. Fertile subjects agreed to take the contraceptive measures stipulated in this protocol throughout the study and for 3 months after the last treatment. The pregnancy test results of female subjects with fertility must be negative during screening. Female subjects should not breastfeed throughout the study and within 3 months after the last treatment. 5. Voluntarily sign the informed consent form and be willing to strictly abide by the requirements and restrictions stipulated in the informed consent form and this protocol throughout the research period, including but not limited to: diet, exercise and lifestyle management, planned injection of research drugs, record-keeping of research diaries, and completion of relevant questionnaires, etc.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria are not eligible for this study: 1. Researchers suspect that the subjects may be allergic to the investigational drug or component or have an allergic constitution; 2. Use any of the following drugs or treatments before screening: Glucagon-like peptide-1 (GLP-1R) agonists were used within 3 months before screening Screening for drugs that have been used or are currently being used within the previous three months and have an impact on weight, including: Systemic steroid hormone drugs (intravenous, oral or intra-articular administration), metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, thiazolidinediones (TZD), tricyclic antidepressants, psychotropic drugs or sedatives (such as imipramine, amitriptyline, mirtazapine, paroxetine, phenylhydrazine) Chlorpromazine, thiodiazine, clozapine, olanzapine, valproic acid, valproic acid derivatives, lithium salts, etc. Those who have used Chinese herbal medicines, health supplements or meal replacements that affect weight within the three months prior to screening; Within the three months prior to the screening, weight loss drugs have been used or are currently being used, such as sibutramine hydrochloride, orlistat, butylamine, phenylpropanolamine, chlorphenimidole, fentamine, amphetamine, clocaserin, fentamine/topiramate mixture, naltrexone/bupropion mixture, etc. Have participated in other clinical trials (having received treatment with the trial drugs) within the three months prior to screening. 3. There is a history or evidence of any of the following diseases before screening: Has a history of depression in the past; Or there is a history of serious mental illness in the past, such as schizophrenia, bipolar disorder, etc. Hypertension that has not been stably controlled at the time of screening after at least 4 weeks of antihypertensive drug treatment is defined as: systolic blood pressure > 160mmHg and/or diastolic blood pressure > 100mmHg; Lie on your back and rest for at least 5 minutes. Then measure your blood pressure. If the blood pressure increases during the first measurement, measure it three times. Take the average of the three measurements to determine if the subject is qualified. There was a history of malignant tumors at the time of screening (except for cured basal cell carcinoma of the skin, squamous cell carcinoma of the skin and cervical carcinoma in situ); The following history of heart disease was present during the screening: Acute myocardial infarction, unstable angina pectoris, after coronary artery bypass grafting, after percutaneous coronary intervention (except diagnostic angiography), severe arrhythmias (such as ventricular fibrillation, ventricular flutter, atrial fibrillation, atrial flutter, grade II or III) (atrioventricular block, etc.) or pre-excitation syndrome, or a previous diagnosis of decompensated heart failure or grade III or IV heart failure as recognized by the New York Heart Association (NYHA); Hemorrhagic or ischemic stroke or transient ischemic attack occurred within 6 months before screening; When screening, there was a history of medullary thyroid carcinoma, multiple endocrine adenomatosis (MEN) 2A or 2B, or a family history. There was a history of acute or chronic pancreatitis and pancreatic injury during the screening process. There are limb deformities or deficiencies, making it impossible to accurately determine indicators such as height and weight. Those who had undergone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| %TWL (Total Weight Loss Percentage); | — |
Secondary
| Measure | Time frame |
|---|---|
| Biochemistry;Glycated Hemoglobin;Insulin resistance index;Nutritional indicators; | — |
Countries
China
Contacts
Public ContactWenhuan Feng
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School of Nanjing University
Outcome results
None listed