Obesity
Conditions
Interventions
Tirzepatide 5mg treatment group:A starting dose of 2.5 mg was administered subcutaneously once weekly, increasing by 2.5 mg every 4 weeks until a maintenance dose of 5 mg was reached at week 5, total
Tirzepatide 10mg treatment group:A starting dose of 2.5 mg was administered subcutaneously once weekly, increasing by 2.5 mg every 4 weeks until a maintenance dose of 10 mg was reached at week 13, tot
metformin treatment group:Started at 1000 mg/day (500 mg twice daily, orally) and increased to 2000 mg/day (1000 mg twice daily, orally) after 2 weeks for a total of 48 weeks.
Sponsors
Shanghai Sixth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.18 to 65 years of age (inclusive of 18 and 65 years) at the time of signing the informed consent form (ICD); 2.Severe obese patients with BMI >=32.5kg/m^2 before metabolic surgery who have undergone metabolic surgery (SG or RYGB, etc.); 3.Meet the criteria for regaining weight after metabolic surgery %MWL >=20%; 4.Willing and able to comply with the study process as defined by the protocol; 5.Able to understand and sign the study informed consent form, and if illiterate, willing to put their handprints on the informed consent form.
Exclusion criteria
Exclusion criteria: 1.%MWL = 5.7 mmol/L, previous history of acute pancreatitis; medullary thyroid carcinoma or multiple endocrine adenomas or family history; 5.History of drug and/or alcohol abuse within 2 years prior to the screening visit; psychiatric disorders that may interfere with clinical study compliance, including dementia, active psychosis, major depression, or attempted suicide; 6. Any of the following conditions are met a.Inflammatory diseases of the gastrointestinal tract, including severe intractable esophagitis, gastric ulcers, duodenal ulcers, or atopic inflammatory diseases that have been active for the past 10 years, such as Crohn's disease or ulcerative colitis; b.Renal insufficiency with a glomerular filtration rate <45 ml/min/1.73 m^2; c.Hepatic insufficiency, with alanine aminotransferase greater than three times the upper limit of normal and total bilirubin greater than two times the upper limit of normal; d.Immunocompromised, e.g., by prolonged oral steroid hormone use, cancer chemotherapeutic agents, or immunodeficiency disorders; e. Type1 diabetes mellitus or specific type of diabetes mellitus. 7.Participation in any other clinical study (other than an enrollment or investigational study) within 30 days prior to Visit 1 (Screening Visit) or during the course of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight loss from baseline after 48 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin (HbA1c) ;Low density lipoprotein (LDL) cholesterol;Triglyceride;High density lipoprotein (LDL) cholesterol;Systolic blood pressure;Diastolic blood pressure;Waist circumstance;Hip circumstance;Height;Glycated albumin;Fasting plasma glucose;Fasting insulin;fasting C peptide;Total cholesterol;Metabolic syndrome; | — |
Countries
China
Contacts
Public ContactTu Yinfang
Shanghai Sixth People's Hospital
Outcome results
None listed