Obesity
Conditions
Interventions
Protein podwer intervention:Based on the recommended protein intake calculated in accordance with clinical guidelines, 18g of whey protein (equivalent to 22.5g of protein powder)
Standard dietary group:Standard high-protein dietary guidance in accordance with clinical guidelines
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years, inclusive, regardless of gender; 2.Body Mass Index (BMI) >=28kg/m^2, or BMI >= 24 kg/m^2 with at least one weight-related comorbidity, such as hyperglycemia, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease; 3.A change in body weight of less than 5% in the 90 days prior to screening through diet and exercise management alone; 4.Voluntarily agrees to participate and provides written informed consent.
Exclusion criteria
Exclusion criteria: 1.HbA1c > 6.5% or fasting venous plasma glucose > 7.0 mmol/L at screening; or a diagnosis of type 1 diabetes mellitus, type 2 diabetes mellitus, or other specific types of diabetes; 2.Previous bariatric or metabolic surgery (except liposuction, abdominoplasty, or removal of an intragastric balloon or duodenal-jejunal bypass sleeve > 1 year prior to screening); or planned to undergo any bariatric surgery during the trial period; 3.Obesity or weight gain secondary to medication use, Cushing's syndrome, acromegaly, edema, or other identifiable causes; 4.Known or suspected allergy to mazdutide or any of its excipients; 5.Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 prior to screening; or diagnosis of any malignancy within 5 years; 6.Presence of severe gastrointestinal disorders, such as gastric emptying disorders or inflammatory bowel disease; 7.Moderate to severe depression, with a total score > 15 on the Patient Health Questionnaire-9 (PHQ-9) at screening; diagnosis of other severe psychiatric disorders, including schizophrenia or bipolar disorder; history of suicidal ideation, suicide attempt, or suicidal behavior; 8.Presence of chronic pancreatitis, acute pancreatitis, or symptomatic gallbladder disease (except following cholecystectomy); 9.History of substance abuse, drug addiction, or alcohol dependence; 10.Female subjects of childbearing potential who are pregnant or lactating at screening, or have a positive serum human chorionic gonadotropin (hCG) test 11.Use of implantable electronic devices, such as an implantable cardioverter-defibrillator or cardiac pacemaker; 12.Inability to use a mobile phone or lack of reading and recording ability; inability to comply with follow-up visits or to provide signed informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| body weight (kg) and skeleton muscle mass (kg); | — |
Secondary
| Measure | Time frame |
|---|---|
| Resting Energy Expenditure (REE);Dietary nutrition intake; | — |
Countries
China
Contacts
Public ContactTian Fang
Huashan Hospital, Fudan University
Outcome results
None listed