Obesity, Weight Control
Conditions
Keywords
obesity, GLP-1 RA, Exercise, Nutrition, Sustained weight Control
Brief summary
Obesity is a chronic, progressive, and relapsing disease. Although lifestyle interventions and anti-obesity medications are effective for inducing weight loss, evidence regarding their role in long-term weight maintenance after pharmacologically induced weight reduction remains limited. In addition, the high cost and potential adverse effects of weight-loss medications restrict their prolonged use, and it is unclear whether low dose medication, intensive life style intervention or together can serve as an effective strategy for weight maintenance. This randomized controlled trial aims to evaluate the effectiveness of a 1-year intensive lifestyle intervention, a reduced dose of mazdutide (3.0 mg once weekly), or their combination in weight maintenance among individuals with obesity who have achieved initial weight loss after intensive treatment with high dose mazdutide. The study seeks to provide high-quality clinical evidence to inform long-term weight maintenance strategies after weight loss in patients with obesity.
Interventions
DRUGMazdutide
Mazdutide is administered subcutaneously at 3.0 mg once weekly for 52 weeks during the weight maintenance period.
BEHAVIORALIntensive Lifestyle Intervention
A structured intensive lifestyle intervention including individualized dietary counseling, physical activity guidance, and behavioral modification support for 52 weeks during the weight maintenance period.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult men or women aged 18 years or older; * Simple obesity, defined as a body mass index (BMI) of 28.0-45.0 kg/m²; * Able and willing to provide written informed consent.
Exclusion criteria
* Active pulmonary tuberculosis, malignant tumors, human immunodeficiency virus (HIV) infection, or other serious infectious or systemic diseases; * Severe hepatic impairment (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \>3 times the upper limit of normal), severe renal impairment, or end-stage renal disease (estimated glomerular filtration rate \[eGFR\] \<30 mL/min/1.73 m²); * Severe cardiovascular diseases, including angina pectoris, myocardial infarction, or stroke within the past 6 months; * Severe gastrointestinal diseases, or a history of gastrointestinal resection surgery within the past year; * Acute or chronic pancreatitis, gallbladder disease, or pancreatic injury; * Obesity secondary to other causes, including Cushing's syndrome, primary hypothyroidism, hypothalamic obesity, or acromegaly; drug-induced obesity, such as obesity related to the use of antipsychotic agents or glucocorticoids; * Current smoker or habitual smoking within the past 3 months; * Current use of other weight-loss medications or a history of bariatric surgery; * Previously diagnosed diabetes mellitus or current use of glucose-lowering medications; * Pregnant or breastfeeding women, or women planning pregnancy during the study period; * Inability to complete a 2-year follow-up due to health conditions, relocation, or other reasons; * Any other condition deemed by the investigator to make the participant unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change of body weight | From randomization to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in body mass index (BMI) | From randomization to Week 52 | — |
| Change in waist circumference | From randomization to Week 52 | — |
| Change in total body fat | From randomization to Week 52 | — |
| Change in abdominal visceral fat area | From randomization to Week 52 | Abdominal visceral fat area is quantified by CT scan |
| Change in hepatic fat content | From randomization to Week 52 | Hepatic fat content is quantified by controlled attenuation parameter (CAP), measured by Fibroscan. |
| Change in blood pressure | From randomization to Week 52 | — |
| Change in serum lipid profile | From randomization to Week 52 | — |
| Changes in blood glucose | From randomization to Week 52 | — |
| Changes in insulin sensitivity | From randomization to Week 52 | Insulin sensitivity is assessed by HOMA-IR index |
| Changes in pancreatic β-cell function | From randomization to Week 52 | Pancreatic β-cell function is assessed by HOMA-β index |
| Change in pulse wave velocity (PWV) | From randomization to Week 52 | — |
| Quality of sleep measured by the Pittsburgh sleep quality index (PSQI) | From randomization to Week 52 | — |
| Quality of life measured by the 12-item Short-Form Health Survey Questionnaire (SF-12) | From randomization to Week 52 | — |
Countries
China
Contacts
CONTACTJINGJING JIANG, MD, PhD
Outcome results
None listed