This clinical trial aims to evaluate the weight-loss efficacy and safety of efsubaglutide alfa in patients who remain obese 6 months after metabolic surgery.
This study investigates the effects of efsubaglutide alfa intervention in patients with a body mass index (BMI) ≥28 kg/m² six months after metabolic surgery, aiming to determine whether it facilitates weight normalization and remission of obesity-related comorbidities, thereby assessing the weight-loss and metabolic benefits of early efsubaglutide alfa application in post-metabolic surgery obesity management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Efsubaglutide Alfa was injected daily in the morning before meals Subcutaneous injection at a dose of 1 mg/week in the first two weeks, increased to 3 mg/week in week 3, increased to 6 mg/week in week 5, up to 9 mg/2 week in week 13.
Participants followed a science-based diet and exercise program intervention.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
RECRUITINGChange in %TWL from baseline to endpoint
%TWL = (\[baseline weight - weight at follow-up\]/baseline weight) × 100%. The measurement of body weight is in kilograms. %TWL represents the percentage of total weight loss, measured in percent. This indicator reflects the percentage of weight loss from the baseline. The mean and standard deviation of %TWL were calculated for subjects within each group. Subsequently, intergroup comparisons were performed to calculate p-values. If p \< 0.05, pairwise comparisons were further conducted. Based on the final results, the differences in weight loss among groups were evaluated.
Time frame: 24 weeks from enrollment
Proportion of patients with different %TWL levels
%TWL = (\[baseline weight - weight at follow-up\]/baseline weight) × 100%. The measurement of body weight is in kilograms. %TWL represents the percentage of total weight loss, measured in percent. This indicator reflects the proportion of patients achieving clinically meaningful %TWL thresholds (≥ 5%, ≥ 10%, ≥ 15%, and ≥ 20%). Then perform intergroup comparison to calculate the p-value and assess the weight loss difference between the two groups.
Time frame: 24 weeks from enrollment
Proportion of patients with normal weight and overweight
BMI = Weight / Height\^2 Weight is measured in kilograms, height in meters, and BMI is expressed in kilograms per square meter. This indicator reflects percentage of patients with normal weight (BMI\<24kg/m2) and overweight (BMI \<28kg/m2) from baseline after intervention. Then perform intergroup comparison to calculate the p-value and assess the difference between the two groups.
Time frame: 24 weeks from enrollment
Change in body composition from baseline to endpoint across patient groups
Body composition (Including body fat, fat-free mass, skeletal muscle, etc.; in kilograms) Body composition values at the endpoint minus baseline values are used as the change metric to evaluate body composition changes (These indicators are used to assess the body composition improvement of patients) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons.
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Time frame: 24 weeks from enrollment
Remission Status of Obesity-Related Diseases
Obesity-Related Diseases include: Diabetes Mellitus, Hypertension, Fatty Liver Disease, Hyperlipidemia and Hyperuricemia. Remission status was assessed based on the incidence of complications in patients at baseline and endpoint. Then perform intergroup comparison to calculate the p-value and assess the differences in disease remission between the two groups.
Time frame: 24 weeks from enrollment
Changes in blood pressure from baseline to endpoint
Difference between the endpoint blood pressure and the baseline value.(blood pressure in mmHg; This indicator is used to assess improvements in a patient's blood pressure.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons.
Time frame: 24 weeks from enrollment
Changes in fasting blood glucose from baseline to endpoint
Difference between endpoint fasting blood glucose and baseline value (blood glucose in mmol/L; This indicator is used to assess improvements in patients' fasting blood glucose levels.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons.
Time frame: 24 weeks from enrollment
Change in HbA1c from baseline to endpoint across patient groups
Difference between the endpoint HbA1c value and the baseline value (HbA1c in percentage, This indicator is used to assess improvements in a patient's HbA1c levels.) Complete data correction for each patient using baseline values, then calculate overall mean and SD by group. Subsequently perform intergroup comparisons to compute P-values; if P \< 0.05, proceed with pairwise comparisons.
Time frame: 24 weeks from enrollment