A Phase 4 interventional study of Efsubaglutide Alfa Injection and Diet and exercise guidelines in Obesity, Weight Loss and Metabolic Surgery, sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Phase 4, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School is the lead sponsor of 242 studies on the registry; 144 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects suspected by the investigator of having a potential allergy to the study drug or its components, or those with a history of allergic constitution;
Use of any of the following drugs or treatments prior to screening:
● Glucagon-like peptide-1 (GLP-1R) agonists within 3 months prior to screening
● Use within 3 months prior to screening of any weight-affecting medications, including systemic corticosteroids, metformin, sodium-glucose cotransporter 2 (SGLT2) inhibitors, etc.;
● Use of weight-affecting herbal supplements, health products, or meal replacements within 3 months prior to screening;
Participation in other clinical trials (receiving investigational drug treatment) within 3 months prior to screening.
③ History or evidence of any of the following conditions prior to screening:
History of alcohol abuse within 1 month prior to screening, defined as average weekly alcohol intake exceeding 21 units for males or 14 units for females; ④ Presents clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening: - Second- or third-degree atrioventricular block - Long QT syndrome or QTcF > 450 ms - PR interval \< 120 ms or PR interval > 220 ms - QRS > 120 ms QRS duration >120ms, left or right bundle branch block, Wolff-Parkinson-White syndrome, or other severe arrhythmias requiring treatment;
Receive guidance on diet and exercise throughout the program, started pharmacological intervention at enrollment for 24 weeks.
Drug: Efsubaglutide Alfa Injection · Behavioral: Diet and exercise guidelines
Receive guidance on diet and exercise throughout the program, without the use of drugs.
Behavioral: Diet and exercise guidelines
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.
Also known as: Drug injection
Participants followed a science-based diet and exercise program intervention.
Also known as: Lifestyle guidelines
Change 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.
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
Plan to share: No — No participant data are available
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School