Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-55
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
6 months after metabolic surgery
18 years ≤ age ≤ 55 years
Body Mass Index (BMI) ≥ 28 kg/m²
Voluntarily sign the informed consent form and agree to strictly adhere to the requirements and restrictions outlined in the informed consent form and this protocol throughout the entire study period.
Disqualifiers
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 weight-loss medications within 3 months prior to screening or currently using such medications, e.g., sibutramine hydrochloride, orlistat, phentermine, etc.;
Participation in other clinical trials (receiving investigational drug treatment) within 3 months prior to screening.
History of depression; or history of severe psychiatric disorders such as schizophrenia, bipolar disorder, etc.;
Trial design
Design model
Parallel
Treatments tested in this trial
Efsubaglutide Alfa Injection
DrugEfsubaglutide 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.
Diet and exercise guidelines
BehavioralParticipants followed a science-based diet and exercise program intervention.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Efsubaglutide Alfa groupExperimental treatment 2 interventions
Group B: control groupSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 enrollmentSecondary outcomes
1
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 enrollment2
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 enrollment3
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 enrollment4
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 enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov