Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery

NCT07163650 | Recruiting Phase 4

• 1 other identifier: 2025-0631-01
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Weight Loss; Metabolic Surgery

Keywords

obesity; BMI; GLP-1 receptor agonist; Efsubaglutide Alfa; Metabolic surgery

Outcome Measures

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.

  24 weeks from enrollment

Secondary Outcomes (7)

• Proportion of patients with different %TWL levels

  24 weeks from enrollment

• Proportion of patients with normal weight and overweight

  24 weeks from enrollment

• Change in body composition from baseline to endpoint across patient groups

  24 weeks from enrollment

• Remission Status of Obesity-Related Diseases

  24 weeks from enrollment

• Changes in blood pressure from baseline to endpoint

  24 weeks from enrollment

Study Arms (2)

Efsubaglutide Alfa group

EXPERIMENTAL

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

control group

SHAM COMPARATOR

Receive guidance on diet and exercise throughout the program, without the use of drugs.

Behavioral: Diet and exercise guidelines

Interventions

Efsubaglutide Alfa Injection DRUG

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

Efsubaglutide Alfa group

Diet and exercise guidelines BEHAVIORAL

Participants followed a science-based diet and exercise program intervention.

Also known as: Lifestyle guidelines

Efsubaglutide Alfa group; control group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• months after metabolic surgery
• years ≤ age ≤ 55 years
• Body Mass Index (BMI) ≥ 28 kg/m\^2
• 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.

You may not qualify if:

• 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;
• 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.
• ③ History or evidence of any of the following conditions prior to screening:
• History of depression; or history of severe psychiatric disorders such as schizophrenia, bipolar disorder, etc.;
• Uncontrolled hypertension at screening despite at least 4 weeks of antihypertensive medication, defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg;
• History of malignancy at screening;
• History of cardiac disease at screening: acute myocardial infarction, unstable angina, post-coronary artery bypass grafting, post-percutaneous coronary intervention, severe arrhythmia;
• Hemorrhagic or ischemic stroke, or transient ischemic attack within 6 months prior to screening;
• History or family history of medullary thyroid carcinoma, multiple endocrine neoplasia (MEN) type 2A or 2B at screening;
• History of acute or chronic pancreatitis, or pancreatic injury at screening;

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Obesity; Weight Loss

Interventions

Pharmaceutical Preparations; Diet

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Wenhuan W Feng, MD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

wenhuan Feng

CONTACT

+86-25-83106666; fengwh501@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: September 9, 2025
• Study Start: September 16, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: January 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)