Actively Recruiting
A Randomized, Double-Blind, Placebo-Controlled Study of Efsubaglutide Alfa in Adults Remaining Obese 6 Months After Metabolic Surgery
Led by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Updated on 2026-01-27
60
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of efsubaglutide alfa in adults aged 18 to 55 who remain obese six months after metabolic surgery. The study aims to see if this medication can help normalize weight and improve related health conditions, assessing its benefits for managing obesity after surgery. This phase 4 clinical trial is randomized, double-blind, and placebo-controlled. Participants are randomly assigned to one of two groups: one group receives efsubaglutide alfa injections along with diet and exercise guidance, while the other group receives only diet and exercise guidance without the drug. Efsubaglutide alfa is given as a subcutaneous injection once weekly, starting at 1 mg/week for two weeks and gradually increasing to 9 mg every two weeks by week 13. The treatment period lasts 24 weeks. During the study, participants will be monitored through regular assessments including body weight, body composition, blood pressure, fasting blood glucose, and HbA1c levels. Researchers will track changes in total weight loss percentage and remission of obesity-related diseases over the 24-week study. Safety will be closely observed, and all participants will receive diet and exercise counseling throughout the trial period.
CONDITIONS
Brief Title
Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 6 months after metabolic surgery
- Age between 18 and 55 years
- Body Mass Index (BMI) of 28 kg/m² or higher
- Voluntarily sign informed consent and agree to follow the study requirements throughout the trial period
You will not qualify if you...
- Potential allergy to efsubaglutide alfa or its components
- Use of GLP-1 receptor agonists within 3 months prior to screening
- Use of weight-affecting medications or supplements within 3 months prior to screening
- Current or recent use of weight-loss medications within 3 months prior to screening
- Participation in other clinical trials with investigational drugs within 3 months prior to screening
- History of depression or severe psychiatric disorders such as schizophrenia or bipolar disorder
- Uncontrolled hypertension despite medication (systolic >160 mmHg or diastolic >100 mmHg)
- History of malignancy
- History of cardiac diseases including recent heart attack or severe arrhythmia
- Stroke or transient ischemic attack within 6 months prior to screening
- History or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
- History of acute or chronic pancreatitis or pancreatic injury
- Limb deformities or amputations preventing accurate body measurements
- Major surgery, severe trauma, or severe infection within 1 month prior to screening
- History of suicidal tendencies or attempts
- Planned surgery during the study period
- Positive test for HIV, hepatitis B or C, or syphilis antibodies at screening
- History of alcohol abuse within 1 month prior to screening
- Significant abnormalities on ECG including certain heart blocks, long QT syndrome, or severe arrhythmias
- Other risk factors for torsades de pointes or related heart conditions
- Recent blood donation or significant blood loss within 3 months prior to screening
- Hemoglobin below 110 g/L for males or below 100 g/L for females
- Any other factors deemed unsuitable by the investigator for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive daily efsubaglutide alfa injections with dose escalation over 24 weeks, alongside guidance on diet and exercise.
Regular visits for monitoring during the 24-week treatment period
Trial Site Locations
Total: 1 location
1
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Actively Recruiting
Research Team
W
wenhuan Feng
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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