Efsubaglutide alfa for weight loss after metabolic surgery
A Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Efsubaglutide Alfa in Patients Remaining Obese 6 Months After Metabolic Surgery
This trial will test whether efsubaglutide alfa helps people who remain obese six months after metabolic surgery lose weight and improve obesity-related health problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT07163650 on ClinicalTrials.gov |
What this trial studies
This Phase 4 interventional study enrolls adults (18–55 years) who remain with BMI ≥28 kg/m² six months after metabolic surgery and gives them efsubaglutide alfa injections alongside diet and exercise guidance. The study monitors weight change, safety, and metabolic outcomes to see if early post-surgery use of efsubaglutide facilitates greater weight loss and remission of related conditions. Participants with recent use of GLP-1 receptor agonists or other weight-affecting medications are excluded to isolate the drug effect. Procedures will be performed at the lead site with regular follow-up visits to record efficacy and adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18–55 with BMI ≥28 kg/m² who are six months post metabolic surgery and can follow study requirements and give informed consent.
Not a fit: Patients who recently used GLP-1 receptor agonists or other weight-affecting drugs, who have allergies to the study drug, or who fall outside the age or BMI criteria are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, efsubaglutide alfa could help more people reach healthy weight and reduce obesity-related comorbidities after metabolic surgery.
How similar studies have performed: Other GLP-1 receptor agonists have shown meaningful weight loss in people with obesity, but efsubaglutide alfa specifically has limited published data in the early post-metabolic surgery population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
* 6 months after metabolic surgery
* 18 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.
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;
* 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;
* Presence of limb deformities or amputations preventing accurate measurement of height, weight, or other anthropometric parameters;
* Major or moderate surgery, severe trauma, or severe infection within 1 month prior to screening, deemed unsuitable for study participation by the investigator;
* History of suicidal tendencies or suicide attempts;
* Anticipated surgery during the study period;
* Participants testing positive for HIV antibodies, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies, or syphilis antibodies at 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;
* History of other risk factors for torsades de pointes, such as hypokalemia at screening, family history of long QT syndrome, or concomitant use of QT/QTc-prolonging medications at screening; ⑥ Blood donation volume and/or blood loss ≥400 mL within 3 months prior to screening, or hemoglobin \<110 g/L (males) or \<100 g/L (females); ⑦ Presence of any other factors deemed by the investigator to potentially affect the efficacy or safety evaluation of this study, rendering the subject unsuitable for participation.
Where this trial is running
Nanjing, Jiangsu
- Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: wenhuan Feng
- Email: fengwh501@163.com
- Phone: +86-25-83106666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.