New drug aims to help patients shed pounds after failed weight-loss surgery
NCT ID NCT07163650
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a drug called efsubaglutide alfa to help people who are still obese six months after weight-loss surgery lose more weight. About 60 adults aged 18 to 55 with a BMI of 28 or higher will take the drug or a placebo. The main goal is to see how much weight they lose and if the drug is safe.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2025
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nanjing Drum Tower Hospital
RECRUITINGNanjing, Jiangsu, China
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Other studies related to the condition(s) this trial covers.
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- Do GLP-1 Weight-Loss drugs change how teens eat and feel?
- Can electrical muscle stimulation boost exercise benefits after menopause?
- Can a cold cloth on the neck calm Post-Surgery nausea?