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New treatment option for Obesity
Official title Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery
ClinicalTrials.gov ID: NCT07163650
What this study is testing
What is Efsubaglutide Alfa Injection?
Efsubaglutide Alfa Injection is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for obesity.
Also referred to as Drug injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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...
You likely can't join if
- people suspected by the investigator of having a potential allergy to the study drug or its components, or those with a history of allergic...
- 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...
- 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...
See the full eligibility 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.
- people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nanjing, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.