DelfaGLP-1 Atlas

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RecruitingPhase 4

Evaluating Anti-Obesity Medications 6 Months After Metabolic Surgery

A Randomized, Double-Blind, Placebo-Controlled, Single-Center Study of Efsubaglutide Alfa in Patients Remaining Obese 6 Months After Metabolic Surgery

Asset

GLP-1 / incretin class catch-all

Listed sites

1

Recruiting sites

1

Enrollment

60

estimated

Study population

Bariatric Surgery, Obesity / overweight

Key I/E criterion

•BMI ≥28

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07163650
Org study ID2025-0631-01

Timeline

Milestones

Study first posted2025-09-09actual
Study start2025-09-16actual
Last update posted2026-01-27actual
Primary completion2026-11-30estimated
Study completion2027-02-28estimated

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Bariatric SurgeryObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
4
Glycemic / diabetes
2
Cardiometabolic biomarkers
1
Other clinical outcomes
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Change in %TWL from baseline to endpoint

Time frame:24 weeks from enrollment

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Proportion of patients with different %TWL levels

Time frame:24 weeks from enrollment

threshold achievement, improvement

Secondary/protocol endpoint

Proportion of patients with normal weight and overweight

Time frame:24 weeks from enrollment

threshold achievement, improvement

Secondary/protocol endpoint

Change in body composition from baseline to endpoint across patient groups

Time frame:24 weeks from enrollment

Total fat mass

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Changes in fasting blood glucose from baseline to endpoint

Time frame:24 weeks from enrollment

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in HbA1c from baseline to endpoint across patient groups

Time frame:24 weeks from enrollment

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Changes in blood pressure from baseline to endpoint

Time frame:24 weeks from enrollment

change from baseline, improvement

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint/low confidence

Remission Status of Obesity-Related Diseases

Time frame:24 weeks from enrollment

categorical status, improvement

componentsT2DM prevention, Systolic BP, change, LDL-C, change, Triglycerides, change, ALT, change

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.