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← All trials/NCT07859150

Not yet recruitingPhase 4

Semaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE)

Semaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE): a Randomized, Double-Blind, Placebo-Controlled Trial

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Estimated enrollment

104

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥30

Primary endpoint

•Mean percentage change in body weight from randomization

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07859150
Org study IDRESURGE

Timeline

Milestones

Study first posted2026-10-05actual
Last update posted2026-10-05actual
Study start2026-10estimated (month precision)
Primary completion2029-04estimated (month precision)
Study completion2029-04estimated (month precision)

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Primary laparoscopic sleeve gastrectomy, Roux-en-Y gastric bypass, or one-anastomosis gastric bypass performed at least 18 months before screening.
•Documented initial clinical response: nadir weight loss of at least 20% TWL from preoperative weight.
•Recurrent weight gain per Section 5.1: regain >25% of maximal weight lost, confirmed on two measurements at least 14 days apart.
•Current BMI >=30 kg/m2, or >=27 kg/m2 with at least one obesity-related complication (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea, metabolic dysfunction-associated steatotic liver disease, or symptomatic osteoarthritis).
•Women of childbearing potential: willing to use highly effective contraception during treatment and for 2 months after the last dose.
•Able and willing to self-inject weekly, complete the injection diary, attend scheduled visits, and provide written informed consent.

Exclusion criteria

•Revisional or conversion bariatric surgery of any type, or revisional surgery planned during the trial period.
•A surgically correctable anatomical cause of regain identified on the pre-enrolment work-up (Section 5.4), including gastro-gastric fistula or symptomatic pouch outlet abnormality, for which the patient elects surgical management.
•Use of any GLP-1-based therapy, tirzepatide, or other anti-obesity medication within 6 months of screening.
•Type 1 diabetes; type 2 diabetes treated with insulin.
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2.
•History of acute or chronic pancreatitis.
•Symptomatic gallstone disease.
•Endoscopically active marginal or peptic ulcer, or anastomotic/sleeve stricture requiring intervention.
•Pregnancy, breastfeeding, or intention to conceive during the trial. Obesity pharmacotherapy is stopped at least 2 months before any planned conception, per current semaglutide labeling and the 2026 Standards.
•Estimated glomerular filtration rate <30 mL/min/1.73 m2; severe hepatic impairment.
•. Malignancy within the past 5 years (excluding treated non-melanoma skin cancer).
•Current severe uncontrolled psychiatric illness, active suicidal ideation, suicide attempt within 5 years, or current or past diagnosed eating disorder.
•Known or suspected alcohol or substance misuse.
•Ongoing treatment with medications with clinically significant effects on body weight (including systemic glucocorticoids for more than 2 weeks).
•Known hypersensitivity to semaglutide or excipients.
•Participation in another interventional trial within 3 months.

Endpoints (10)

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
5
Cardiometabolic biomarkers
2
Other (unclassified)
2
Glycemic / diabetes
1

Weight & body composition

5 endpoints
Primary/protocol endpoint

Mean percentage change in body weight from randomization

Time frame:week 0 to week 68

percent change from baseline, improvement

Secondary/protocol endpoint

absolute weight change

Time frame:Baseline till week 68

descriptive

Secondary/protocol endpoint

BMI change

Time frame:Baseline till week 68

descriptive

Secondary/protocol endpoint

waist circumference change

Time frame:Baseline till week 68

descriptive

Secondary/protocol endpoint

change in fat mass and lean soft tissue mass

Time frame:weeks 0, 32, and 68

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

change in HbA1c

Time frame:Baseline till week 68

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

systolic and diastolic blood pressure

Time frame:Baseline till week 68

descriptive

Secondary/protocol endpoint

total cholesterol, LDL, HDL, and triglycerides

Time frame:Baseline till week 68

descriptive

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

change in IWQOL-Lite-CT total and domain scores

Time frame:Baseline till week 68

change from baseline, improvement

Secondary/protocol endpoint/low confidence

change in GerdQ score

Time frame:Baseline till week 68

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.