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← All trials/NCT06734273

RecruitingPhase EARLY_1

Randomized Control Trial of Sleeve Gastrectomy With Tirzepatide in Maximizing Weight Loss

Lead sponsor

Nicholas Skertich

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

1

Estimated enrollment

42

Study population

Bariatric Surgery, Obesity / overweight

Eligibility highlights

•BMI ≥35

Primary endpoint

•Weight Loss

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 IDNCT06734273
Org study ID24101008

Timeline

Milestones

Study first posted2024-12-16actual
Study start2025-03-10actual
Last update posted2026-05-08actual
Primary completion2027-09estimated (month precision)
Study completion2028-09estimated (month precision)

Assets

Investigational agents

Tirzepatide

Who this study enrolls

Bariatric SurgeryObesity / overweight

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Adult 18 to 65 years of age
•Body Mass Index >35 with comorbidity of Type 2 Diabetes and/or Hypertension and/or Hyperlipidemia and/or Obstructive Sleep Apnea OR Body Mass Index >40 with or without comorbidity
•Undergoing primary sleeve gastrectomy

Exclusion criteria

•Prior metabolic and bariatric surgery
•Prior use of GLP-1 agonist
•Prior history of pancreatitis
•Personal/family history of medullary thyroid cancer or MEN type 2
•Secondary cause of obesity
•Any eating disorder
•Pregnancy/lactation
•History of acute coronary syndrome or myocardial infarction
•History of stroke
•Hepatic dysfunction: AST/ALT >3 ULN
•Renal dysfunction eGFR<45ml/min/1.73m2
•Active malignancy
•History of diabetic retinopathy
•History of gastroparesis

Endpoints (12)

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

Cardiometabolic biomarkers
4
Weight & body composition
2
Glycemic / diabetes
2
Safety / tolerability / PK
2
Other clinical outcomes
2

Weight & body composition

2 endpoints
Primary/protocol endpoint/low confidence

Weight Loss

Time frame:12 months after surgery

descriptive, improvement

Secondary/protocol endpoint/low confidence

Weight Loss

Time frame:18 months after surgery

descriptive, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Type 2 Diabetes

Time frame:12 months after surgery

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Type 2 Diabetes

Time frame:18 months after surgery

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Cardiometabolic biomarkers

4 endpoints
Secondary/protocol endpoint

High Blood Pressure

Time frame:12 months after surgery

categorical status, improvement

Secondary/protocol endpoint

High Blood Pressure

Time frame:18 months after surgery

categorical status, improvement

Secondary/protocol endpoint

High Cholesterol

Time frame:12 months after surgery

event count, improvement

Secondary/protocol endpoint

High Cholesterol

Time frame:18 months after surgery

event count, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint/low confidence

Complications/Side Effects

Time frame:12 months after surgery

descriptive

Secondary/protocol endpoint/low confidence

Complications/Side Effects

Time frame:18 months after surgery

descriptive

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint

Sleep Apnea

Time frame:12 months after surgery

categorical status, improvement

Secondary/protocol endpoint

Sleep Apnea

Time frame:18 months after surgery

categorical status, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 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 6, 2026 snapshot.