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

Nicholas Skertich

Status and phase: Enrolling; Early Phase 1

Conditions: Obesity and Obesity-related Medical Conditions

Treatments: Drug: Mounjaro; Procedure: Sleeve Gastrectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06734273

24101008

Details and patient eligibility

About

This study examines whether adding tirzepatide-a medication that helps with weight loss-after sleeve gastrectomy surgery can help people lose more weight after the surgery; better improve conditions like Type 2 diabetes, high blood pressure, high cholesterol, and sleep apnea after surgery and; whether this causes more complications or side effects compared to surgery alone.

Enrollment: 42 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

SG-T: sleeve gastrectomy with tirzepatide

Experimental group

Description:

In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months after surgery they will receive weekly 2.5mg doses (for 4 weeks). Afterwards, they will receive weekly 5mg doses. They will maintain this dose until 12 months after surgery.

Treatment:

Procedure: Sleeve Gastrectomy

Drug: Mounjaro

SG-A: sleeve gastrectomy alone

Active Comparator group

Description:

In this study the control group (n=21) are patients who will undergo sleeve gastrectomy alone.

Treatment:

Procedure: Sleeve Gastrectomy