Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06734273

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Obesity and Obesity-related Medical Conditions Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location status: Recruiting

Location contact

Sr. Clinical Research Coordinator

CONTACT

[email protected]

312-942-5500

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mounjaro

Drug

In this study, the intervention group (n=21) are patients who will undergo sleeve gastrectomy and receive tirzepatide after surgery. Patients who were selected in this arm will undergo a 4-week dose escalation period. Starting at 6 months 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.

Sleeve gastrectomy

Procedure

Subjects in both the interventional group (n=21) and the control group (n=21) will undergo sleeve gastrectomy.

Primary outcomes

  1. Weight Loss

    Time frame: 12 months after surgery

Secondary outcomes

  1. Weight Loss

    Time frame: 18 months after surgery

  2. Type 2 Diabetes

    Time frame: 12 months after surgery

    Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.

  3. Type 2 Diabetes

    Time frame: 18 months after surgery

    Researchers will use Hemoglobin A1c (%) to measure Type 2 Diabetes. A lower value indicates improvement.

  4. High Blood Pressure

    Time frame: 12 months after surgery

  5. High Blood Pressure

    Time frame: 18 months after surgery

  6. High Cholesterol

    Time frame: 12 months after surgery

    Researchers will measure Cholesterol by the number of cholesterol-lowering medications needed by the subject (#). A lower value indicates improvement.

  7. High Cholesterol

    Time frame: 18 months after surgery

    Researchers will measure Cholesterol by the number of cholesterol-lowering medications needed by the subject (#). A lower value indicates improvement.

  8. Sleep Apnea

    Time frame: 12 months after surgery

    Researchers will measure Sleep Apnea by subject's need for a CPAP (continuous positive airway pressure) machine (Y/N).

  9. Sleep Apnea

    Time frame: 18 months after surgery

    Researchers will measure Sleep Apnea by subject's need for a CPAP (continuous positive airway pressure) machine (Y/N)

  10. Complications/Side Effects

    Time frame: 12 months after surgery

  11. Complications/Side Effects

    Time frame: 18 months after surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Research Administrator

CONTACT

[email protected]

312-942-5500

Sponsors and collaborators

Lead sponsor

Nicholas Skertich

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 16, 2024
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.