Recruiting EARLY_PHASE1 Obesity and Obesity-related Medical Conditions

New treatment option for Obesity and Obesity-related Medical Conditions

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

ClinicalTrials.gov ID: NCT06734273

What this study is testing

What is Mounjaro?

Mounjaro is an investigational medicine, given as an once-weekly, being studied as a potential treatment for obesity and obesity-related medical conditions.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
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.
  • Phase 1: an early, usually small safety study
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 65

You may be able to join if

  • 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...
  • Undergoing primary sleeve gastrectomy

You likely can't join if

  • 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
See the full eligibility criteria
Who can join
  • 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
What rules you out
  • 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

The study team makes the final eligibility decision.

Where it's taking place

  • Chicago, Illinois, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.