IRB Study Number 24-915
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Digestive Disease & Surgery Institute
Description
The Cleveland Clinic is conducting an exciting study comparing bariatric surgery with two new weight loss medication shots—semaglutide (also known as Wegovy or Ozempic) and tirzepatide (also known as Zepbound or Mounjaro).
How the Clinical Trial Works:
· Participants are randomly assigned (by computer) to one of three treatment groups: bariatric surgery, semaglutide, or tirzepatide. Neither patients nor providers can choose the assigned treatment.
· If randomly assigned to medication therapy, one of two medications (semaglutide or tirzepatide) will be provided free of charge for one year.
· If randomly assigned to bariatric surgery, you are expected to undergo bariatric surgery. The study will not cover the cost of bariatric surgery.
Inclusion Criteria
Inclusion Criteria
- Age between 18 and 70 years old
- BMI between 35 and 65 kg/m2
Exclusion Criteria
- Prior bariatric surgery of any kind
- History of blood clots
- On blood thinner
- Type 1 or autoimmune diabetes
- Severe kidney disease or being on dialysis
- Chronic use of systemic steroids
- Continuous treatment with semaglutide (once weekly) or tirzepatide (once weekly) <60 days before screening
- History of semaglutide (once weekly) or tirzepatide (once weekly) use in the past for obesity with lack of clinical response
- Weight loss > 20 lbs. in 3 months before screening
