Bariatric Surgery vs. Semaglutide vs. Tirzepatide

Korábbi kezelés

• Prior bariatric surgery of any kind
  • Intragastric balloon that has been removed at least 6 months prior to the first study visit is allowed.
• Use of investigational therapy
• Life expectancy less than 3 years due to concomitant diseases
• Continuous treatment with semaglutide (once weekly) or tirzepatide (once weekly) <60 days before screening
• Chronic use of systemic steroids
• Uncontrolled thyroid disease: thyroid stimulating hormone (TSH) > 6.0 mIU/L or < 0.1 mIU/L
  • Note: Patients receiving treatment for hypothyroidism can be included if their thyroid hormone replacement dose has been stable for at least 3 months.
• Acute pancreatitis < 180 days before screening
• Previous participation in this trial and got randomized to one of the study groups but did not proceed.

Más betegség

• Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
• Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
• Classified as New York Heart Association Class IV
• Myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months
• History of solid organ transplant
• Type 1 diabetes or autoimmune diabetes
• History of deep vein thrombosis, pulmonary embolism, or venous thromboembolism
• Decompensated cirrhosis characterized by presence of ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
• Presence of active malignancy (except non-melanoma skin cancer)
• Major mental health, psychological disorders, or substance abuse disorders that in the opinion of the investigators could disqualify the patient from bariatric surgery
• Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
• History of semaglutide (once weekly) or tirzepatide (once weekly) use in the past for obesity with lack of clinical response
• History of Crohn's disease
• Known or suspected allergy to semaglutide, tirzepatide, excipients, or related products
• A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)

Laborértékek

• Left ventricular ejection fraction <25% at the time of screening (if already known)
• eGFR < 30 mL/min/1.73 m2 or being on dialysis
• History of severe anemia defined as hemoglobin less than 8 g/dL
• Liver transaminase level or alkaline phosphatase >200 U/L

Egyéb

• On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)
• Significant alcohol use (average >2 drinks/day)
• Unable to understand the risks, benefits and compliance requirements of study
• Lack capacity to give informed consent
• Plans to move outside the primary location of study (northeast Ohio) within the next 12 months
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
• Hypothalamic obesity
• History or presence of chronic pancreatitis

• Entry into the study would require that the patient:
• Is a candidate for general anesthesia
• Is eligible for bariatric surgery (RYGB or SG) based on ASMBS/IFSO 2022 guidelines
• Is ≥18 and ≤70 years old (both inclusive)
• has a BMI ≥35 and ≤65 kg/m2 (both inclusive)
• Patients with and without T2DM are eligible for the study. Patients with T2DM should have been on a stable dose of anti-diabetic medication (including insulin but not semaglutide or tirzepatide) for at least 3 months prior to entry, with HbA1c ≤12%.
• No weight loss > 20 lbs. in 3 months before screening (self-reported)
• Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study.
• Is able to understand the options and to comply with the requirements of each arm.
• Has a negative urine pregnancy test at randomization visit for women of childbearing potential.
• Women of childbearing age must agree to use reliable method of contraception for 2 years.