Bariatric Surgery vs. Semaglutide vs. Tirzepatide

Launched by ALI AMINIAN · Jan 28, 2025

Keywords

ClinConnect Summary

This clinical trial is comparing three different treatments for obesity: bariatric surgery, semaglutide, and tirzepatide. Both semaglutide and tirzepatide are new medications that help people lose weight by acting on hormones in the body. The trial aims to find out which of these treatments works best for individuals who are severely obese, providing important information for doctors and patients about the most effective ways to manage obesity and its related health issues.

To participate in the study, individuals need to be between 18 and 70 years old, have a body mass index (BMI) between 35 and 65, and be eligible for bariatric surgery. They should also be in generally good health and not have lost more than 20 pounds in the three months before the study. Participants will receive one of the treatments and will be monitored for their weight loss and overall health. This trial is important because it will help determine the best options for treating obesity, which affects many people's health and well-being.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Entry into the study would require that the patient:
• • 1. Is a candidate for general anesthesia
• • 2. Is eligible for bariatric surgery (RYGB or SG) based on ASMBS/IFSO 2022 guidelines
• • 3. Is ≥18 and ≤70 years old (both inclusive)
• • 4. has a BMI ≥35 and ≤65 kg/m2 (both inclusive)
• • 5. 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%.
• • 6. No weight loss \> 20 lbs. in 3 months before screening (self-reported)
• • 7. Has the ability and willingness to participate in the study, provide informed consent, and agree to any of the arms involved in the study.
• • 8. Is able to understand the options and to comply with the requirements of each arm.
• • 9. Has a negative urine pregnancy test at randomization visit for women of childbearing potential.
• • 10. Women of childbearing age must agree to use reliable method of contraception for 2 years.
• Exclusion Criteria:
• • 1. Significant cardiac or atherosclerotic disease (planned to undergo cardiac, coronary, carotid, or peripheral artery revascularization procedures in the next 12 months)
• • 2. Severe uncompensated cardiopulmonary disease leading to American Society of Anesthesiologists Class IV or V
• • 3. Classified as New York Heart Association Class IV
• • 4. Left ventricular ejection fraction \<25% at the time of screening (if already known)
• • 5. Myocardial infarction, unstable angina, stroke, transient ischemic attack, heart surgery, coronary stent placement in the past 6 months
• • 6. Prior bariatric surgery of any kind
• • • Intragastric balloon that has been removed at least 6 months prior to the first study visit is allowed.
• • 7. History of solid organ transplant
• • 8. Type 1 diabetes or autoimmune diabetes
• • 9. eGFR \< 30 mL/min/1.73 m2 or being on dialysis
• • 10. History of deep vein thrombosis, pulmonary embolism, or venous thromboembolism
• • 11. On therapeutic dose of anticoagulants such as warfarin or direct oral anticoagulants (DOACs)
• • 12. Decompensated cirrhosis characterized by presence of ascites, hepatic encephalopathy, portal hypertension, or esophageal varices.
• • 13. History of severe anemia defined as hemoglobin less than 8 g/dL
• • 14. Use of investigational therapy
• • 15. Liver transaminase level or alkaline phosphatase \>200 U/L
• • 16. Significant alcohol use (average \>2 drinks/day)
• • 17. Presence of active malignancy (except non-melanoma skin cancer)
• • 18. Life expectancy less than 3 years due to concomitant diseases
• • 19. Major mental health, psychological disorders, or substance abuse disorders that in the opinion of the investigators could disqualify the patient from bariatric surgery
• • 20. Any condition or major illness that, in the investigator's judgment, places the subject at undue risk by participating in the study
• • 21. Unable to understand the risks, benefits and compliance requirements of study
• • 22. Lack capacity to give informed consent
• • 23. Plans to move outside the primary location of study (northeast Ohio) within the next 12 months
• • 24. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
• • 25. Hypothalamic obesity
• • 26. Continuous treatment with semaglutide (once weekly) or tirzepatide (once weekly) \<60 days before screening
• • 27. History of semaglutide (once weekly) or tirzepatide (once weekly) use in the past for obesity with lack of clinical response
• • 28. Chronic use of systemic steroids
• • 29. 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.
• • 30. Acute pancreatitis \< 180 days before screening
• • 31. History or presence of chronic pancreatitis
• • 32. History of Crohn's disease
• • 33. Known or suspected allergy to semaglutide, tirzepatide, excipients, or related products
• • 34. A personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
• • 35. Previous participation in this trial and got randomized to one of the study groups but did not proceed.