Comparing bariatric surgery with new obesity medications
Efficacy and Safety of Bariatric Surgery, Semaglutide Once Weekly, and Tirzepatide Once Weekly in Patients With Obesity
This study is testing whether bariatric surgery or two new obesity medications can help people with obesity lose more weight over a year.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06803888 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy) with two new anti-obesity medications, semaglutide and tirzepatide. It is a randomized, non-blinded study involving 125 patients with a BMI between 35 and 65 kg/m2 who are seeking treatment for obesity. Participants will be assigned to one of three groups: bariatric surgery, semaglutide, or tirzepatide, with the primary endpoint being the mean percentage weight loss after 12 months. The study will also include a second phase to follow participants for an additional year to assess long-term outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 70 with a BMI of 35 to 65 kg/m2 who are eligible for bariatric surgery.
Not a fit: Patients who have recently lost more than 20 lbs in the three months prior to screening may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the most effective treatment options for obesity, potentially improving patient outcomes.
How similar studies have performed: While bariatric surgery has been shown to be effective, this study is novel as it directly compares it with new anti-obesity medications in a head-to-head format.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cleveland, Ohio
- The Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Ali Aminian — The Cleveland Clinic
- Study coordinator: Chytaine Hall
- Email: hallc1@ccf.org
- Phone: (216) 445-3983
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.