Bariatric Surgery vs. Semaglutide vs. Tirzepatide

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Ali Aminian
Study ID
NCT06803888
Phase
PHASE4
Status
Active Not Recruiting

Conditions

  • Obesity and Obesity-related Medical Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bariatric Surgery — PROCEDURE
    Patients receive either RYGB or SG. The surgical risk, the differential impact of each procedure on body weight and other obesity-related diseases, presence of other medical and mental problems, patient's behavioral factors (e.g., postoperative compliance, active smoking), medications, and goals will be considered when the patient and local medical team make a shared decision about the most appropriate surgical procedure.
  • Semaglutide — DRUG
    Semaglutide will be initiated at a dose of 0.25 mg once weekly and will be increased during the dose-escalation period to reach a maintenance dose of up to 2.4 mg once weekly by week 16. If patients do not tolerate a dose during dose escalation, we will consider delaying dose escalation until next visit (for 4 weeks). Dosing for Semaglutide is the FDA-approved dosing schedule. The maintenance dose is 2.4 mg injected subcutaneously once-weekly. The protocol allows for dose reductions in case a participant does not tolerate the recommended target dose of 2.4 mg and may stay at the lower maintenance dose level (e.g., 1.7 mg once weekly), if needed.
  • Tirzepatide — DRUG
    Tirzepatide will be initiated at a dose of 2.5 mg once weekly and will be increased by 2.5 mg every week during the dose-escalation period to reach a maintenance dose of up to 15 mg once weekly by week 20. If patients do not tolerate a dose during dose escalation, we will consider delaying dose escalation until next visit (for 4 weeks). Dosing for Tirzepatide is the FDA-approved dosing schedule. The maintenance dose is 15 mg injected subcutaneously once-weekly. The protocol allows for dose reductions in case a participant does not tolerate the recommended target dose of 15 mg and may stay at the lower maintenance dose level (e.g., 10 mg once weekly), if needed.

Study Details

The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment. These highly effective medications, such as high-dose semaglutide and tirzepatide, are hormone analogues that augment the incretin function and exert multiple physiological effects by activating glucagon-like peptide-1 (GLP-1) and/or glucose-dependent insulinotropic polypeptide (GIP) distributed in various organs. These medications provide an average of 15-22% weight reduction in one-year trials, which had not been seen in the past with medical therapy. While the literature suggests that bariatric surgery is superior to these new highly effective medications, there is no head-to-head comparison between the most common bariatric operations (Roux-en-Y gastric bypass \[RYGB\] and sleeve gastrectomy \[SG\]) with semaglutide (once weekly) and tirzepatide (once weekly). The goal of this Randomized Clinical Trial (RCT) is to compare these effective therapies in patients with severe obesity to provide the best evidence to inform clinical decisions in treating patients with obesity.

Key Dates

Start date
Jan 29, 2025
Status verified
May 2026
Primary completion
Jul 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
125 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Bariatric Surgery
    Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)
  • Active Comparator: Semaglutide
    Semaglutide, which is an incretin-based medication that has been approved for the treatment of obesity, will be used for this arm.
  • Active Comparator: Tirzepatide
    Tirzepatide, which is an incretin-based medication that has been approved for the treatment of obesity, will be used for this arm.

Primary Outcome Measure

The mean percentage weight loss [ Time Frame: First 52 weeks of the study ]

Locations (1)

FacilityCityStateZIPSite coordinators
The Cleveland ClinicClevelandOhio44195-

Find similar trials in Cleveland, OH

By research site
The Cleveland Clinic· Cleveland, OH

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