Bariatric Surgery vs. Semaglutide vs. Tirzepatide

PHASE4RecruitingINTERVENTIONAL
Enrollment

125

Participants

Timeline

Start Date

January 29, 2025

Primary Completion Date

July 1, 2027

Study Completion Date

December 1, 2027

Conditions
Obesity and Obesity-related Medical Conditions
Interventions
PROCEDURE

Bariatric Surgery

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.

DRUG

Semaglutide

"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."

DRUG

Tirzepatide

"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."

Trial Locations (1)

44195

RECRUITING

The Cleveland Clinic, Cleveland

All Listed Sponsors
collaborator

Ethicon, Inc.

INDUSTRY

lead

Ali Aminian

OTHER