Bariatric Surgery vs. Semaglutide vs. Tirzepatide

What Was Tested

The trial (phase 4) is built around Tirzepatide and Semaglutide.

The recent introduction of the new generation of anti-obesity medications (AOMs) will change the future of obesity treatment.

It had three arms (groups): Bariatric Surgery (active comparator), Semaglutide (active comparator) and Tirzepatide (active comparator).

Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG).

Semaglutide, which is an incretin-based medication that has been approved for the treatment of obesity, will be used for this arm.

Tirzepatide, which is an incretin-based medication that has been approved for the treatment of obesity, will be used for this arm.

The registry classes the interventions as drug and procedure.

More on the Plan

The study has 2 phases: the first 12 months for the assessment of the primary endpoint ( mean percentage weight loss) and the second 12 months as the extension phase of the study to mimic the real-life setting.

Findings at the end of each phase will be separately reported.

A randomized trial of adult patients with a BMI of 35-65 kg/m2 who seek treatment for obesity at Cleveland Clinic will be performed.

Patients who meet the ASMBS/IFSO 2022 guidelines for bariatric surgery will be invited for possible enrollment.

Who Took Part

140 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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). No weight loss \> 20 lbs. in 3 months before screening (self-reported).

The full record lists 10 inclusion and 35 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

The Tirzepatide group and the comparison group ran side by side rather than switching.

Everyone knew when Tirzepatide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2025-01-29 with completion listed for 2027-07-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Mean percentage total body weight loss at Week 52 (time frame: Baseline to Week 52 after treatment initiation).

It also tracked 18 secondary outcomes, for example Percentage of Participants Achieving Weight Loss Milestones (Body weight related end points), Absolute Change in Weight (Body weight related end points), Absolute Change in BMI (Body weight related end points), Excess Weight Loss Percentage (Body weight related end points), Change in Waist Circumference (Body weight related end points) and Change in waist-to-height ratio (WHtR).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Tirzepatide and Semaglutide in 140 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page and the Semaglutide compound page, all human trials.