Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery

semaglutide 0.25, 0.5, 1.0, 1.7, 2.4 mg weekly in 4-weekly steps, then 2.4 mg or maximal tolerated dose, with reductions for tolerability permitted and recorded, to 12 months after randomization; in BARI-STEP six patients held reduced doses and the effect stood.

semaglutide escalated to 2.4 mg weekly, continued for 12 months.

matched placebo on the identical schedule. Trigger 1: recurrent weight gain by the consensus definition, regain of more than 25% of the weight lost from nadir, confirmed on a second weight 4 weeks later, then immediate open-label semaglutide. Trigger 2: %TWL still below 20% at 12 months after randomization, then open-label semaglutide for the following 12 months.

Criterion-triggered strategy: matched placebo with identical lifestyle support; guaranteed open-label semaglutide the moment consensus recurrence criteria are met, and in any case 12 months after randomization if response remains suboptimal.

Measured in kilograms from pre-surgery weight at 12 months after randomization, same calibrated scale, morning, light clothing.

Measured in kilograms at 6 and 24 months after randomization

An HbA1c level reflects your average blood sugar over the past two to three months, and any meaningful change typically takes at least 6 weeks to show because red blood cells live for about 3 months. Normal: Below 5.7% Prediabetes: 5.7% to 6.4% Diabetes: 6.5% or higher

Normal blood pressure is less than 120 mm Hg systolic and less than 80 mm Hg diastolic. Systolic (Top Number): Measures the pressure in your arteries when your heart beats and contracts. Diastolic (Bottom Number): Measures the pressure in your arteries when your heart rests between beats. • Normal: Less than 120 mm Hg systolic and less than 80 mm Hg diastolic. • Elevated: 120-129 mm Hg systolic and less than 80 mm Hg diastolic. • Stage 1 Hypertension (High Blood Pressure): 130-139 mm Hg systolic or 80-89 mm Hg diastolic. • Stage 2 Hypertension: 140 mm Hg or higher systolic, or 90 mm Hg or higher diastolic. • Hypertensive Crisis: Higher than 180 mm Hg systolic and/or higher than 120 mm Hg diastolic. This requires immediate emergency medical care

Normal adult values for a lipid panel are measured in milligrams per deciliter (mg/dL): • Total Cholesterol: Below 200 mg/dL is desirable. (Borderline high is 200-239 mg/dL, and high is 240 mg/dL and above.) • LDL ("Bad") Cholesterol: Below 100 mg/dL is optimal. (130-159 mg/dL is borderline high, and 160-189 mg/dL or higher is high.) • HDL ("Good") Cholesterol: 60 mg/dL and higher is protective. Levels below 40 mg/dL for men or below 50 mg/dL for women are considered low. • Triglycerides: Below 150 mg/dL is normal. (Borderline high is 150-199 mg/dL, and high is 200-499 mg/dL.)

A hand grip strength test measures the maximum force of your hand and forearm muscles using a portable device called a handgrip dynamometer.

Position yourself: Sit up straight with your feet flat on the floor. Place your arm by your side with your elbow bent at a 90-degree angle and your wrist in a neutral position.

Hold the device: Adjust the handle so it fits comfortably in your hand. Squeeze hard: Squeeze the handles as hard as you can for about 3 to 5 seconds without moving your arm or resting the device against your body.

Repeat trials: Take three measurements for each hand, resting for 15 to 30 seconds between attempts. Use either the highest score or the average of the trials.

A normal hand grip strength score typically ranges from 40 to 56 kg (88 to 123 lbs) for adult men and 25 to 36 kg (55 to 79 lbs) for adult women aged 20-29.

The IWQOL-Lite-CT (Impact of Weight on Quality of Life-Lite Clinical Trials Version) score ranges from 0 to 100, where 100 represents the best possible quality of life and functioning (meaning zero weight-related impairment). • Total Score Range: 0-100 (higher = better quality of life) • Domain/Composite Scores: 0-100 • Raw scores are converted or transformed to a 0-100 scale for standard reporting.