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Enrollment cut 3% · 30 to 29 participants

Readout moved earlier 30 days · now expected Nov 2026

Primary completion reached 20 Jun 2026 · confirmed actual

Enrollment locked at 175 · estimate confirmed as actual

Secondary endpoints modified

Was: Percent change in body weight from baseline; Absolute change in body weight from baseline; Percent change in body weight from baseline; Absolute change in body weight from baseline; Mean change in Body Mass Index from baseline; Mean change in waist circumference from baseline; Proportion of patients with ≥5% weight loss; Proportion of patients with ≥10% weight loss; Proportion of patients with ≥15% weight loss; Assessment of the adverse events (including Treatment Emergent Adverse Events); Assessment of immunogenicity at screening. Now: Percent change in body weight from baseline; Absolute change in body weight from baseline; Percent change in body weight from baseline; Absolute change in body weight from baseline; Mean change in Body Mass Index from baseline; Mean change in waist circumference from baseline; Proportion of patients with ≥5% weight loss; Proportion of patients with ≥10% weight loss; Proportion of patients with ≥15% weight loss; Assessment of the adverse events (including Treatment Emergent Adverse Events); Assessment of immunogenicity at screening, day 90, and day 180.

Secondary endpoints modified

Was: Change in Liver Enzymes; Change in Glycemic Parameters; Change in Lipid Profile; Change in Anthropometric Measures. Now: Change in Liver Enzymes; Change in Fasting Plasma Glucose; Change in Lipid Profile; Change in Body Weight; Change in Glycated Hemoglobin (HbA1c); Change in Body Mass Index (BMI); Change in Waist-to-Height Ratio.

Tirzepatide added as intervention option alongside semaglutide; enrollment window widened to 6-24 months postoperatively; BMI loss threshold increased to ≤22%.