Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents

Observation Phase

Inclusion criteria

• Signed and dated informed consent form
• Willingness to comply with all study procedures and availability for the duration of the study
• Male or female biological sex, age 12 through 24 years
• In the preoperative pathway for vertical sleeve gastrectomy

Exclusion criteria

• Planned Roux-en-Y gastric bypass
• Hypothalamic obesity
• Type 2 Diabetes
• Current use of oral glucocorticoids (i.e. within 10 days of baseline visit)
• Current use of insulin

Intervention/Treatment Phase

Inclusion criteria

• Signed and dated informed consent form
• Status post vertical sleeve gastrectomy
• Male or female biological sex, age 12 through 24 years
• Meeting minimum nutrition goals
• Obesity: age 12-17 years: BMI ≥95th%ile for age/sex | age 18-24 years: BMI ≥ 30kg/m^2
• If entering the Intervention phase from the Observational phase: ≤22% BMI loss at 6-24 months postop
• If entering the Intervention phase from the existing patient pool: ≤22% BMI loss at 6-24 months postop

Exclusion criteria

• Surgically correctable cause of suboptimal postoperative weight loss
• Known hypersensitivity to any component of semaglutide
• Personal or family history of medullary thyroid carcinoma
• Personal history of multiple endocrine neoplasia type 2
• Hypothalamic Obesity
• Type 2 Diabetes
• History of pancreatitis
• Uncontrolled hypertension
• Clinically significant arrhythmia or heart disease that could be exacerbated by increased heart rate
• Malignant neoplasm within the last 5 years
• Untreated thyroid disorder
• Tanner Stage 1
• Baseline alanine transaminase (ALT) or aspartate aminotransferase (AST) ≥ 5x upper limit of normal
• Baseline Creatinine >1.2mg/dL
• Active treatment for bulimia nervosa
• Active major psychiatric disorder limiting informed consent
• Suicidal ideation of type 4 or 5 on Columbia-Suicide Severity Rating Scale (C-SSRS)
• Intentional self-harm within the previous 1 month
• Severe unmanaged depression, defined by Center for Epidemiological Studies Depression (CESD) score of 26 or greater and by clinical evaluation
• Recent change to concomitant medications for hypertension, dyslipidemia, depression or anxiety (<4 weeks prior to enrollment)
• Use of oral glucocorticoids (within 10 days of baseline visit)
• Use of metformin (within 3 months of baseline visit)
• Use of insulin secretagogues (within 4 half-lives of the medication of baseline visit)
• Current use of insulin
• Use of anti-obesity medications (within 4 half-lives of the medication of baseline visit)
• Current pregnancy
• For females of reproductive potential: Plan to become pregnant in the next 8 months
• For females of reproductive potential: Not on contraception (i.e. two forms of birth control for example oral birth control pills and condoms) for at least 1 month prior to enrollment and agreement to use these during study participation and for an additional 8 weeks after the final dose of study medication