Early Re-Initiation of Semaglutide Post Sleeve Gastrectomy in Youth

Обзор

This is a Phase 3a, randomized, parallel-controlled trial designed to compare the early re-initiation of semaglutide, starting two weeks after sleeve gastrectomy, to standard care (no pharmacotherapy following surgery). The trial will involve 150 youth with severe obesity who have been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery. Participants will be randomized to either (1) semaglutide 2.4 mg weekly or (2) standard care for 24 months. Primary, secondary, and tertiary outcomes will be assessed at multiple time points: 1-month, day of surgery, and 1-, 3-, 6-, 9-, 12-, 18-, and 24-months postoperatively. We hypothesize that early re-initiation of semaglutide will be safe, well-tolerated, and lead to greater improvements in obesity, cardiometabolic risk, and eating behaviors.

Подробное описание

Study Design: Phase 3a Randomized Controlled Trial of Early Re-initiation of Semaglutide After Sleeve Gastrectomy in Youth with Severe Obesity

Study Type: Interventional (Clinical Trial)

Study Phase: Phase 3a

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Participants: Estimated Enrollment - 150 participants

Population:

Youth aged \[12-18\] with severe obesity who have:

Undergone sleeve gastrectomy

Been on semaglutide 2.4 mg weekly for at least 3 months prior to surgery

Intervention Arms:

Arm 1: Semaglutide Re-initiation Group

Semaglutide 2.4 mg once weekly

Re-initiated 2 weeks after sleeve gastrectomy

Continued for 24 months postoperatively

Arm 2: Standard Care Group

No pharmacotherapy postoperatively

Routine postoperative clinical follow-up for 24 months

Assessment Time Points:

Preoperative Assessments:

1 month before surgery

Day of surgery

Postoperative Assessments:

1 month

3 months

6 months

9 months

12 months

18 months

24 months

Outcomes:

Primary Outcome:

Change in BMI or BMI z-score from baseline to 24 months

Secondary Outcomes:

Safety and tolerability of early semaglutide re-initiation

Changes in weight and waist circumference

Changes in cardiometabolic markers (e.g., HbA1c, lipids, blood pressure)

Tertiary Outcomes:

Changes in eating behaviors

Вмешательства

• Препарат Semaglutide 2.4 mg
  The dosing regimen will follow standard titration protocols, starting with a dose of 0.25 mg weekly for the first month, with gradual increases in dosage each month to a target dose of 2.4 mg weekly by the fifth month. To minimize the potential for side effects impacting daily activities, youth in the semaglutide group will be instructed to administer the medication weekly on Fridays.

Первичные конечные точки

• Percent Body Mass Index [Срок оценки: From enrollment to the end of the end of the study at 24 months]

Вторичные конечные точки (1)

• Modified percent time in range [Срок оценки: From enrollment to the end of the study period at 24 months]

Критерии участия

Критерии включения

• ages 12 to 18 years
• Tanner stage 3 or higher
• severe obesity (defined as a BMI greater than 35 kg/m2 or BMI ≥140% of the 95th percentile)
• currently undergoing primary surgical weight loss through the pediatric bariatric surgery pathway at Children's Hospital Los Angeles
• be willing to have blood collected before and after surgical procedure at defined points
• be willing to have clinical data entered into a prospective database; 8) presence of a consenting caregiver
• be taking semaglutide 2.4 mg weekly as part of their routine medical care prior to surgery as part of their obesity treatment program, apart from any planned surgical procedure.

Критерии исключения

• have a previous diagnosis of type 1 diabetes
• taking any medications known to influence body composition or prevent weight loss or promote weight gain (e.g. prednisone)
• have been diagnosed with syndromes or diseases that may influence the postoperative course (e.g., Cushing syndrome, Down syndrome, Prader Willi Syndrome)
• have significant comorbid medical conditions necessitating frequent hospitalization that may require interruption of medications and/or that would make early re-initiation of semaglutide unsafe due to the other medical comorbidities
• refuse to comply with eligibility criteria.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Children's Hospital Los Angeles — Los Angeles

Идентификаторы

NCT: NCT06934655 · APP-IP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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