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New treatment option for Obesity
Official title Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents
ClinicalTrials.gov ID: NCT06575738
What this study is testing
What is Injectable semaglutide or injectable tirzepatide?
Injectable semaglutide or injectable tirzepatide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study plans to learn more about what happens to the body after bariatric surgery in people 12 to 24 years old. The study aims to understand why people respond differently to bariatric surgery and how to define success beyond weight loss alone.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 24
You may be able to join if
- Observation Phase
- 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
You likely can't join if
- 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
See the full eligibility criteria
- Observation Phase
- 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 24 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.