NCT06575738 · University of Colorado, Denver
Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide in Adolescents
(PRESSURE)
What this study is about
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.
View original scientific description
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. The study also plans to learn more about whether a medication (semaglutide) can help people 12 to 24 years old who, between 1 and 2 years after bariatric surgery, have not lost as much weight as expected.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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: ≤20% BMI loss at 1 year postop
- If entering the Intervention phase from the existing patient pool: ≤20% BMI loss at 1-2 years 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
Where
- Aurora, Colorado
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 12, 2026 · Source of record for eligibility and locations