No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
12 – 24
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
University of Colorado, Denver · Other
Who this trial is looking for
This trial is looking for teenagers and young adults, ages 12 to 24, who are planning to have or have already had weight loss surgery. Participants will help researchers understand body changes after surgery and whether a medication can support weight loss.
Are You a Good Fit for This Trial?
Must not be takingOral glucocorticoidsInsulin
Rules you outType 2 diabetesHypothalamic obesityPancreatitis
You may be able to join if
I am 12 to 24 years old.
I am planning to have vertical sleeve gastrectomy.
I have signed and dated an informed consent form.
I will follow all study procedures.
I have completed weight loss surgery.
You may not be able to join if
I have type 2 diabetes.
I am currently using insulin.
I have hypothalamic obesity.
I have a history of pancreatitis.
I have had a heart condition that worsens with increased heart rate.
I have had a malignant tumor in the last 5 years.
I have severe unmanaged depression.
I am pregnant.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 or tirzepatide) can help people 12 to 24 years old who, between 6 and 24 mont…
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 or tirzepatide) can help people 12 to 24 years old who, between 6 and 24 months after bariatric surgery, have not lost as much weight as expected.
Trial Locations
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City
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Status
Eligibility Criteria
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
Ex…
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
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