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ObesityPhase 1PRESSURENCT06575738

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

A Phase 1 study testing Injectable semaglutide or injectable tirzepatide and Standard postoperative care in people with Obesity and Adolescent Obesity, run by University of Colorado, Denver at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 24 years
What is being tested?
Injectable semaglutide or injectable tirzepatide and Standard postoperative care
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
11 Oct 2024to 1 Oct 2027
Phase
Phase 1

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 24 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
  • Signed and dated informed consent form
  • Status post vertical sleeve gastrectomy
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  • 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

Who cannot join

  • 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
Show all 34Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jaime Moore, MD MPH contact

303-724-8419

jaime.moore@cuanschutz.edu

United States1 site, 1 recruiting

  • Childrens Hospital Colorado

    Aurora, Colorado, 80045

    Jaime Moore, MD MPH, 303-724-8419, jaime.moore@cuanschutz.edu

    Recruiting

Other trials in United States

About this study

Official title: Physiologic Response to Bariatric Surgery and the Impact of Adjunct Semaglutide - in Adolescents (the PRESSURE Trial)

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.

Being tested
Injectable semaglutide or injectable tirzepatide, Standard postoperative care
Keywords
Obesity, Anti-obesity medication, Bariatric Surgery, Bariatric Surgery Post Operative Outcomes, Semaglutide, Sleeve gastrectomy
Medical subject headings
Obesity, Pediatric Obesity, Body-Weight Trajectory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Injectable semaglutide or injectable tirzepatideDrug

    Subcutaneous weekly injectable medication

  • Standard postoperative careBehavioural

    Standard postoperative care consists of behaviorally-focused interventions delivered by the interdisciplinary Bariatric Surgery Center team targeting nutrition, physical activity, sleep, and mental health at standard postoperative intervals.

Study groups in NCT06575738
Study groupRoleWhat they receive
ObservationalNo interventionParticipants complete a set of standardized measures before bariatric surgery, 3 months postoperatively, and 6 months postoperatively.
Active Medication + Standard Postoperative CareExperimentalParticipants can be enrolled between 6 and 24 months postoperatively and will receive usual interdisciplinary postoperative care plus weekly subcutaneous injectable semaglutide or tirzepatide for 26 weeks. Initial dose is 0.25mg (semaglutide) or 2.5mg (tirzepatide) and is escalated every 4 weeks as tolerated up to the max dose of 2.4mg for semaglutide or 15mg for tirzepatide for a total exposure of 26 weeks.
Receives: Drug: Injectable semaglutide or injectable tirzepatide; Behavioral: Standard postoperative care
Standard Postoperative CareActive comparatorParticipants can be enrolled between 6 to 24 months postoperatively and will receive usual interdisciplinary postoperative care.
Receives: Behavioral: Standard postoperative care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Observational phase: Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels

    GLP1 levels are measured prior to an oral mixed meal tolerance test

    Measured: Baseline, 6 months postoperatively

  2. Observational phase: Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels

    GLP1 levels are measured during an oral mixed meal tolerance test

    Measured: Baseline, 6 months postoperatively

  3. Observational phase: Change in insulin sensitivity (IS), measured by fasting blood insulin levels

    Fasting insulin levels are measured. IS is defined as 1/fasting insulin

    Measured: Baseline, 6 months postoperatively

  4. Observational phase: Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)

    Percent FFM is calculated as (1-Percent Fat Mass) from DXA

    Measured: Baseline, 6 months postoperatively

  5. Observational phase: Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry

    RMR from canopy indirect calorimetry

    Measured: Baseline, 6 months postoperatively

  6. Observational phase: Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor

    Mean 24 hour systolic BP

    Measured: Baseline, 6 months postoperatively

  7. Observational phase: Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram

    Resting supine 2-dimensional echocardiogram

    Measured: Baseline, 6 months postoperatively

  8. Intervention phase: Change in BMI

    [(BMI at 26 weeks-Weight at Intervention Baseline)]/(BMI at Intervention Baseline)] * 100

    Measured: Baseline, 26 weeks

Secondary outcomes (21)

  1. Change in fasting glucagon-like peptide-1 (GLP1), measured by blood levels

    GLP1 levels are measured prior to an oral mixed meal tolerance test

    Measured: Baseline, 3 months postoperatively

  2. Change in stimulated glucagon-like peptide-1 (GLP1), measured by blood levels

    GLP1 levels are measured during an oral mixed meal tolerance test

    Measured: Baseline, 3 months postoperatively

  3. Change in fasting Peptide YY (PYY), measured by blood levels

    PYY levels are measured prior to an oral mixed meal tolerance test

    Measured: Baseline, 3 months postoperatively

  4. Change in fasting Peptide YY (PYY), measured by blood levels

    PYY levels are measured prior to an oral mixed meal tolerance test

    Measured: Baseline, 6 months postoperatively

  5. Change in stimulated Peptide YY (PYY), measured by blood levels

    Plasma PYY levels are measured during an oral mixed meal tolerance test

    Measured: Baseline, 3 months postoperatively

  6. Change in stimulated Peptide YY (PYY), measured by blood levels

    Plasma PYY levels are measured during an oral mixed meal tolerance test

    Measured: Baseline, 6 months postoperatively

  7. Change in fasting ghrelin, measured by blood levels

    Ghrelin levels are measured prior to an oral mixed meal tolerance test

    Measured: Baseline, 3 months postoperatively

  8. Change in fasting ghrelin, measured by blood levels

    Ghrelin levels are measured prior to an oral mixed meal tolerance test

    Measured: Baseline, 6 months postoperatively

  9. Change in stimulated ghrelin, measured by blood levels

    Ghrelin levels are measured during an oral mixed meal tolerance test

    Measured: Baseline, 3 months postoperatively

  10. Change in stimulated ghrelin, measured by blood levels

    Ghrelin levels are measured during an oral mixed meal tolerance test

    Measured: Baseline, 6 months postoperatively

  11. Change in insulin sensitivity (IS), measured by fasting blood insulin levels

    Fasting insulin levels are measured. IS is defined as 1/fasting insulin

    Measured: Baseline, 3 months postoperatively

  12. Change in percent fat free mass (FFM), measured by whole body dual-energy X-ray absorptiometry (DXA)

    Percent FFM is calculated as (1-Percent Fat Mass) from DXA

    Measured: Baseline, 3 months postoperatively

  13. Change in resting metabolic rate (RMR), measured by canopy indirect calorimetry

    RMR from canopy indirect calorimetry

    Measured: Baseline, 3 months postoperatively

  14. Change in 24 hour systolic blood pressure (BP), measured by ambulatory BP monitor

    Mean 24 hour systolic BP

    Measured: Baseline, 3 months postoperatively

  15. Change in indexed left ventricular mass (g/m to the 2.7th power), measured by echocardiogram

    Resting supine 2-dimensional echocardiogram

    Measured: Baseline, 3 months postoperatively

  16. Intervention Phase: Eligibility rate

    (Patients meeting inclusion and exclusion criteria/Total patients screened)*100

    Measured: Up to 150 weeks

  17. Intervention Phase: Enrollment rate

    (Participants enrolled/Patients eligible)*100

    Measured: Up to 154 weeks

  18. Intervention Phase: Retention rate

    (Participants completing all intervention visits/Patients enrolled)*100

    Measured: Up to 184 weeks

  19. Intervention Phase: Mean maximum tolerated semaglutide dose or tirzepatide dose

    Mean maximum tolerated dose (mg) of weekly injectable semaglutide or tirzepatide

    Measured: Baseline, 26 weeks

  20. Intervention Phase: Number of participants with at least one serious adverse event (AE) in the active medication group, measured by a count

    Individual participants with serious AEs will be counted

    Measured: Up to 30 weeks

  21. Intervention Phase: Number of participants with an adverse event (AE) that leads to discontinuation of the medication, measured by a count

    Participants experiencing an AE that leads to medication discontinuation will be counted

    Measured: Up to 30 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2024
  2. Study start11 Oct 2024
  3. Primary completion1 Sep 2027 (estimated)
  4. Study completion1 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06575738
Sponsor's protocol ID
21-3604
Other IDs
5K23HL163480-02
Acronym
PRESSURE
Status last verified
Jul 2026
First submitted
16 Aug 2024
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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