DelfaGLP-1 Atlas

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PRESSURE

RecruitingPhase 1

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

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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

40

estimated

Study population

Bariatric Surgery, Bariatric Surgery Candidate, Obesity / overweight

Key I/E criterion

—

Primary endpoints

•Observational phase•HOMA-IR (insulin sensitivity)•Systolic BP, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06575738
Org study ID21-3604
Secondary ID5K23HL163480-02

Timeline

Milestones

Study first posted2024-08-28actual
Study start2024-10-11actual
Last update posted2026-01-12actual
Primary completion2027-09-01estimated
Study completion2027-10-01estimated

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Bariatric SurgeryBariatric Surgery CandidateObesity / overweight

Eligibility

Who can enroll

Minimum age12 Years
Maximum age24 Years
SexAll
Healthy volunteersNot accepted

Inclusion 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

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

Endpoints (29)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)
17
Cardiometabolic biomarkers
4
Weight & body composition
3
Safety / tolerability / PK
3
Glycemic / diabetes
2

Weight & body composition

3 endpoints
Primary/protocol endpoint

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

Time frame:Baseline, 12 months postoperatively

change from baseline, improvement

Primary/protocol endpoint

Intervention phase: Change in BMI

Time frame:Baseline, 26 weeks

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, 3 months postoperatively

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Primary/protocol endpoint

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

Time frame:Baseline, 12 months postoperatively

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, 3 months postoperatively

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Cardiometabolic biomarkers

4 endpoints
Primary/protocol endpoint

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

Time frame:Baseline, 12 months postoperatively

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 3 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint

Change in stimulated ghrelin, measured by blood levels

Time frame:Baseline, 12 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint

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

Time frame:Baseline, 3 months postoperatively

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Intervention Phase: Mean maximum tolerated semaglutide dose

Time frame:Baseline, 26 weeks

descriptive

Secondary/protocol endpoint

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

Time frame:Up to 30 weeks

Serious AEs (any)

event count, event

Secondary/protocol endpoint

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

Time frame:Up to 30 weeks

Discontinuation due to AE

event count, event

Other (unclassified)

17 endpoints
Primary/protocol endpoint/low confidence

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

Time frame:Baseline, 12 months postoperatively

change from baseline, descriptive

Primary/protocol endpoint/low confidence

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

Time frame:Baseline, 12 months postoperatively

change from baseline, improvement

Primary/protocol endpoint/low confidence

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

Time frame:Baseline, 12 months postoperatively

change from baseline, descriptive

Primary/protocol endpoint/low confidence

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

Time frame:Baseline, 12 months postoperatively

change from baseline, improvement

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 3 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 3 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 12 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 3 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 12 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in fasting ghrelin, measured by blood levels

Time frame:Baseline, 3 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in fasting ghrelin, measured by blood levels

Time frame:Baseline, 12 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in stimulated ghrelin, measured by blood levels

Time frame:Baseline, 3 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 3 months postoperatively

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

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

Time frame:Baseline, 3 months postoperatively

change from baseline, improvement

Secondary/protocol endpoint

Intervention Phase: Eligibility rate

Time frame:Up to 150 weeks

ratio, descriptive

Secondary/protocol endpoint

Intervention Phase: Enrollment rate

Time frame:Up to 154 weeks

ratio, descriptive

Secondary/protocol endpoint

Intervention Phase: Retention rate

Time frame:Up to 184 weeks

descriptive

Publications (10)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.