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Bariatric Surgery + Semaglutide for Obesity (PRESSURE Trial)

Phase 1

Recruiting

Led By Jaime Moore, MD MPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Obesity: age 12-17 years: BMI ≥95th%ile for age/sex | age 18-24 years: BMI ≥ 30kg/m^2

Male or female biological sex, age 12 through 24 years

Must not have

Surgically correctable cause of suboptimal postoperative weight loss

Hypothalamic Obesity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 12 months postoperatively

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand the effects of bariatric surgery on teenagers and young adults aged 12 to 24. The study wants to figure out why some people respond differently to this surgery and what

Who is the study for?

This trial is for young individuals aged 12 to 24 who have undergone bariatric surgery but haven't lost as much weight as expected within 1-2 years post-operation. It's important that participants are in the age range and at a certain stage after their surgery.

What is being tested?

The study is examining how adolescents' bodies respond to bariatric surgery and if adding semaglutide, an injectable medication, can improve outcomes for those not meeting weight loss expectations post-surgery.

What are the potential side effects?

While specific side effects aren't listed here, semaglutide may commonly cause digestive issues like nausea or constipation, potential low blood sugar levels, and possible injection site reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a teen with a BMI in the top 5% for my age/sex or an adult with a BMI of 30 or more.

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I am between 12 and 24 years old.

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I have had a vertical sleeve gastrectomy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition that can be fixed with surgery to improve weight loss after surgery.

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I have obesity caused by a brain condition.

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I have Type 2 Diabetes.

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I have a heart condition that worsens with a faster heartbeat.

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I do not have severe, unmanaged depression.

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I am scheduled for Roux-en-Y gastric bypass surgery.

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I have obesity caused by a brain condition.

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I have Type 2 Diabetes.

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I have not taken insulin secretagogues recently.

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I am currently using insulin.

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I have a history of multiple endocrine neoplasia type 2.

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I have had pancreatitis before.

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My high blood pressure is not under control.

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I or someone in my family has had medullary thyroid cancer.

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I have had cancer within the last 5 years.

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I have a thyroid condition that hasn't been treated.

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My physical development is at the earliest puberty stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 12 months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 12 months postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intervention phase: Change in BMI

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

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

+5 more

Secondary study objectives

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

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

Change in fasting ghrelin, measured by blood levels

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Active Medication + Usual Postoperative CareExperimental Treatment2 Interventions

Participants can be enrolled between 1 and 2 years postoperatively and will receive usual interdisciplinary postoperative care plus weekly subcutaneous injectable semaglutide for 26 weeks. Initial dose is 0.25mg and is escalated every 4 weeks as tolerated (0.5mg, 1.0mg, 1.7mg, 2.4mg) for a total exposure of 26 weeks.

Group II: ObservationalActive Control1 Intervention

Participants complete a set of standardized measures before bariatric surgery, 3 months postoperatively, and 12 months postoperatively.

Group III: Usual Postoperative CareActive Control1 Intervention

Participants can be enrolled between 1 and 2 years postoperatively and will receive usual interdisciplinary postoperative care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Usual postoperative care

2019

N/A

~27510