Bariatric Surgery + Semaglutide for Obesity

(PRESSURE Trial)

Recruiting at 1 trial location

Overseen By Jaime Moore, MD MPH

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Colorado, Denver

Must not be taking: Glucocorticoids, Insulin, Metformin, others

Disqualifiers: Diabetes, Hypertension, Heart disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

48 Participants Needed

Trial Summary

What is the purpose of this 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) 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.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications before participating. You cannot use oral glucocorticoids, insulin, metformin, insulin secretagogues, or anti-obesity medications close to the start of the study. If you are on medications for hypertension, dyslipidemia, depression, or anxiety, they should not have been changed within 4 weeks prior to enrollment.

What data supports the effectiveness of the drug Semaglutide for obesity?

Semaglutide has been shown to help people lose about 15% of their initial weight over 68 weeks, making it one of the most effective obesity medications available. It also improves heart health and physical functioning, providing more options for weight management. ^{1 2 3 4 5}

How does the treatment of bariatric surgery combined with semaglutide differ from other obesity treatments?

This treatment is unique because it combines bariatric surgery, which is a surgical procedure to help with weight loss, with semaglutide, a once-weekly injection that has shown significant weight loss results. Semaglutide is considered a 'game changer' for obesity management due to its ability to achieve substantial and sustained weight loss, which is greater than what is typically achieved with other medications. ^{1 3 6 7 8}

Research Team

Jaime Moore, MD MPH

Principal Investigator

University of Colorado, Denver

Eligibility Criteria

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.

Inclusion Criteria

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.

Signed and dated informed consent form

I am willing and able to follow all study requirements.

Exclusion Criteria

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

I have obesity caused by a brain condition.

Baseline alanine transaminase (ALT) or aspartate aminotransferase (AST) ≥ 5x upper limit of normal

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Observational

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

12 months

3 visits (in-person)

Intervention

Participants receive usual interdisciplinary postoperative care plus weekly subcutaneous injectable semaglutide for 26 weeks

26 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Semaglutide

Trial Overview 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.

Participant Groups

Group I: Active Medication + Standard Postoperative Care Experimental Treatment 2 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: Observational Active Control 1 Intervention

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

Group III: Standard Postoperative Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Findings from Research

Semaglutide, a glucagon-like peptide-1 receptor agonist, has been shown to produce the largest weight loss of any obesity medication, with an average reduction of about 15% of initial body weight over 68 weeks.

In addition to significant weight loss, semaglutide also improves cardiovascular risk factors and physical functioning, making it a promising option for chronic weight management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. Chao, AM., Tronieri, JS., Amaro, A., et al.[2023]

In a study of 20 patients with type 2 diabetes in Slovenia, oral semaglutide significantly reduced HbA1c levels and fasting plasma glucose, indicating its efficacy in improving glycaemic control.

Patients reported high satisfaction with the treatment, and while some experienced mild gastrointestinal side effects, the overall safety profile was considered good, suggesting that oral semaglutide is a promising option for diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. Janić, M., Jovanović, M., Janež, A., et al.[2023]

Semaglutide (Ozempic®) is an effective once-weekly treatment for type 2 diabetes, showing superior glucose-lowering effects and greater weight loss compared to other GLP-1 receptor agonists in Phase III clinical trials.

It is approved for use in Belgium for patients with type 2 diabetes who have not achieved adequate control with other antidiabetic therapies, particularly in those with a body mass index of 30 kg/m² or higher.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. Scheen, AJ.[2019]

Oral semaglutide (Rybelsus®) has been shown to provide better glycaemic control and promote weight loss in patients with type 2 diabetes (T2DM) compared to standard oral glucose-lowering medications, based on data from the PIONEER clinical trial program involving 9543 patients.

The safety profile of oral semaglutide is similar to other GLP-1 receptor agonists, and it demonstrated cardiovascular safety comparable to placebo in high-risk patients, making it a viable option for T2DM management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. Paquot, N.[2022]

Semaglutide, a glucagon-like peptide-1 receptor agonist, is effective for treating type 2 diabetes and obesity, providing significant weight loss and cardiovascular benefits, making it crucial for high-risk patients.

However, during the SUSTAIN clinical trial program, a safety concern arose regarding the worsening of diabetic retinopathy, potentially linked to rapid reductions in HbA1c levels, which requires further investigation and careful clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide-eye-catching results. Cigrovski Berkovic, M., Strollo, F.[2023]

In a study of 129 patients with severe obesity (BMI ≥ 40 kg/m²), semaglutide 2.4 mg treatment led to a significant average weight loss of 9.1% over 24 weeks, showing its effectiveness in this population.

There was no significant difference in weight loss between patients who had previously undergone bariatric surgery and those who had not, indicating that semaglutide can be a viable treatment option for both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4 mg/wk for weight loss in patients with severe obesity and with or without a history of bariatric surgery. Bonnet, JB., Tournayre, S., Anitcheou, J., et al.[2023]

In a study of 44 non-diabetic patients who experienced weight regain or insufficient weight loss after bariatric surgery, adjunct treatment with the GLP-1 receptor agonist semaglutide resulted in significant weight loss of -6.0% after 3 months and -10.3% after 6 months, indicating its efficacy in managing post-bariatric weight issues.

The study suggests that semaglutide could be a beneficial treatment option for patients struggling with weight regain after surgery, but further research through prospective randomized controlled trials is needed to validate these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Semaglutide Once-Weekly in Patients Without Type 2 Diabetes with Weight Regain or Insufficient Weight Loss After Bariatric Surgery-a Retrospective Analysis. Lautenbach, A., Wernecke, M., Huber, TB., et al.[2022]

Semaglutide, a once-weekly glucagon-like peptide-1 receptor agonist, has been shown to achieve significant and sustained weight loss in individuals with obesity, surpassing results from previous weight-loss medications, and has been approved for use alongside diet and exercise.

Emerging treatments like tirzepatide and cagrilintide are demonstrating even greater weight loss effects than semaglutide, indicating a shift towards more effective 'weight-centric' strategies for managing obesity and related conditions like type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? Colin, IM., Gérard, KM.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of obesity. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy, safety, and patient satisfaction with oral semaglutide: first single-centre clinical experience. [2023]

3. Belgium pubmed.ncbi.nlm.nih.gov

[Semaglutide, once weekly GLP-1 receptor agonist (Ozempic®)]. [2019]

4. Belgium pubmed.ncbi.nlm.nih.gov

[Oral semaglutide, first oral GLP-1 receptor agonist (Rybelsus®)]. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Semaglutide-eye-catching results. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4 mg/wk for weight loss in patients with severe obesity and with or without a history of bariatric surgery. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The Potential of Semaglutide Once-Weekly in Patients Without Type 2 Diabetes with Weight Regain or Insufficient Weight Loss After Bariatric Surgery-a Retrospective Analysis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Once-weekly 2.4 mg Semaglutide for Weight Management in Obesity: A Game Changer? [2022]