Anti-obesity Pharmacotherapy and Inflammation

Active, not recruiting

• Conditions: Obesity
• Interventions: Drug: Semaglutide; Drug: Phentermine-Topiramate combination; Drug: Phentermine; Drug: Tirzepatide; Drug: Topiramate; Drug: Diethylpropion; Drug: Naltrexone/Bupropion; Drug: Liraglutide

• Registration Number: NCT05756764
• Lead Sponsor: Louisiana State University Health Sciences Center in New Orleans

Brief Summary

This study evaluates the relationship between weight loss, circulating inflammatory markers and lipids from 24 patients before and after 6 months of pharmacotherapy as a standard of care for anti-obesity treatment

Detailed Description

This study aims to determine if weight loss by pharmacotherapy with liraglutide, semaglutide, or phentermine-topiramate promotes the reduction of pro-tumoral inflammatory cells Myeloid-derived suppressor cells (MDSC), simultaneously to the improvement of lipid profile (LDL-Cholesterol, HDL-Cholesterol, triglycerides, and free fatty acids) and concentration in the blood.

Liraglutide, semaglutide, and phentermine-topiramate are FDA-approved medications to treat obesity and obesity-associated comorbidities.

Twenty-four patients undergoing standard of care for anti-obesity treatment at VA Medical Center, and Tulane Center for Clinical Research (TCCR) will be recruited before initiation of pharmacotherapy as part of their standard of care and followed up to 6 months to compare the primary study variables.

Study Timeline

• Study First Submitted: 2023-02-23
• Study First Submitted QC: 2023-03-03
• Study First Posted: 2023-03-06
• Study Start: 2023-06-01
• Status Verified: 2024-03
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Body mass index (BMI): over 30 kg/m2
• Age: 35 to 60 years old

Exclusion Criteria

• Taking medications with anti-inflammatory properties like glucocorticoids, prednisone, or non-steroidal anti-inflammatory medications, such as aspirin or Motrin Subjects on medications for long-term weight management such as phentermine-topiramate (Qsymia), orlistat (Xenical), naltrexone-bupropion (Contrave), and the glucagon-like peptide-1 receptor agonists such as liraglutide (Saxenda), and semaglutide (Wegovy).
• Prior history of cancer
• Having any clinical symptoms of systemic inflammation, acute infections such as Coronavirus disease 2019, or chronic diseases such as cancer, tuberculosis, autoimmune disease, and AIDS
• An adult unable to consent
• Prisoner
• Pregnancy or breastfeeding women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with obesity on pharmacotherapy	Phentermine-Topiramate combination	Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Patients with obesity on pharmacotherapy	Naltrexone/Bupropion	Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Patients with obesity on pharmacotherapy	Semaglutide	Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Patients with obesity on pharmacotherapy	Phentermine	Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Patients with obesity on pharmacotherapy	Tirzepatide	Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Patients with obesity on pharmacotherapy	Topiramate	Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Patients with obesity on pharmacotherapy	Diethylpropion	Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Patients with obesity on pharmacotherapy	Liraglutide	Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication

Primary Outcome Measures

Name	Time	Method
MDSC in peripheral blood	baseline and 24 weeks	Changes in number of MDSC in blood
weight loss	baseline and 24 weeks	Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)
Levels of lipids in circulation	baseline and 24 weeks	Changes in concentration (mg/dL) of each type of lipids: LDL-Cholesterol, triglycerides, and free fatty acids

Secondary Outcome Measures

Name	Time	Method
Systemic inflammation measured by C-reactive protein levels	baseline and 24 weeks	Changes in concentration (mg/L) of C-reactive protein in serum
Systemic inflammation measured by adipokines levels in circulation	baseline and 24 weeks	Changes in concentration (pg/mL) of interleukin 6 (IL-6), tumor-necrosis factor alpha (TNFa) and leptin in plasma

Trial Locations

Locations (2)

LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO; 🇺🇸 New Orleans, Louisiana, United States

Ochsner Health System - Biospecimen; 🇺🇸 New Orleans, Louisiana, United States