DRUG
Semaglutide
Medication for weight loss
Anti-obesity Pharmacotherapy and Inflammation
Status
Active, not recruiting
Phase
Not applicable
Enrollment
30
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Full 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.
Interventions
Treatment arms and agents.
DRUG
Phentermine-Topiramate combination
Medication for weight loss
DRUG
Phentermine
Medication for weight loss
DRUG
Tirzepatide
Medication for weight loss
DRUG
Topiramate
Medication for weight loss
DRUG
Diethylpropion
Medication for weight loss
DRUG
Naltrexone/Bupropion
Medication for weight loss
DRUG
Liraglutide
Medication for weight loss
Timeline
From registration to results.
First posted
Mar 6, 2023
Study start
Jun 1, 2023
Primary completion
Jan 30, 2026
Study completion
Feb 20, 2026
Results posted
Not reported
Registry updated
Sep 9, 2025
Outcomes
What the study measures.
Primary outcomes
weight loss
Time frame · baseline and 24 weeks
Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)
MDSC in peripheral blood
Time frame · baseline and 24 weeks
Changes in number of MDSC in blood
Levels of lipids in circulation
Time frame · baseline and 24 weeks
Changes in concentration (mg/dL) of each type of lipids: LDL-Cholesterol, triglycerides, and free fatty acids
Secondary outcomes
Systemic inflammation measured by C-reactive protein levels
Time frame · baseline and 24 weeks
Changes in concentration (mg/L) of C-reactive protein in serum
Systemic inflammation measured by adipokines levels in circulation
Time frame · baseline and 24 weeks
Changes in concentration (pg/mL) of interleukin 6 (IL-6), tumor-necrosis factor alpha (TNFa) and leptin in plasma
Eligibility
Who can take part.
- Minimum age
- 35 Years
- Maximum age
- 60 Years
- Sex
- ALL
- Healthy volunteers
- Not reported
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 locations
2 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO
New Orleans, Louisiana, United States
Ochsner Health System - Biospecimen
New Orleans, Louisiana, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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