Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05756764

Anti-obesity Pharmacotherapy and Inflammation

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semaglutide

Drug

Medication for weight loss

Other names: Glucagon-like peptide-1 receptor (GLP1-R) agonist, Wegovy

Phentermine-Topiramate combination

Drug

Medication for weight loss

Other names: Qsymia

Phentermine

Drug

Medication for weight loss

Other names: Lomaira, Adipex-P

Tirzepatide

Drug

Medication for weight loss

Other names: Mounjaro, Zepbound, GIP/GLP-1 RA

Topiramate

Drug

Medication for weight loss

Other names: Topamax, Trokendi XR, Qudexy XR

Diethylpropion

Drug

Medication for weight loss

Other names: Tenuate, Diethylcathinone

Naltrexone/Bupropion

Drug

Medication for weight loss

Other names: Contrave

liraglutide

Drug

Medication for weight loss

Other names: Saxenda, Victoza, Glucagon-like peptide-1 receptor (GLP1-R) agonist

Primary outcomes

  1. weight loss

    Time frame: baseline and 24 weeks

    Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)

  2. MDSC in peripheral blood

    Time frame: baseline and 24 weeks

    Changes in number of MDSC in blood

  3. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Louisiana State University Health Sciences Center in New Orleans

Other

Collaborators

  • Ochsner Health System
  • Pennington Biomedical Research Center
  • Tulane University

Registry information

Official study title

Pilot Study of the Effect of Weight Loss by Pharmacotherapy on Chronic Pro-tumor Inflammatory Cells

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.