Anti-obesity Pharmacotherapy and Inflammation

September 2, 2025 updated by: Maria Sanchez-Pino, Ph.D., Louisiana State University Health Sciences Center in New Orleans

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / 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 Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Health System - Biospecimen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with obesity, defined as having a body mass index (BMI) > 30, from New Orleans and its surroundings, scheduled for initiating the anti-obesity treatment with drugs for weight loss as part of their standard-of-care for anti-obesity treatment at Clinics from New Orleans and its surroundings; therefore, the research trial team will not provide the medications. Expect to recruit 50% African American (6 women, 6 men), and 50% White American (6 women, 6 men), as a representative majority of the New Orleans population.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with obesity on pharmacotherapy
Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication
Drug: Semaglutide
Medication for weight loss
Other Names:
  • Wegovy
  • Glucagon-like peptide-1 receptor (GLP1-R) agonist
Drug: Phentermine-Topiramate combination
Medication for weight loss
Other Names:
  • Qsymia
Drug: Phentermine
Medication for weight loss
Other Names:
  • Lomaira
  • Adipex-P
Drug: Tirzepatide
Medication for weight loss
Other Names:
  • Mounjaro
  • Zepbound
  • GIP/GLP-1 RA
Drug: Topiramate
Medication for weight loss
Other Names:
  • Topamax
  • Trokendi XR
  • Qudexy XR
Drug: Diethylpropion
Medication for weight loss
Other Names:
  • Tenuate
  • Diethylcathinone
Drug: Naltrexone/Bupropion
Medication for weight loss
Other Names:
  • Contrave
Drug: Liraglutide
Medication for weight loss
Other Names:
  • Victoza
  • Saxenda
  • Glucagon-like peptide-1 receptor (GLP1-R) agonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight loss
Time Frame: baseline and 24 weeks
Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)
baseline and 24 weeks
MDSC in peripheral blood
Time Frame: baseline and 24 weeks
Changes in number of MDSC in blood
baseline and 24 weeks
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
baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline and 24 weeks
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
baseline and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Louisiana State University Health Sciences Center in New Orleans

Collaborators

Tulane University
Pennington Biomedical Research Center
Ochsner Health System

Investigators

  • Principal Investigator: Maria D Sanchez-Pino, Ph.D., LSU-Health Sciences Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

February 20, 2026

Study Registration Dates

First Submitted

February 23, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 2, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U24DK132740-5053
  • U24DK132740 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The investigators will adhere to the NIH Grants Policy on Sharing of Unique Research Resources, including the Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (NOT-OD-21-013).

Data dictionaries, statistical analysis code, and de-identified data may be deposited for sharing. Data may include demographic, clinical, anthropometric, outcome measures, and other relevant variables, as allowed by the data-owning organization, consistent with applicable laws and regulations.

IPD Sharing Time Frame

Data may be deposited into the repository no later than within one year of completing the study period for the award or upon acceptance of the data for publication or public disclosure of study results.

IPD Sharing Access Criteria

Deidentified data and supporting information may be shared with investigators and research staff working under a Federal Wide Assurance (FWA) institution and could be used for secondary study purposes after approval of the local Institutional Review Board (IRB)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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