Anti-obesity Pharmacotherapy and Inflammation

NCT05756764 | Active Not Recruiting DMC FDA Drug

• 2 other identifiers: U24DK132740-5053U24DK132740
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 2

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

Conditions

Obesity

Keywords

Inflammation; Dyslipidemia; Metabolic syndrome

Outcome Measures

Primary Outcomes (3)

• weight loss

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

  baseline and 24 weeks

• MDSC in peripheral blood

  Changes in number of MDSC in blood

  baseline and 24 weeks

• Levels of lipids in circulation

  Changes in concentration (mg/dL) of each type of lipids: LDL-Cholesterol, triglycerides, and free fatty acids

  baseline and 24 weeks

Secondary Outcomes (2)

• Systemic inflammation measured by C-reactive protein levels

  baseline and 24 weeks

• Systemic inflammation measured by adipokines levels in circulation

  baseline and 24 weeks

Study Arms (1)

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; Drug: Phentermine-Topiramate combination; Drug: Phentermine; Drug: Tirzepatide; Drug: Topiramate; Drug: Diethylpropion; Drug: Naltrexone/Bupropion; Drug: Liraglutide

Interventions

Semaglutide DRUG

Medication for weight loss

Also known as: Glucagon-like peptide-1 receptor (GLP1-R) agonist, Wegovy

Patients with obesity on pharmacotherapy

Phentermine-Topiramate combination DRUG

Medication for weight loss

Also known as: Qsymia

Patients with obesity on pharmacotherapy

Phentermine DRUG

Medication for weight loss

Also known as: Lomaira, Adipex-P

Patients with obesity on pharmacotherapy

Tirzepatide DRUG

Medication for weight loss

Also known as: Mounjaro, Zepbound, GIP/GLP-1 RA

Patients with obesity on pharmacotherapy

Topiramate DRUG

Medication for weight loss

Also known as: Topamax, Trokendi XR, Qudexy XR

Patients with obesity on pharmacotherapy

Diethylpropion DRUG

Medication for weight loss

Also known as: Tenuate, Diethylcathinone

Patients with obesity on pharmacotherapy

Naltrexone/Bupropion DRUG

Medication for weight loss

Also known as: Contrave

Patients with obesity on pharmacotherapy

Liraglutide DRUG

Medication for weight loss

Also known as: Saxenda, Victoza, Glucagon-like peptide-1 receptor (GLP1-R) agonist

Patients with obesity on pharmacotherapy

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Louisiana State University Health Sciences Center in New Orleans: lead
• Tulane University: collaborator
• Pennington Biomedical Research Center: collaborator
• Ochsner Health System: collaborator

Study Sites (2)

LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO

New Orleans, Louisiana, 70112, United States

Location

Ochsner Health System - Biospecimen

New Orleans, Louisiana, 70121, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be obtained from participant subjects. Collection of serum, plasma, and isolation of leukocytes will be used for study aims and storage (-80 degrees).

MeSH Terms

Conditions

Obesity; Inflammation; Dyslipidemias; Metabolic Syndrome

Interventions

semaglutide; Glucagon-Like Peptide-1 Receptor; Qsymia; Phentermine; Tirzepatide; Topiramate; Diethylpropion; Naltrexone; Bupropion; bupropion hydrochloride, naltrexone hydrochoride drug combination; Liraglutide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Lipid Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Propiophenones; Ketones; Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Maria D Sanchez-Pino, Ph.D.

  LSU-Health Sciences Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 6, 2023
• Study Start: June 1, 2023
• Primary Completion: January 30, 2026
• Study Completion: February 20, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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)

Locations

US (2)