Anti-obesity Pharmacotherapy and Inflammation

Louisiana State University

Status: Active, not recruiting

Conditions: Obesity

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

Study type: Observational

Funder types: Other

Identifiers

NCT05756764

U24DK132740-5053

U24DK132740 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 35 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Patients with obesity on pharmacotherapy

Description:

Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication

Treatment:

Drug: Naltrexone/Bupropion

Drug: Tirzepatide

Drug: Phentermine

Drug: Phentermine-Topiramate combination

Drug: Topiramate

Drug: Liraglutide

Drug: Diethylpropion

Drug: Semaglutide