ObesityNCT05756764
Anti-obesity Pharmacotherapy and Inflammation
An observational study of Obesity, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Semaglutide, Phentermine-Topiramate combination and Phentermine
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2023to 20 Feb 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Adult
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.
Who may be able to join
- Body mass index (BMI): over 30 kg/m2
- Age: 35 to 60 years old
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
United States2 sites
LSU Clinical & Translational Research Center (CTRC - - LSUHSC-NO
New Orleans, Louisiana, 70112
Ochsner Health System - Biospecimen
New Orleans, Louisiana, 70121
About this study
Official title: 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
Read the 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.
- Conditions
- Obesity
- Being tested
- Semaglutide, Phentermine-Topiramate combination, Phentermine, Tirzepatide, Topiramate
- Keywords
- Inflammation, Dyslipidemia, Metabolic syndrome
- Medical subject headings
- Obesity, Inflammation, Dyslipidemias, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Also called Glucagon-like peptide-1 receptor (GLP1-R) agonist, Wegovy
Medication for weight loss
Phentermine-Topiramate combinationDrug
Also called Qsymia
Medication for weight loss
PhentermineDrug
Also called Lomaira, Adipex-P
Medication for weight loss
TirzepatideDrug
Also called Mounjaro, Zepbound, GIP/GLP-1 RA
Medication for weight loss
TopiramateDrug
Also called Topamax, Trokendi XR, Qudexy XR
Medication for weight loss
DiethylpropionDrug
Also called Tenuate, Diethylcathinone
Medication for weight loss
Naltrexone/BupropionDrug
Also called Contrave
Medication for weight loss
LiraglutideDrug
Also called Saxenda, Victoza, Glucagon-like peptide-1 receptor (GLP1-R) agonist
Medication for weight loss
| Study group | Role | What they receive |
|---|---|---|
| Patients with obesity on pharmacotherapy | Before initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication Receives: Drug: Semaglutide; Drug: Phentermine-Topiramate combination; Drug: Phentermine; Drug: Tirzepatide; Drug: Topiramate; Drug: Diethylpropion; Drug: Naltrexone/Bupropion; Drug: Liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Weight Loss Percentage (Pounds lost divided by starting weight (in pounds) multiplied by 100)
Measured: baseline and 24 weeks
MDSC in peripheral blood
Changes in number of MDSC in blood
Measured: 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
Measured: baseline and 24 weeks
Secondary outcomes (2)
Systemic inflammation measured by C-reactive protein levels
Changes in concentration (mg/L) of C-reactive protein in serum
Measured: baseline and 24 weeks
Systemic inflammation measured by adipokines levels in circulation
Changes in concentration (pg/mL) of interleukin 6 (IL-6), tumor-necrosis factor alpha (TNFa) and leptin in plasma
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start1 Jun 2023
- Primary completion30 Jan 2026 (estimated)
- Study completion20 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louisiana State University Health Sciences Center in New Orleans
- Sponsor type
- University, hospital or other
- Collaborators
- Tulane University, Pennington Biomedical Research Center, Ochsner Health System
- Responsible party
- Principal investigator, Maria Sanchez-Pino, Ph.D., Louisiana State University Health Sciences Center in New Orleans
- Investigators
- Maria D Sanchez-Pino, Ph.D., Principal investigator, LSU-Health Sciences Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756764
- Sponsor's protocol ID
- U24DK132740-5053
- Other IDs
- U24DK132740
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2023
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Effect of Weight Loss by Pharmacotherapy on Chronic Pro-tumor Inflammatory Cells
- ClinicalTrials.gov ID
- NCT05756764
- Acronym / sponsor ID
- U24DK132740-5053
- Conditions
- Obesity
- Keywords
- Inflammation, Dyslipidemia, Metabolic syndrome
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Louisiana State University Health Sciences Center in New OrleansUniversity, hospital or other
- Collaborators
- Tulane University, Pennington Biomedical Research Center, Ochsner Health System
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 20 Feb 2026 (estimated)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with obesity on pharmacotherapy | – | Drug: Semaglutide, Drug: Phentermine-Topiramate combination, Drug: Phentermine, Drug: Tirzepatide, Drug: Topiramate, Drug: Diethylpropion, Drug: Naltrexone/Bupropion, Drug: LiraglutideBefore initiation of pharmacotherapy (as part of the standard-of-care treatment) and 6 months after initiated medication |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Body mass index (BMI): over 30 kg/m2
- Age: 35 to 60 years old
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideAlso: Glucagon-like peptide-1 receptor (GLP1-R) agonist, WegovyMedication for weight loss | Drug | Patients with obesity on pharmacotherapy |
| Phentermine-Topiramate combinationAlso: QsymiaMedication for weight loss | Drug | Patients with obesity on pharmacotherapy |
| PhentermineAlso: Lomaira, Adipex-PMedication for weight loss | Drug | Patients with obesity on pharmacotherapy |
| TirzepatideAlso: Mounjaro, Zepbound, GIP/GLP-1 RAMedication for weight loss | Drug | Patients with obesity on pharmacotherapy |
| TopiramateAlso: Topamax, Trokendi XR, Qudexy XRMedication for weight loss | Drug | Patients with obesity on pharmacotherapy |
| DiethylpropionAlso: Tenuate, DiethylcathinoneMedication for weight loss | Drug | Patients with obesity on pharmacotherapy |
| Naltrexone/BupropionAlso: ContraveMedication for weight loss | Drug | Patients with obesity on pharmacotherapy |
| LiraglutideAlso: Saxenda, Victoza, Glucagon-like peptide-1 receptor (GLP1-R) agonistMedication for weight loss | Drug | Patients with obesity on pharmacotherapy |
Primary outcome
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
2 secondary outcomes
Systemic inflammation measured by C-reactive protein levels
Time frame: baseline and 24 weeks
Systemic inflammation measured by adipokines levels in circulation
Time frame: baseline and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria D Sanchez-Pino, Ph.D. principal investigator
LSU-Health Sciences Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Louisiana State University Health Sciences Center in New Orleans at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: baseline and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.