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Active not recruiting

Anti-obesity Pharmacotherapy and Inflammation

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

Assets

GLP-1 / incretin class catch-all / Liraglutide / Semaglutide / Tirzepatide

Listed sites

2

Recruiting sites

Enrollment

30

estimated

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoints

Body weight, % changeMDSC in peripheral bloodLevels of lipids in circulation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05756764
Org study IDU24DK132740-5053
Secondary IDU24DK132740

Timeline

Milestones

Study first posted2023-03-06actual
Study start2023-06-01actual
Last update posted2025-09-09actual
Primary completion2026-01-30estimated
Study completion2026-02-20estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age35 Years
Maximum age60 Years
SexAll
Sampling methodProbability sample

Study population text

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.

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Cardiometabolic biomarkers
3
Weight & body composition
1
Other (unclassified)
1

Weight & body composition

1 endpoint
Primary/protocol endpoint

weight loss

Time frame:baseline and 24 weeks

Body weight, % change

percent change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints
Primary/protocol endpoint

Levels of lipids in circulation

Time frame:baseline and 24 weeks

change from baseline, improvement

Secondary/protocol endpoint

Systemic inflammation measured by C-reactive protein levels

Time frame:baseline and 24 weeks

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Secondary/protocol endpoint

Systemic inflammation measured by adipokines levels in circulation

Time frame:baseline and 24 weeks

Leptin, change

change from baseline, improvement

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

MDSC in peripheral blood

Time frame:baseline and 24 weeks

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.