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Evaluation of Glucagon-Like Peptide-1 Receptor Agonist on Pathophysiology of Inflammation and Atherosclerosis in Persons Living With HIV: A Multicenter Randomized Placebo-Controlled Tri

Award Number: R01HL184987
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/10/2026
PERIOD OF PERFORMANCE END DATE: 03/31/2031

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Evaluation of Glucagon-Like Peptide-1 Receptor Agonist on Pathophysiology of Inflammation and Atherosclerosis in Persons Living With HIV: A Multicenter Randomized Placebo-Controlled Tri - Project Summary People living with HIV (PWH) have a higher risk of myocardial infarction and are twice as likely to develop cardiovascular disease accounting for a significant global burden of disease. While the mechanism underlying this excess risk is multifactorial, studies demonstrate that atherosclerosis in the setting of HIV is distinct and characterized by heightened arterial inflammation. Glucagon-like peptide-1 receptor agonist (GLP1-RA) using semaglutide is associated with reductions in major adverse cardiovascular events along with improvements in blood pressure, weight, and inflammatory markers in the general population with or without diabetes. While the precise mechanism by which GLP1-RA improves cardiovascular events remains unknown, GLP1-RA lowers production of inflammatory cytokines including IL-6, IL-1B, TNF-alpha and CRP as well as reduces macrophage infiltration in blood vessels and tissues. Among PWH, our team showed that semaglutide was safely tolerated and improved cardiometabolic indices and liver disease; however, the impact of this approach on atherosclerosis in HIV has not been evaluated. Given the key role of monocytes/ macrophages and inflammation in HIV- associated cardiovascular disease (CVD), the purpose of this proof- of-concept mechanistic trial is to evaluate the impact of GLP1-RA using semaglutide on the biology of HIV- associated atherosclerosis. We will perform a randomized placebo-controlled study of 125 treated and suppressed PWH aged 40 years and older with either known CVD or 1 risk factor for CVD to study the effect of GLP1-RA using oral semaglutide at 7mg once daily on arterial inflammation (assessed by FDG-PET/CT), biomarkers of inflammatory/immune activation, non-calcified plaque, and coronary inflammation in the coronary arteries (assessed by coronary computed tomography angiography, CCTA). This multicenter trial will include PWH enrolled at UCLA, UTHealth Houston, and Mass General Brigham (MGB) which are all sites with extensive experience in performing trials among PWH. Long time collaborators at MGB will serve as the core facility for the imaging endpoints. We have 3 specific aims for the Evaluation Of Glucagon-Like Peptide-1 Receptor Agonist on PathophysiologY of InflaMmation and Atherosclerosis in Persons Living With HIV: A Multicenter Randomized Placebo-Controlled Trial (Olympic- HIV Trial): Aim 1: To determine whether GLP1-RA using semaglutide can reduce arterial inflammation as assessed by FDG-PET/CT. We will also assess the impact of GLP1-RA on hematopoietic tissues; Aim 2: To determine the effect of GLP1-RA using semaglutide on markers of inflammation/immune activation and cardiometabolic indices (weight, adipose tissue measurements, lipids and HOMA-IR); Aim 3: To explore the impact of GLP1-RA on non-calcified coronary plaque (NCP) volume as measured by CCTA and coronary inflammation using pericoronary adipose tissue density(PCAT). These results will provide much needed data for the purpose of informing a larger clinical outcomes study in PWH.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $1,282,827 )
2026	2026	UNIVERSITY OF CALIFORNIA, LOS ANGELES	10889 WILSHIRE BLVD STE 700	LOS ANGELES	CA	90024	LOS ANGELES	USA	Cardiovascular Diseases Research	000	1	7/7/2026	NEW	$1,282,827
														Subtotal = $1,282,827

Grand Total All Awards = $1,282,827

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Evaluation of Glucagon-Like Peptide-1 Receptor Agonist on Pathophysiology of Inflammation and Atherosclerosis in Persons Living With HIV: A Multicenter Randomized Placebo-Controlled Tri

Award Number: R01HL184987

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/10/2026

PERIOD OF PERFORMANCE END DATE: 03/31/2031

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