Recruiting
Phase 2

Bempedoic Acid

Sponsor:

Priscilla Hsue, MD

Code:

NCT05488431

Conditions

Dyslipidemias

Cardiovascular Diseases

HIV Infections

Atherosclerosis

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

Bempedoic acid

Placebo

Study Details

Brief summary:

This is a randomized placebo-controlled study in treated and suppressed HIV-infected individuals aged ≥40 years with either known CVD or 1 CVD risk factor to study the effect of Bempedoic acid (BA) on safety, arterial inflammation as assessed by FDG-PET/CT, lipids, inflammation, immune activation, cardiometabolic indices, and non-calcified plaque (NCP) in the coronary arteries (assessed by coronary CT angiography, CCTA). This trial will be enrolled at UCSF and UCLA. Collaborators at Massachusetts General Hospital (MGH) will serve as the core facility for imaging.

Conditions

Dyslipidemias

Cardiovascular Diseases

HIV Infections

Atherosclerosis

Study ID

NCT05488431

Start date

Mar 1, 2023

Status verified date

Dec, 2025

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Documented HIV infection
  • On continuous antiretroviral therapy and virologically suppressed HIV infection for ≥12 weeks prior to study entry
  • CD4 T-cell count ≥ 200 cells/mm3
  • Male or female between the ages ≥ 40 years of age
  • LDL-C ≥ 50 mg/dL
  • Documented cardiovascular disease as defined by: 1. Prior myocardial infarction, 2. Prior cerebrovascular disease, 3. Prior peripheral arterial disease, 4. History of percutaneous coronary intervention, 5. History of coronary artery bypass graft OR 6. Angiographic evidence of >50% stenosis in at least one coronary artery\] OR 1 CVD risk factor (T2DM, current smoking, hypertension, dyslipidemia, hsCRP≥2mg/L, family history)
  • TBR of >1.6 of the MDS of the carotid/aorta at baseline. This baseline arterial TBR cutoff excludes the rare individual that lacks appreciable arterial inflammation. It is notable that while 5-10% of uninfected individuals will have lower TBRs, it is rare that an HIV infected individual will fall below this range.
  • Female subjects must either be of non-childbearing potential (defined as post-menopausal or amenorrhea > 12 months) or agree to use two forms of contraception (one hormonal and one barrier) throughout the study and for at least one month following study completion and have a negative pregnancy test at screening and prior to the first dose of drug.
  • Males must use at least one method of contraception throughout the study.

Exclusion Criteria:

  • Pregnant/nursing women (as there is no data on bempedoic acid in this setting)
  • Diabetes requiring insulin (as insulin treatment alters the uptake of 18FDG)
  • Uncontrolled HTN as defined by baseline blood pressure reading of ≥160 mmHg systolic OR ≥100 mmHg diastolic (exclusion criteria in other studies with BA)
  • AST/ALT or alkaline phosphatase >2x ULN
  • Triglycerides >500 mg/dL at screening
  • Cancer within the last 5 years with exception of squamous cell carcinoma and basal cell carcinoma
  • Individuals on simvastatin >20mg or pravastatin >40mg. All other dosages and statins will be permitted with close monitoring for myopathies including assessment of CK levels
  • Nephrotic syndrome or eGFR <30 mL/min/1.73m2
  • Cytopenias which include 1) WBC <3.5 x103/uL 2) Platelet <120 x103/uL 3) ANC <1.5 x103/uL, and absolute lymphocytes <0.8 x 103/uL
  • Anemia as fined by Hgb <10 g/dL
  • Acute systemic infection within 30 days

Study Design

Enrollment

121 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Bempedoic acid (BA)

Patients randomized into the BA arm will receive 180 mg BA administered orally once daily without food for 52 weeks.

placebo comparator: Placebo

Patients randomized into the placebo arm will receive 180 mg placebo administered orally once daily without food for 52 weeks.

Interventions

Bempedoic acid

Bempedoic Acid is an oral first-in-class small molecular adenosine triphosphate (ATP)-citrate lyase (ACL) inhibitor which lowers LDL-C by inhibition of cholesterol synthesis in the liver. ACL is an enzyme upstream of 3-hydroxy-3-methyl-glutaryl-coenzyme A (HMG-CoA) reductase in the cholesterol biosynthesis pathway. Inhibition of ACL by bempedoyl-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of LDL receptors and concomitant suppression of hepatic fatty acid biosynthesis. BA has been studied in >4300 individuals and is currently being studied in >14,000 individuals in CLEAR Outcomes (NCT02993406).

Placebo

Placebo

Primary outcome measure

  • FDG PET/CT Endpoint [ Time Frame: Baseline and Week 52 ]

Central Contacts and Locations

Central contacts

Marta Levkova

628-206-8037marta.levkova@ucsf.edu

Locations

UCLA Center for Clinical AIDS Research and Education (CARE)

Recruiting

Los Angeles, California, United States, 90095

Contacts

Aleen Khodabakhshian

(310) 557-3798akhodabakhshian@mednet.ucla.edu

Principal Investigator:

Priscilla Hsue, MD

San Francisco General Hospital

Recruiting

San Francisco, California, United States, 94110

Contacts

Marta Levkova

628-206-8037Marta.levkova@ucsf.edu

Principal Investigator:

Priscilla Hsue, MD

UT Health Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Brenda Lastra Bojorguez

brenda.lastrabojorquez@uth.tmc.edu

Principal Investigator:

Jordan Lake, MD

More Information

Sponsor

Priscilla Hsue, MD

Last update posted

Dec 17, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Priscilla Hsue, MD on 2025-12-17.