Long-Term Cardiovascular Impact of ArmoLIPID Cholesterol Plus: An In Silico Study Using Digital Twins

NCT07892092 | Completed

• 1 other identifier: AETERNA-ARMOLIPID-001
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study, conducted entirely using computer simulations, is to evaluate the projected long-term cardiovascular impact of the new ArmoLIPID Cholesterol Plus formulation in adults with mild-to-moderate hypercholesterolemia and low-to-moderate cardiovascular risk. The main questions this study aims to answer are:

• Does the addition of ArmoLIPID Cholesterol Plus to lifestyle management reduce the projected incidence of major adverse cardiovascular events (MACE), including cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke?
• How does sustained LDL cholesterol reduction influence cumulative cardiovascular risk over 5, 10, 15, and 20 years?
• Could the use of ArmoLIPID Cholesterol Plus delay the projected need for statin therapy? Researchers will compare two simulated strategies: lifestyle management alone versus lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation. No human participants will be recruited, treated, or followed in this study. Using the Aeterna Deep computational platform, researchers will generate a synthetic population of 100,000 digital twins whose characteristics reflect those of adults with mild-to-moderate hypercholesterolemia. The simulations will incorporate clinical evidence from previous studies and model individual cardiovascular trajectories over a 20-year period. All cardiovascular outcomes will be computational projections rather than events observed in human participants.

Conditions

Hypercholesterolemia; Cardiovascular Risk

Keywords

Hypercholesterolemia; LDL Cholesterol; Cardiovascular Prevention; ArmoLIPID Cholesterol Plus; Nutraceuticals; Digital Twins; In Silico Clinical Trial; Major Adverse Cardiovascular Events (MACE)

Outcome Measures

Primary Outcomes (1)

• Projected Cumulative Incidence of First Major Adverse Cardiovascular Event (MACE)

  Estimation of the projected cumulative incidence of a first major adverse cardiovascular event (MACE), defined as the composite of cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, using the Aeterna Deep digital twin simulation platform. The outcome will be assessed across three simulated strategies: lifestyle management alone, lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory scenario involving two tablets daily with an assumed 32% LDL cholesterol reduction. Cumulative event probabilities, absolute risk differences, and model-derived hazard ratios will be estimated at 5, 10, 15, and 20 years. All events are computationally projected and are not observed clinical events in human participants.

  From simulation baseline to 5, 10, 15, and 20 years

Secondary Outcomes (7)

• Projected Cumulative LDL Cholesterol Exposure Over 20 Years

  From simulation baseline to 5, 10, 15, and 20 years

• Projected Incidence of Statin Therapy Indication

  From simulation baseline to 5, 10, 15, and 20 years

• Projected Time to First Statin Therapy Indication

  From simulation baseline up to 20 years

• Projected Cardiovascular Outcomes According to Supplementation Adherence

  From simulation baseline to 5, 10, 15, and 20 years

• Projected Number Needed to Treat (NNT) to Prevent One Major Adverse Cardiovascular Event

  From simulation baseline to 5, 10, 15, and 20 years

Study Arms (3)

Lifestyle Management (Reference Group)

Synthetic digital twins receiving simulated standard lifestyle management, including dietary recommendations, regular physical activity, and cardiovascular risk factor management, without ArmoLIPID Cholesterol Plus supplementation. This group serves as the reference comparator for estimating long-term cardiovascular outcomes over 5, 10, 15, and 20 years.

Lifestyle Management + ArmoLIPID Cholesterol Plus

Synthetic digital twins receiving simulated standard lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, without red yeast rice. The simulation estimates the long-term effects of LDL cholesterol reduction on cumulative cardiovascular exposure and the projected incidence of major adverse cardiovascular events (MACE) over 5, 10, 15, and 20 years.

Exploratory Scenario - Enhanced LDL-C Reduction (Two Tablets Daily)

Synthetic digital twins receiving simulated standard lifestyle management combined with two tablets daily of the new ArmoLIPID Cholesterol Plus formulation, without red yeast rice. This exploratory scenario assumes a sustained 32% reduction in LDL cholesterol (LDL-C) from baseline and evaluates its potential long-term impact on cumulative LDL-C exposure and the projected incidence of major adverse cardiovascular events (MACE) over 5, 10, 15, and 20 years. The assumed LDL-C reduction represents a hypothetical enhanced-response scenario and has not been clinically demonstrated for the two-tablet daily regimen. No human participants receive treatment in this simulation.

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 100,000 synthetic digital twins representing adults aged 30 to 65 years with mild-to-moderate hypercholesterolemia, baseline low-density lipoprotein cholesterol (LDL-C) levels between 115 and 189 mg/dL, and low-to-moderate estimated cardiovascular risk according to SCORE2. The synthetic population excludes individuals with established atherosclerotic cardiovascular disease, diabetes mellitus, or high-to-very-high cardiovascular risk at baseline. Digital twins are generated and analyzed using the Aeterna Deep computational platform to simulate individual cardiovascular trajectories over a 20-year period. Three virtual management strategies are evaluated: lifestyle management alone, lifestyle management combined with one daily tablet of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory two-tablet daily scenario assuming a hypothetical sustained 32% reduction in LDL-C. The study is conducted entirely in silico. No human participants are

You may qualify if:

• Synthetic digital twins representing adults aged 30 to 65 years.
• Baseline low-density lipoprotein cholesterol (LDL-C) levels between 115 and 189 mg/dL.
• Low-to-moderate estimated 10-year cardiovascular risk according to SCORE2.
• No history of established atherosclerotic cardiovascular disease (ASCVD).
• No diagnosis of diabetes mellitus at baseline.
• Availability of the simulated baseline characteristics required for cardiovascular risk estimation and longitudinal computational modeling.

You may not qualify if:

• Synthetic profiles representing individuals younger than 30 years or older than 65 years.
• Baseline LDL-C levels below 115 mg/dL or above 189 mg/dL.
• High or very high estimated cardiovascular risk according to SCORE2.
• History of established ASCVD, including previous myocardial infarction, ischemic stroke, or peripheral arterial disease.
• Diagnosis of diabetes mellitus at baseline.
• Synthetic profiles with missing or inconsistent baseline variables required for cardiovascular risk estimation or simulation.

Sponsors & Collaborators

• Aeterna Medical Solutions SL: lead

Study Sites (1)

Aeternal Medical Solutions SL

Madrid, Madrid, 28009, Spain

Location

Related Publications (6)

• SCORE2-OP working group and ESC Cardiovascular risk collaboration. SCORE2-OP risk prediction algorithms: estimating incident cardiovascular event risk in older persons in four geographical risk regions. Eur Heart J. 2021 Jul 1;42(25):2455-2467. doi: 10.1093/eurheartj/ehab312.

  PMID: 34120185 BACKGROUND

• Cholesterol Treatment Trialists' (CTT) Collaboration; Baigent C, Blackwell L, Emberson J, Holland LE, Reith C, Bhala N, Peto R, Barnes EH, Keech A, Simes J, Collins R. Efficacy and safety of more intensive lowering of LDL cholesterol: a meta-analysis of data from 170,000 participants in 26 randomised trials. Lancet. 2010 Nov 13;376(9753):1670-81. doi: 10.1016/S0140-6736(10)61350-5. Epub 2010 Nov 8.

  PMID: 21067804 BACKGROUND

• SCORE2 working group and ESC Cardiovascular risk collaboration. SCORE2 risk prediction algorithms: new models to estimate 10-year risk of cardiovascular disease in Europe. Eur Heart J. 2021 Jul 1;42(25):2439-2454. doi: 10.1093/eurheartj/ehab309.

  PMID: 34120177 BACKGROUND

• Visseren FLJ, Mach F, Smulders YM, Carballo D, Koskinas KC, Back M, Benetos A, Biffi A, Boavida JM, Capodanno D, Cosyns B, Crawford C, Davos CH, Desormais I, Di Angelantonio E, Franco OH, Halvorsen S, Hobbs FDR, Hollander M, Jankowska EA, Michal M, Sacco S, Sattar N, Tokgozoglu L, Tonstad S, Tsioufis KP, van Dis I, van Gelder IC, Wanner C, Williams B; ESC National Cardiac Societies; ESC Scientific Document Group. 2021 ESC Guidelines on cardiovascular disease prevention in clinical practice. Eur Heart J. 2021 Sep 7;42(34):3227-3337. doi: 10.1093/eurheartj/ehab484. No abstract available.

  PMID: 34458905 BACKGROUND

• Ference BA, Ginsberg HN, Graham I, Ray KK, Packard CJ, Bruckert E, Hegele RA, Krauss RM, Raal FJ, Schunkert H, Watts GF, Boren J, Fazio S, Horton JD, Masana L, Nicholls SJ, Nordestgaard BG, van de Sluis B, Taskinen MR, Tokgozoglu L, Landmesser U, Laufs U, Wiklund O, Stock JK, Chapman MJ, Catapano AL. Low-density lipoproteins cause atherosclerotic cardiovascular disease. 1. Evidence from genetic, epidemiologic, and clinical studies. A consensus statement from the European Atherosclerosis Society Consensus Panel. Eur Heart J. 2017 Aug 21;38(32):2459-2472. doi: 10.1093/eurheartj/ehx144.

  PMID: 28444290 BACKGROUND

• Fogacci F, Di Micoli V, Veronesi M, Cicero AFG. Comparative effect of a nutraceutical compound based on a flavonoid complex from bergamot on plasma lipids, glucose metabolism, and liver enzymes: a 3-arm, double-blind, placebo-controlled, randomized clinical trial. Arch Med Sci. 2022 Sep 9;19(5):1180-1185. doi: 10.5114/aoms/152791. eCollection 2023.

  PMID: 37732027 BACKGROUND

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start: September 1, 2026
• Primary Completion: October 3, 2026
• Study Completion: October 14, 2026
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)