An observational study in Hypercholesterolemia and Cardiovascular Risk, sponsored by Aeterna Medical Solutions SL. Completed at 1 site in Spain. Open to participants aged 30 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Aeterna Medical Solutions SL · Observational
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:
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.
1,267 studies on the registry are indexed under Hypercholesterolemia; 105 are open to participants now.
This study's enrollment of 100,000 is above the median of 805 across 188 observational studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →Aeterna Medical Solutions SL is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
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.
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.
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Cumulative LDL Cholesterol Exposure Over 20 Years
Estimation of cumulative exposure to low-density lipoprotein cholesterol (LDL-C) over 5, 10, 15, and 20 years, calculated as the area under the simulated LDL-C concentration-time curve and expressed in mg/dL-years. The analysis will compare lifestyle management alone with lifestyle management plus one tablet daily of the new ArmoLIPID Cholesterol Plus formulation and an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL-C. Differences in cumulative LDL-C exposure between simulated strategies will be assessed to characterize the potential long-term impact of sustained cholesterol lowering. All LDL-C trajectories are computationally simulated and do not represent longitudinal measurements obtained from human participants.
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Incidence of Statin Therapy Indication
Estimation of the projected proportion of synthetic digital twins meeting predefined clinical criteria for initiation of statin therapy over 5, 10, 15, and 20 years. The analysis will compare three simulated strategies: lifestyle management alone, lifestyle management combined with one tablet daily of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol (LDL-C). Statin therapy indication will be determined using the cardiovascular risk and LDL-C thresholds specified in the simulation model. Differences between strategies will be assessed to estimate the potential impact of sustained LDL-C lowering on the future need for lipid-lowering pharmacotherapy. All outcomes are computational projections and do not represent treatment decisions made for human participants.
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Time to First Statin Therapy Indication
Estimation of the simulated time from baseline to the first occurrence of predefined clinical criteria for statin therapy initiation, expressed in years. The analysis will compare lifestyle management alone, lifestyle management combined with one tablet daily of the new ArmoLIPID Cholesterol Plus formulation, and an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol (LDL-C). Time-to-event analyses will assess whether sustained LDL-C lowering may delay the projected indication for statin therapy. All outcomes are derived from computational simulations and do not represent actual prescribing decisions or clinical follow-up of human participants.
Time frame: From simulation baseline up to 20 years
Projected Cardiovascular Outcomes According to Supplementation Adherence
Assessment of the association between simulated long-term adherence to ArmoLIPID Cholesterol Plus supplementation and the projected cumulative incidence of major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The analysis will evaluate adherence scenarios incorporated into the Aeterna Deep computational model and compare their projected cardiovascular outcomes over 5, 10, 15, and 20 years. All adherence patterns and cardiovascular events are computationally simulated and do not represent observed behavior or clinical outcomes in human participants.
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Number Needed to Treat (NNT) to Prevent One Major Adverse Cardiovascular Event
Estimation of the model-derived number needed to treat (NNT) to prevent one first major adverse cardiovascular event (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. The NNT will be calculated as the inverse of the absolute difference in projected cumulative MACE incidence between lifestyle management alone and each simulated ArmoLIPID Cholesterol Plus supplementation strategy at 5, 10, 15, and 20 years. The analysis will include the one-tablet daily strategy and the exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol. NNT estimates represent hypothetical benefits derived from computational simulations and should not be interpreted as clinically demonstrated treatment effects.
Time frame: From simulation baseline to 5, 10, 15, and 20 years
Projected Major Adverse Cardiovascular Event-Free Survival Time
Estimation of the projected time free from a first major adverse cardiovascular event (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke, over a 20-year simulation horizon. Restricted mean MACE-free survival time will be estimated from the simulated event-free survival curves and expressed in years. The analysis will compare lifestyle management alone with lifestyle management plus one tablet daily of the new ArmoLIPID Cholesterol Plus formulation and an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol (LDL-C). Between-strategy differences will be used to quantify the projected gain in MACE-free survival time. All estimates are derived from computational simulations and do not represent observed clinical outcomes in human participants.
Time frame: From simulation baseline up to 20 years
Model-Derived Hazard Ratio for First Major Adverse Cardiovascular Event (MACE)
Estimation of model-derived hazard ratios (HRs) for the time to first major adverse cardiovascular event (MACE), defined as cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke. Hazard ratios will compare simulated lifestyle management alone with lifestyle management combined with one tablet daily of the new ArmoLIPID Cholesterol Plus formulation and, separately, an exploratory two-tablet daily scenario assuming a sustained 32% reduction in LDL cholesterol (LDL-C). Estimates will be accompanied by uncertainty intervals derived from the computational model. All hazard ratios represent simulated associations and should not be interpreted as treatment effects demonstrated in a clinical trial involving human participants.
Time frame: From simulation baseline up to 20 years
Plan to share: No — This study is conducted entirely in silico using 100,000 synthetic digital twins generated and analyzed through the Aeterna Deep computational platform. No individual participant data from enrolled human subjects are collected or generated. The underlying synthetic datasets and simulation outputs are not planned for public sharing, as they form part of the proprietary computational framework of Aeterna Medical Solutions SL. Aggregated study findings will be disseminated through scientific publications and reports.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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