NCT07892092Completed
Long-Term Cardiovascular Impact of ArmoLIPID Cholesterol Plus: An In Silico Study Using Digital Twins
Long-Term Cardiovascular Impact of the New ArmoLIPID Cholesterol Plus Formulation: An In Silico Clinical Study Using 100,000 Digital Twins
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100000 (actual)
- First submitted
- 17 Oct 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 3 Oct 2026
- Lead sponsor
- Aeterna Medical Solutions SL
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT07892092
What you commit to
- Study type: Observational
- Participants enrolled: 100000
- From 1 Sept 2026 to the primary completion date, 3 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- History of established ASCVD, including previous myocardial infarction, ischemic stroke, or peripheral arterial disease.
Other illness
- Diagnosis of diabetes mellitus at baseline.
Lab values
- Baseline LDL-C levels below 115 mg/dL or above 189 mg/dL.
Age
- Synthetic profiles representing individuals younger than 30 years or older than 65 years.
Other
- High or very high estimated cardiovascular risk according to SCORE2.
- Synthetic profiles with missing or inconsistent baseline variables required for cardiovascular risk estimation or simulation.
Who the study is looking for
- 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 Systematic Coronary Risk Evaluation 2 (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.
Age in the registry: 30 years to 65 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aeternal Medical Solutions SL Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.