NCT05988866Completed
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol. The main questions it aims to answer are: * Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone? * Does lipodia help improve other health outcomes, like how confident participants feel in managing their health? Researchers will compare two groups: * Intervention group: Participants use the lipodia intervention and continue their usual treatment. * Control group: Participants continue with their usual treatment only. Participants will: * Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months * Have blood tests at each lab visit to check their cholesterol and other blood fat levels * Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 278 (actual)
- First submitted
- 3 Aug 2023
- Start date
- 3 Feb 2025
- Primary completion date
- 22 May 2026
- Lead sponsor
- Gaia AG
- Diseases
- Familial hypercholesterolaemia
- NCT number
- NCT05988866
What you commit to
- Study type: Interventional
- Participants enrolled: 278
- From 3 Feb 2025 to the primary completion date, 22 May 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
- Patients receiving plasmapheresis
- Plans to change drug (including hormonal) treatment in the upcoming 6 months
Other illness
- Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes
- Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes
- end-stage renal failure
- other systemic conditions that might interfere with successful study participation
Lab values
- Lp(a) \> 50 mg/dL
Other
- current pregnancy or planned pregnancy during the study period
- planned major operations
- liver dysfunction
- Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past
Who the study is looking for
- Age ≥ 18
- Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis
- LDL-C levels above risk-adapted target
- TG levels \< 400 mg/dL
- Stability of potential drug treatment during the last 4 weeks
- Stability of potential hormonal treatment during the last 6 months
- Patient was made aware of lifestyle measures by GP or specialist
- Consent to participation
- Sufficient knowledge of the German language
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GAIA AG Coordinator of this site? Confirm its status | Hamburg | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.