HypercholesterolemiaDIGICHOLNCT05988866
Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels
A study testing lipodia in people with Hypercholesterolemia and Dyslipidemias, run by Gaia AG at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypercholesterolemia, Dyslipidemias
- What is being tested?
- lipodia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteGermany
- Study dates
- 3 Feb 2025to 22 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- Patient was made aware of lifestyle measures by GP or specialist
- Consent to participation
- Sufficient knowledge of the German language
Who cannot join
- 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
- Patients receiving plasmapheresis
- Lp(a) > 50 mg/dL
- current pregnancy or planned pregnancy during the study period
- planned major operations
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- liver dysfunction
- end-stage renal failure
- other systemic conditions that might interfere with successful study participation
- Plans to change drug (including hormonal) treatment in the upcoming 6 months
- Use of another digital intervention for hypercholesterolemia/dyslipidemia in the past
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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:
Read more
- 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)
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Being tested
- lipodia
- Keywords
- LDL-C, digital intervention
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipodiaBehavioural
Participants will receive access to the digital health intervention lipodia in addition to TAU.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU).
lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking.
The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days. Receives: Behavioral: lipodia |
| Control group | No intervention | Participants allocated to the control group will receive access to treatment as usual (TAU). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting LDL-C levels
Measured: 6 months
Secondary outcomes (7)
Patients' activation
Assessed with the total score of the PAM-13. Higher scores indicate higher patient activation (better outcome).
Measured: 6 months
Fasting non-HDL-C levels
Measured: 6 months
Health-related quality of life
Assessed with the total score of the AQoL-8D. Higher scores indicate higher quality of life (better outcome).
Measured: 6 months
BMI
Measured: 6 months
Fasting triglyceride levels
Measured: 6 months
Fasting HDL-C levels
Measured: 6 months
Fasting LDL-C levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start3 Feb 2025
- Primary completion22 May 2026
- Study completion22 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaia AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Kiel
- Responsible party
- Sponsor
- Investigators
- Kamila Jauch-Chara, Prof., Principal investigator, Christian-Albrechts-Universität zu Kiel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988866
- Sponsor's protocol ID
- lipodia RCT 2025
- Acronym
- DIGICHOL
- Status last verified
- Jul 2026
- First submitted
- 3 Aug 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05988866
- Acronym / sponsor ID
- DIGICHOL / lipodia RCT 2025
- Conditions
- Hypercholesterolemia, Dyslipidemias
- Keywords
- LDL-C, digital intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Gaia AGIndustry (pharma, biotech, devices)
- Collaborators
- University of Kiel
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 22 May 2026 (actual)
- Study completion
- 22 May 2026 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: lipodiaParticipants allocated to the intervention group will receive access to lipodia in addition to treatment as usual (TAU). lipodia is a digital health application designed for individuals with hypercholesterinemia, accessible through a web browser. The application focuses on treatment methods derived health behavior change and cognitive behavioral therapy (CBT). Topics addressed by lipodia are activity planning and impulse control, dietary habits, physical activity, stress management, mood management, sleep management, weight management, as well as quitting smoking and drinking. The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivating text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 365 days. |
| Control group | No intervention | –Participants allocated to the control group will receive access to treatment as usual (TAU). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- Patients receiving plasmapheresis
- Lp(a) > 50 mg/dL
- current pregnancy or planned pregnancy during the study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lipodiaParticipants will receive access to the digital health intervention lipodia in addition to TAU. | Behavioural | Intervention group |
Primary outcome
Fasting LDL-C levels
Time frame: 6 months
7 secondary outcomes
Patients' activation
Time frame: 6 months
Fasting non-HDL-C levels
Time frame: 6 months
Health-related quality of life
Time frame: 6 months
BMI
Time frame: 6 months
Fasting triglyceride levels
Time frame: 6 months
Fasting HDL-C levels
Time frame: 6 months
Fasting LDL-C levels
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Hypercholesterolemia
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A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kamila Jauch-Chara, Prof. principal investigator
Christian-Albrechts-Universität zu Kiel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lipodia in people with Hypercholesterolemia and Dyslipidemias, run by Gaia AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting LDL-C levels (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.