HypercholesterolemiaPhase 2NCT00677248
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Ezetimibe
A Phase 2 study testing Eprotirome and ezetimibe in people with Hypercholesterolemia, run by Karo Bio AB at 1 site in Sweden.
Trial summary
Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in clinical trials demonstrated pronounced reduction of several independent risk factors for the development of atherosclerotic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- Eprotirome and ezetimibe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2008to Oct 2008
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 to 75 years
- Patient with primary hypercholesterolemia with an LDL-cholesterol > 3.0 mmol/L
- At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study
Who cannot join
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Placebo-Controlled, Double-Blind, Randomised, 10-Week, Parallel-Group Study to Assess the Efficacy of Different Doses of KB2115 as Add on to Ezetimibe Treatment in Patients With Primary Hypercholesterolemia
Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in clinical trials demonstrated pronounced reduction of several independent risk factors for the development of atherosclerotic cardiovascular diseases.
The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a clinically relevant dose or dose range for future studies.
- Conditions
- Hypercholesterolemia
- Being tested
- Ezetimibe and placebo, Eprotirome and ezetimibe
- Keywords
- Eprotirome, KB2115, dyslipidemia, hypercholesterolemia, hypertriglyceridemia
- Medical subject headings
- Hypercholesterolemia, Dyslipidemias, Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ezetimibe and placeboDrug
Placebo or three different doses of eprotirome added to ezetimibe treatment
Eprotirome and ezetimibeDrug
Placebo or three different doses of eprotirome added to ezetimibe treatment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Ezetimibe and placebo Receives: Drug: Ezetimibe and placebo |
| 2 | Experimental | Eprotirome dose 1 and ezetimibe Receives: Drug: Eprotirome and ezetimibe |
| 3 | Experimental | Eprotirome dose 2 and ezetimibe Receives: Drug: Eprotirome and ezetimibe |
| 4 | Experimental | Eprotirome dose 3 and ezetimibe Receives: Drug: Eprotirome and ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
Measured: 10 weeks
Secondary outcomes (1)
Triglycerides
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2008 (estimated)
- Study startApr 2008
- Primary completionSep 2008
- Study completionOct 2008
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karo Bio AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jens D Kristensen, MD, PhD, Study chair, Karo Bio AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00677248
- Sponsor's protocol ID
- 2007-007831-24
- Status last verified
- May 2008
- First submitted
- 12 May 2008
- Last updated
- 1 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Placebo-Controlled, Double-Blind, Randomised, 10-Week, Parallel-Group Study to Assess the Efficacy of Different Doses of KB2115 as Add on to Ezetimibe Treatment in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT00677248
- Acronym / sponsor ID
- 2007-007831-24
- Conditions
- Hypercholesterolemia
- Keywords
- Eprotirome, KB2115, dyslipidemia, hypercholesterolemia, hypertriglyceridemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Karo Bio ABIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 14 May 2008 (estimated)
- 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.
Eprotirome (KB2115) is a liver selective thyroid hormone that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. Eprotirome has in clinical trials demonstrated pronounced reduction of several independent risk factors for the development of atherosclerotic cardiovascular diseases.
The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to ezetimibe following 10 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 and to define a clinically relevant dose or dose range for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: Ezetimibe and placeboEzetimibe and placebo |
| 2 | Experimental | Drug: Eprotirome and ezetimibeEprotirome dose 1 and ezetimibe |
| 3 | Experimental | Drug: Eprotirome and ezetimibeEprotirome dose 2 and ezetimibe |
| 4 | Experimental | Drug: Eprotirome and ezetimibeEprotirome dose 3 and ezetimibe |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females aged 18 to 75 years
- Patient with primary hypercholesterolemia with an LDL-cholesterol > 3.0 mmol/L
- At randomization, diet as instructed by the investigator during the last 4 weeks prior to randomization and willingness to follow these instructions throughout the study
Key exclusion criteria (1 listed)
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study
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 |
|---|---|---|
| Ezetimibe and placeboPlacebo or three different doses of eprotirome added to ezetimibe treatment | Drug | 1 |
| Eprotirome and ezetimibePlacebo or three different doses of eprotirome added to ezetimibe treatment | Drug | 2, 3, 4 |
Primary outcome
LDL cholesterol
Time frame: 10 weeks
1 secondary outcome
Triglycerides
Time frame: 10 weeks
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 1 Dec 2008.
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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.
Jens D Kristensen, MD, PhD study chair
Karo Bio AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eprotirome and ezetimibe in people with Hypercholesterolemia, run by Karo Bio AB at 1 site in Sweden.
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 3 inclusion and 1 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 1 Dec 2008. 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 Sweden. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
LDL cholesterol (time frame: 10 weeks). 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 1 Dec 2008.