DyslipidemiaPhase 2NCT00593047
LDL-Cholesterol Lowering Effect of KB2115 as Add on to Statin
A Phase 2 study testing KB2115 in people with Dyslipidemia, run by Karo Bio AB at 1 site in Sweden.
Trial summary
Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key enzymes involved in synthesis, degradation, and lipid transport. However, the currently marketed thyroid agonists are non-selective, and cannot be used for the treatment of hypercholesterolemia due to extrahepatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- KB2115
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2007to Sep 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
- Signed informed consent
- Males or females aged 18 to 75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfil the following:
- Non-nursing and non-pregnant 12 months prior to enrolment
- Not of child bearing potential ie, either documented irreversible surgically sterile (bilateral oophorectomy or hysterectomy is acceptable, but not tubal ligation) or post-menopausal. Post-menopausal is defined as serum follicle-stimulating hormone (FSH) levels in the post-menopausal range combined with amenorrhea for more than 1 year in a woman above 50 years of age, or amenorrhea for more than 2 years below 50 years of age
- Patients with hypercholesterolemia treated with stable doses of the below listed lipid lowering medication for at least 3 months prior to randomization
- Atorvastatin not more than 20 mg/day or
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- Simvastatin not more than 40 mg/day
- LDL-cholesterol > 3.0 mmol/L (Week -1)
- Subject able and willing to comply with all study requirements
- 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
- Cholesterol lowering agents other than the defined statins
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator
- Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator
- Chronic (> 3 months) pain condition requiring daily medication with pain killers
- Glycosylated haemoglobin (HbA1c) > 7.0%
- Diabetes requiring medication other than metformin
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- Clinically abnormal physical findings and laboratory values as judged by the investigator and abnormal resting ECG, eg, QTc interval > 450 msec
- Body Mass Index of ≥ 40 kg/m2
- Resent history (< 3 month) of stroke or transient ischemic attacks
- History of seizure disorder, except febrile convulsions
- A current diagnosis of cancer, unless in remission
- Blood pressure (BP) of > 160/95 mm Hg
- History of cardiac arrhythmia, such as intermittent supraventricular tachyarrhythmia and atrial fibrillation
- Unstable angina pectoris, myocardial infarction or coronary bypass graft surgery or percutaneous coronary intervention < 6 month before randomization
- Congestive heart failure New York Heart Association Class > 2
- Unstable or severe angina pectoris or peripheral artery disease
- Known thyroid disease or thyroid biomarkers (TSH, T3, free T3, T4, free T4) outside reference range for normal at enrolment and at baseline
- Positive urine pregnancy test in women at enrolment
- Use of thyroid replacement therapy and hormone replacement therapy (including contraceptive pills) for last 3 months before randomization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Placebo-Controlled, Double-Blind, Randomised, 12-Week, Parallel-Group Study to Assess the Efficacy of Different Doses of KB2115 as Add on to Statin Treatment in Patients With Dyslipidemia
Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key enzymes involved in synthesis, degradation, and lipid transport. However, the currently marketed thyroid agonists are non-selective, and cannot be used for the treatment of hypercholesterolemia due to extrahepatic consequences of hyperthyroidism, especially on heart, bone, and muscle.
To take advantage of thyroid hormone effect on lipid metabolism for the treatment of hypercholesterolemia, it is necessary to develop a selective thyroid receptor agonist that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. KB2115 is a thyroid agonist developed to be liver selective.
The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to low and middle doses of statin following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 at doses between 25 and 100 µg and to define a clinically relevant dose or dose range for future studies.
- Conditions
- Dyslipidemia
- Being tested
- KB2115
- Keywords
- hypercholesterolemia
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KB2115Drug
tablet formulation given once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Statin + placebo Receives: Drug: KB2115 |
| 2 | Experimental | Statin + KB2115 dose 1 Receives: Drug: KB2115 |
| 3 | Experimental | Statin + KB2115 dose 2 Receives: Drug: KB2115 |
| 4 | Experimental | Statin + KB2115 dose 3 Receives: Drug: KB2115 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL cholesterol
Measured: 12 weeks
Secondary outcomes (1)
Triglyceride
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startNov 2007
- Primary completionJul 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karo Bio AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jens Kristensen, MD, PhD, Study director, Karo Bio AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593047
- Sponsor's protocol ID
- KBT004
- Other IDs
- 2007-004413-33
- Status last verified
- May 2008
- First submitted
- 17 Dec 2007
- Last updated
- 1 Dec 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ladenson PW, Kristensen JD, Ridgway EC, Olsson AG, Carlsson B, Klein I, Baxter JD, Angelin B. Use of the thyroid hormone analogue eprotirome in statin-treated dyslipidemia. N Engl J Med. 2010 Mar 11;362(10):906-16. doi: 10.1056/NEJMoa0905633.
PubMed 20220185
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, 12-Week, Parallel-Group Study to Assess the Efficacy of Different Doses of KB2115 as Add on to Statin Treatment in Patients With Dyslipidemia
- ClinicalTrials.gov ID
- NCT00593047
- Acronym / sponsor ID
- KBT004
- Conditions
- Dyslipidemia
- Keywords
- hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Karo Bio ABIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 14 Jan 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.
Thyroid hormones are known to reduce cholesterol levels through regulation of a number of key enzymes involved in synthesis, degradation, and lipid transport. However, the currently marketed thyroid agonists are non-selective, and cannot be used for the treatment of hypercholesterolemia due to extrahepatic consequences of hyperthyroidism, especially on heart, bone, and muscle.
To take advantage of thyroid hormone effect on lipid metabolism for the treatment of hypercholesterolemia, it is necessary to develop a selective thyroid receptor agonist that can induce hyperthyroidism in the liver, while an euthyroid state is preserved in the extrahepatic tissue. KB2115 is a thyroid agonist developed to be liver selective.
The purpose of the study is to assess the efficacy and safety of KB2115 as add on therapy to low and middle doses of statin following 12 weeks of exposure compared to placebo. The aim of the study is to assess efficacy (LDL-cholesterol lowering effects) and safety of KB2115 at doses between 25 and 100 µg and to define a clinically relevant dose or dose range for future studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: KB2115Statin + placebo |
| 2 | Experimental | Drug: KB2115Statin + KB2115 dose 1 |
| 3 | Experimental | Drug: KB2115Statin + KB2115 dose 2 |
| 4 | Experimental | Drug: KB2115Statin + KB2115 dose 3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent
- Males or females aged 18 to 75 years. Female patients must be non-fertile. To be considered as non-fertile, females must fulfil the following:
- Patients with hypercholesterolemia treated with stable doses of the below listed lipid lowering medication for at least 3 months prior to randomization
- LDL-cholesterol > 3.0 mmol/L (Week -1)
- Subject able and willing to comply with all study requirements
Key exclusion criteria (19 listed)
- Cholesterol lowering agents other than the defined statins
- History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study as judged by the investigator
- Clinically significant illness or clinically relevant trauma within 2 weeks before the administration of the investigational product as judged by the investigator
- Chronic (> 3 months) pain condition requiring daily medication with pain killers
- Glycosylated haemoglobin (HbA1c) > 7.0%
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 |
|---|---|---|
| KB2115tablet formulation given once daily for 12 weeks | Drug | 1, 2, 3, 4 |
Primary outcome
LDL cholesterol
Time frame: 12 weeks
1 secondary outcome
Triglyceride
Time frame: 12 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.
- Derived from this study: PubMed 20220185Ladenson PW, Kristensen JD, Ridgway EC, Olsson AG, Carlsson B, Klein I, Baxter JD, Angelin B. Use of the thyroid hormone analogue eprotirome in statin-treated dyslipidemia. N Engl J Med. 2010 Mar 11;362(10):906-16. doi: 10.1056/NEJMoa0905633.
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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 Kristensen, MD, PhD study director
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 KB2115 in people with Dyslipidemia, 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 10 inclusion and 19 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: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00593047, which also lists 1 linked publication.
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.