Type II HyperlipidemiaPhase 2NCT01388816
A Safety and Efficacy Study of DRL-17822, a Cholesteryl Ester Transfer Protein (CETP) Inhibitor, in Patients With Abnormal Cholesterol Levels
A Phase 2 study of Type II Hyperlipidemia, run by Dr. Reddy's Laboratories Limited at 12 sites in 3 countries.
Trial summary
The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type II Hyperlipidemia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 176 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jul 2011to Jun 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Type II hyperlipidemia having lipid values of HDL-C: males ≤ 44 mg/dL (≤1.13 mmol/L), females ≤ 54 mg/dL (≤1.39 mmol/L); LDL-C: ≥ 130 mg/dL (≥3.33 mmol/L);
- Male or female, 18 to 70 years of age, inclusive. Female patients must be postmenopausal or surgically sterile. Men, unless surgically sterile must practice birth control from screening until the end of the study;
- Ability and willingness to give written informed consent;
- No clinically significant abnormal findings on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory profiles of both blood and urine.
Who cannot join
- Patients with significant cardiac disease such as myocardial infarction, heart failure, coronary or peripheral artery angioplasty, bypass graft surgery, severe or unstable angina pectoris, cardiac arrhythmias, hypertension or any other disease which requires treatment;
- Uncontrolled diabetes (HbA1c > 8.0%);
- History of symptomatic cerebrovascular disease such as symptomatic carotid artery disease, cerebrovascular hemorrhage, transient ischemic attack or carotid endarterectomy or any disease which requires treatment;
- History of clinically significant hematologic, renal, hepatic, neurologic, endocrine, oncologic, pulmonary, immunologic or psychiatric disorders;
- Any current or recent (within 4 weeks of run-in) concomitant therapy (apart from paracetamol/acetaminophen and non-steroidal anti-inflammatory drugs [NSAIDs]). Patients on previous concomitant treatment may enter the study if the treatment has been discontinued, when appropriate and if ethically justified, at least four weeks prior to run-in;
- Body mass index (BMI)> 35 kg/m(2);
Show all 15Show fewer
- Positive for hepatitis B, C or HIV or known history or concurrent tuberculosis;
- Positive drug screen result (i.e., cocaine, opiates, amphetamine, cannabis, barbiturates, benzodiazepines and/or metadone);
- Pregnant, breast feeding or women of child-bearing potential;
- Regular use of non-drug therapies such as garlic supplements and St. John's Wort;
- Presence or history of alcoholism or drug abuse;
- Use of more than 21 units of alcohol per week for males or more than 14 units per week for females;
- Smoking within 3 months prior to screening;
- Relevant drug hypersensitivity or allergy or any serious adverse event reaction to lipid regulating agents;
- Administration of study drug in another drug study within 90 days prior to enrollment or participation in another drug trial from screening to last follow-up of this study; Any surgical or medical condition which makes the patient unsuitable to participate in the opinion of the Investigator.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Italy5 sites
Study site
Genova
Study site
Milan
Study site
Modena
Study site
Palermo
Study site
Perugia
Poland4 sites
Study site
Gdynia
Study site
Gniewkowo
Study site
Katowice
Study site
Wroclaw
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of DRL-17822 in Patients With Type II Hyperlipidemia
The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease.
Read the detailed description
Cardiovascular disease is a leading cause of death worldwide. Among cardiovascular disorders, coronary heart disease (CHD) caused by atherosclerosis is the most common cause of morbidity and mortality. Prevention, stabilization and regression of atherosclerotic plaques may have a major impact on reducing the risk of acute coronary events.
LDL-C lowering agents, primarily the statins, are the current mainstay in the pharmacologic management of dyslipidemia. However even with stain use, residual CHD risk from dyslipidemia remains. Epidemiologic and observational studies have shown that HDL-C is also a strong independent predictor of CHD, suggesting that raising HDL-C levels might afford clinical benefit in the reduction of cardiovascular risk.
Presently only niacin is approved by the FDA for HDL-C elevation and can raise HDL-C levels by 20-30%. However its use can be limited by a high incidence of flushing and, less commonly, by elevation of blood glucose and potential hepatic toxicity.
Cholesteryl ester transfer protein (CETP) inhibitors are being explored for their ability to elevate HDL-C. A small molecule CETP inhibitor, torcetrapib, has been demonstrated to elevate HDL-C by 60-100%. However, a large clinical trial (ILLUMINATE) where it increased HDL-C by a mean of 72% compared to baseline was halted as it failed to show benefit. Post-hoc analysis of this study implicated an off-target increase in blood pressure as potentially counteracting any anti-atherosclerotic benefits. Post-hoc subgroup analysis showed that patients in the highest HDL-C quartile had a 57% reduction in the risk of cardiovascular events.
Increased blood pressure appears to be specifically related to torcetrapib as two other small molecule CETP inhibitors, anacetrapib and dalcetrapib, have not shown this in clinical trials and have been well tolerated. DRL-17822 has also not shown elevation of blood pressure in either animals or in normal volunteers.
This study will investigate the efficacy and tolerability of DRL-17822 as dyslipidemia monotherapy in patients with Type II hyperlipidemia.
- Conditions
- Type II Hyperlipidemia
- Being tested
- DRL-17822 or placebo
- Keywords
- Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Type II Hyperlipidemia, Cholesteryl Ester Transferase Protein Inhibitor, CETP Inhibitor
- Medical subject headings
- Hyperlipoproteinemia Type II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DRL-17822 or placeboDrug
DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast
| Study group | Role | What they receive |
|---|---|---|
| Placebo capsule | Placebo comparator | Not described Receives: Drug: DRL-17822 or placebo |
| DRL-17822 50 mg | Experimental | Not described Receives: Drug: DRL-17822 or placebo |
| DRL-17822 150 mg | Experimental | Not described Receives: Drug: DRL-17822 or placebo |
| DRL-17822 300 mg | Experimental | Not described Receives: Drug: DRL-17822 or placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in HDL-C From Baseline
Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia
Measured: 28 days
Secondary outcomes (5)
Safety and Tolerability of DRL-17822
Incidence of treatment-related adverse events
Measured: 28 days
Changes in Vital Signs Including Blood Pressure
Vital sign abnormalities reported as treatment-emergent AEs
Measured: 28 days
To Evaluate Trough Levels of DRL-17822 in Plasma
Trough levels of DRL-17822 in plasma after 28 days of treatment
Measured: 28 days
Changes in CETP Inhibition in Plasma
Percent change from baseline in CETP Inhibition
Measured: 28 days
Changes in Other Lipids and Apolipoproteins
Change from baseline (LOCF, ITT population)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionMay 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type II HyperlipidemiaStudies 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
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Reddy's Laboratories Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PharmaNet
- Responsible party
- Sponsor
- Investigators
- Kent Allenby, MD, Study director, Dr. Reddy's Laboratories
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01388816
- Sponsor's protocol ID
- DRL-17822/CD/004
- Status last verified
- Mar 2014
- First submitted
- 5 Jul 2011
- Last updated
- 22 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of DRL-17822 in Patients With Type II Hyperlipidemia
- ClinicalTrials.gov ID
- NCT01388816
- Acronym / sponsor ID
- DRL-17822/CD/004
- Conditions
- Type II Hyperlipidemia
- Keywords
- Randomized, Double-Blind, Placebo Controlled, Parallel Arm, Type II Hyperlipidemia, Cholesteryl Ester Transferase Protein Inhibitor, CETP Inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Dr. Reddy's Laboratories LimitedIndustry (pharma, biotech, devices)
- Collaborators
- PharmaNet
- Study start
- Jul 2011
- Primary completion
- May 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 7 Jul 2011 (estimated)
- Results
- Posted 22 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a new drug, DRL-17822, is safe and effective in elevating high density lipoprotein cholesterol (HDL-C) and reducing low density lipoprotein cholesterol (LDL-C) in people with abnormal cholesterol levels that may put them at risk for heart disease.
Detailed description
Cardiovascular disease is a leading cause of death worldwide. Among cardiovascular disorders, coronary heart disease (CHD) caused by atherosclerosis is the most common cause of morbidity and mortality. Prevention, stabilization and regression of atherosclerotic plaques may have a major impact on reducing the risk of acute coronary events.
LDL-C lowering agents, primarily the statins, are the current mainstay in the pharmacologic management of dyslipidemia. However even with stain use, residual CHD risk from dyslipidemia remains. Epidemiologic and observational studies have shown that HDL-C is also a strong independent predictor of CHD, suggesting that raising HDL-C levels might afford clinical benefit in the reduction of cardiovascular risk.
Presently only niacin is approved by the FDA for HDL-C elevation and can raise HDL-C levels by 20-30%. However its use can be limited by a high incidence of flushing and, less commonly, by elevation of blood glucose and potential hepatic toxicity.
Cholesteryl ester transfer protein (CETP) inhibitors are being explored for their ability to elevate HDL-C. A small molecule CETP inhibitor, torcetrapib, has been demonstrated to elevate HDL-C by 60-100%. However, a large clinical trial (ILLUMINATE) where it increased HDL-C by a mean of 72% compared to baseline was halted as it failed to show benefit. Post-hoc analysis of this study implicated an off-target increase in blood pressure as potentially counteracting any anti-atherosclerotic benefits. Post-hoc subgroup analysis showed that patients in the highest HDL-C quartile had a 57% reduction in the risk of cardiovascular events.
Increased blood pressure appears to be specifically related to torcetrapib as two other small molecule CETP inhibitors, anacetrapib and dalcetrapib, have not shown this in clinical trials and have been well tolerated. DRL-17822 has also not shown elevation of blood pressure in either animals or in normal volunteers.
This study will investigate the efficacy and tolerability of DRL-17822 as dyslipidemia monotherapy in patients with Type II hyperlipidemia.
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 |
|---|---|---|
| Placebo capsule | Placebo comparator | Drug: DRL-17822 or placebo |
| DRL-17822 50 mg | Experimental | Drug: DRL-17822 or placebo |
| DRL-17822 150 mg | Experimental | Drug: DRL-17822 or placebo |
| DRL-17822 300 mg | Experimental | Drug: DRL-17822 or placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Type II hyperlipidemia having lipid values of HDL-C: males ≤ 44 mg/dL (≤1.13 mmol/L), females ≤ 54 mg/dL (≤1.39 mmol/L); LDL-C: ≥ 130 mg/dL (≥3.33 mmol/L);
- Male or female, 18 to 70 years of age, inclusive. Female patients must be postmenopausal or surgically sterile. Men, unless surgically sterile must practice birth control from screening until the end of the study;
- Ability and willingness to give written informed consent;
- No clinically significant abnormal findings on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory profiles of both blood and urine.
Key exclusion criteria (15 listed)
- Patients with significant cardiac disease such as myocardial infarction, heart failure, coronary or peripheral artery angioplasty, bypass graft surgery, severe or unstable angina pectoris, cardiac arrhythmias, hypertension or any other disease which requires treatment;
- Uncontrolled diabetes (HbA1c > 8.0%);
- History of symptomatic cerebrovascular disease such as symptomatic carotid artery disease, cerebrovascular hemorrhage, transient ischemic attack or carotid endarterectomy or any disease which requires treatment;
- History of clinically significant hematologic, renal, hepatic, neurologic, endocrine, oncologic, pulmonary, immunologic or psychiatric disorders;
- Any current or recent (within 4 weeks of run-in) concomitant therapy (apart from paracetamol/acetaminophen and non-steroidal anti-inflammatory drugs [NSAIDs]). Patients on previous concomitant treatment may enter the study if the treatment has been discontinued, when appropriate and if ethically justified, at least four weeks prior to run-in;
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 |
|---|---|---|
| DRL-17822 or placeboDRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast | Drug | DRL-17822 150 mg, DRL-17822 300 mg, DRL-17822 50 mg, Placebo capsule |
Primary outcome
Percent Change in HDL-C From Baseline
Time frame: 28 days
Percent change from baseline in HDL-C after 28 days of treatment in patients with Type II hyperlipidemia
5 secondary outcomes
Safety and Tolerability of DRL-17822
Time frame: 28 days
Changes in Vital Signs Including Blood Pressure
Time frame: 28 days
To Evaluate Trough Levels of DRL-17822 in Plasma
Time frame: 28 days
Changes in CETP Inhibition in Plasma
Time frame: 28 days
Changes in Other Lipids and Apolipoproteins
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Type II Hyperlipidemia
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Truway Diagnostic Tools in Primary Care
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An Observational Study to Evaluate Treatment Patterns in High, Very High and Extreme Cardiovascular Risk Patients With Hypercholesterolemia, Including Familial Hypercholesterolemia
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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.
Kent Allenby, MD study director
Dr. Reddy's Laboratories
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study of Type II Hyperlipidemia, run by Dr. Reddy's Laboratories Limited at 12 sites in 3 countries.
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 4 inclusion and 15 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 22 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Italy, Poland, Ukraine. 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?
Yes. Results are posted in the registry (first posted 22 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in HDL-C From Baseline (time frame: 28 days). 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 22 Apr 2014.