DyslipidemiaPhase 2NCT01105975
A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
A Phase 2 study testing LY2484595, Atorvastatin and Simvastatin in people with Dyslipidemia, run by Eli Lilly and Company at 59 sites in 6 countries.
Trial summary
The primary purpose of your participation in this study is to help answer the following research question(s) Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- LY2484595, Atorvastatin and Simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 398 participants
- Where
- 59 sitesin 6 countries
- Study dates
- Apr 2010to Jun 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies
Who cannot join
- History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well
- Hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (Electrocardiogram [ECG]) to be compatible with participation in the study
- History of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema)
- Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester Transfer Protein (CETP) inhibitors)
- Not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs
- Not willing to follow the diet (low-fat) that the study physician will recommend
- Have disease of liver, kidneys, muscles or other organs of body, a serious infection or cancer, or abnormal laboratory tests that study physician does not consider compatible with participation in the study
- Breastfeeding woman or a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies
Trial locations and contacts
59 sites in 6 countries.
59 sites in 6 countries
United States38 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Auburn, Maine, 04210
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Baltimore, Maryland, 21209
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Brandon, Florida, 33511
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Bristol, Tennessee, 37620
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Cary, North Carolina, 27518
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Charlotte, North Carolina, 28209
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Dallas, Texas, 75231
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Edison, New Jersey, 08817
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Endwell, New York, 13760
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Fayetteville, Arkansas, 72703
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Golden, Colorado, 80401
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Greensboro, North Carolina, 27408
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Greer, South Carolina, 29651
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Hickory, North Carolina, 28601
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Houston, Texas, 77030
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Indianapolis, Indiana, 46254
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Jacksonville, Florida, 32216
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Kingsport, Tennessee, 37660
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Lexington, Kentucky, 40504
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Longwood, Florida, 32779
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Mt. Pleasant, South Carolina, 29464
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Oregon, Wisconsin, 53575
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Philadelphia, Pennsylvania, 19152
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Picayune, Mississippi, 39466
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Ponte Vedra, Florida, 32081
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Raleigh, North Carolina, 27609
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Red Lion, Pennsylvania, 17356
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Salisbury, North Carolina, 28144
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San Diego, California, 92128
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Simpsonville, South Carolina, 29681
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Spring Valley, California, 91978
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Tacoma, Washington, 98405
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Vista, California, 92083
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Waterloo, Iowa, 50702
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Wichita, Kansas, 67708
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Wilmington, North Carolina, 28401
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Winston-Salem, North Carolina, 27103
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Yardley, Pennsylvania, 19067
Netherlands8 sites
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Amsterdam, 1105 AZ
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Breda, 4811 VL
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Eindhoven, 5611 NJ
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Geleen, 6160 BB
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Groningen, 9711 SG
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Leiderdorp, 2352 RA
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Rotterdam, 3021 HC
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Zoetermeer, 2724 EK
United Kingdom5 sites
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Birmingham, B15 2SQ
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Chorley, Lancashire, PR 7 7NA
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Glasgow, Scotland, G81 2DR
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Liverpool, Merseyside, L22 0LG
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Reading, Berkshire, RG2 7AG
Germany3 sites
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Berlin, 12627
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Bochum, 44787
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Leipzig, 04103
Poland3 sites
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Gdynia, 81-572
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Warsaw, 02-777
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Wroclaw, 50-088
Denmark2 sites
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Ballerup Municipality, 2750
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Vejle, 7100
About this study
Official title: A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination With Atorvastatin, Simvastatin, and Rosuvastatin in Patients With Hypercholesterolemia or Low HDL-C
The primary purpose of your participation in this study is to help answer the following research question(s)
- Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone.
- Whether LY2484595 alone improves blood fats profile compared to sugar pills.
- Whether LY2484595 interferes with break down or functioning of statins.
- Whether LY2484595 has any side effects that would not support testing it in future studies.
Read the detailed description
Patients will be stratified according to baseline levels of serum triglycerides (<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (<45 or greater than or equal to 45 mg/dL for men; <50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.
- Conditions
- Dyslipidemia
- Being tested
- LY2484595, Atorvastatin, Simvastatin, Rosuvastatin, Placebo for LY2484595
- Keywords
- Dyslipidemias, Mixed dyslipidemia, Hypercholesterolemia, Atherosclerosis, Atorvastatin, Simvastatin, Rosuvastatin, Metabolic Diseases, Antilipemic Agents, Enzyme Inhibitors, Anticholesteremic Agents, Cholesteryl Ester Transfer Protein Inhibitors, Cholesteryl Ester, Lipid Metabolism Disorders
- Medical subject headings
- Dyslipidemias, Hypercholesterolemia, Atherosclerosis, Metabolic Diseases, Lipid Metabolism Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY2484595Drug
Administered daily by mouth for 12 weeks
AtorvastatinDrug
Administered daily by mouth for 12 weeks
SimvastatinDrug
Administered daily by mouth for 12 weeks
RosuvastatinDrug
Administered daily by mouth for 12 weeks
Placebo for LY2484595Drug
Administered daily by mouth for 12 weeks
Placebo for StatinsDrug
Administered daily by mouth for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| 30 milligram (mg) LY2484595 monotherapy | Experimental | Not described Receives: Drug: LY2484595; Drug: Placebo for Statins |
| 100 mg LY2484595 monotherapy | Experimental | Not described Receives: Drug: LY2484595; Drug: Placebo for Statins |
| 500 mg LY2484595 monotherapy | Experimental | Not described Receives: Drug: LY2484595; Drug: Placebo for Statins |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo for LY2484595; Drug: Placebo for Statins |
| 20 mg Atorvastatin monotherapy | Active comparator | Not described Receives: Drug: Atorvastatin; Drug: Placebo for LY2484595 |
| 100 mg LY2484595 + 20 mg Atorvastatin | Experimental | Not described Receives: Drug: LY2484595; Drug: Atorvastatin |
| 40 mg Simvastatin monotherapy | Active comparator | Not described Receives: Drug: Simvastatin; Drug: Placebo for LY2484595 |
| 100 mg LY2484595 + 40 mg Simvastatin | Experimental | Not described Receives: Drug: LY2484595; Drug: Simvastatin |
| 10 mg Rosuvastatin monotherapy | Active comparator | Not described Receives: Drug: Rosuvastatin; Drug: Placebo for LY2484595 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | Experimental | Not described Receives: Drug: LY2484595; Drug: Rosuvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Secondary outcomes (15)
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State
Measured: Baseline up to 12 weeks
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
All rash cases were adjudicated by a central dermatologist blinded to treatment assignment according to a study-specific Clinical Events Committee (CEC) charter. Rash events were assessed according to clinical relevance (high risk, low risk, not a relevant dermatosis, or insufficient documentation for determination). A participant could be reported in multiple categories.
Measured: Baseline through Week 12
Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Serum Potassium
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Serum Sodium
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline, Week 12
Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score
EQ-5D is a health-related, quality-of-life instrument. It allows participants to rate their health state in 5 domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score 1 -3 is generated for each domain, with 1=no problem and 3= extreme problems. The outcome ratings on the 5 domains are mapped to a single index through an algorithm. The index ranges 0-1, with the higher score indicating a better health state perceived by the participants. LS Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Measured: Baseline up to Week 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionJun 2011
- Study completionJun 2011
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- 398 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105975
- Sponsor's protocol ID
- 12468
- Other IDs
- I1V-MC-EIAF
- Status last verified
- Feb 2018
- First submitted
- 15 Apr 2010
- Last updated
- 22 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nicholls SJ, Ruotolo G, Brewer HB, Wang MD, Liu L, Willey MB, Deeg MA, Krueger KA, Nissen SE. Evacetrapib alone or in combination with statins lowers lipoprotein(a) and total and small LDL particle concentrations in mildly hypercholesterolemic patients. J Clin Lipidol. 2016 May-Jun;10(3):519-527.e4. doi: 10.1016/j.jacl.2015.11.014. Epub 2015 Dec 18.
PubMed 27206939Nicholls SJ, Ruotolo G, Brewer HB, Kane JP, Wang MD, Krueger KA, Adelman SJ, Nissen SE, Rader DJ. Cholesterol Efflux Capacity and Pre-Beta-1 HDL Concentrations Are Increased in Dyslipidemic Patients Treated With Evacetrapib. J Am Coll Cardiol. 2015 Nov 17;66(20):2201-2210. doi: 10.1016/j.jacc.2015.09.013.
PubMed 26564598Nicholls SJ, Brewer HB, Kastelein JJ, Krueger KA, Wang MD, Shao M, Hu B, McErlean E, Nissen SE. Effects of the CETP inhibitor evacetrapib administered as monotherapy or in combination with statins on HDL and LDL cholesterol: a randomized controlled trial. JAMA. 2011 Nov 16;306(19):2099-109. doi: 10.1001/jama.2011.1649.
PubMed 22089718
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Efficacy and Safety Study of LY2484595 Alone and in Combination With Atorvastatin, Simvastatin, and Rosuvastatin in Patients With Hypercholesterolemia or Low HDL-C
- ClinicalTrials.gov ID
- NCT01105975
- Acronym / sponsor ID
- 12468
- Conditions
- Dyslipidemia
- Keywords
- Dyslipidemias, Mixed dyslipidemia, Hypercholesterolemia, Atherosclerosis, Atorvastatin, Simvastatin, Rosuvastatin, Metabolic Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 398 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 19 Apr 2010 (estimated)
- Results
- Posted 22 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of your participation in this study is to help answer the following research question(s)
- Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone.
- Whether LY2484595 alone improves blood fats profile compared to sugar pills.
- Whether LY2484595 interferes with break down or functioning of statins.
- Whether LY2484595 has any side effects that would not support testing it in future studies.
Detailed description
Patients will be stratified according to baseline levels of serum triglycerides (<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (<45 or greater than or equal to 45 mg/dL for men; <50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 30 milligram (mg) LY2484595 monotherapy | Experimental | Drug: LY2484595, Drug: Placebo for Statins |
| 100 mg LY2484595 monotherapy | Experimental | Drug: LY2484595, Drug: Placebo for Statins |
| 500 mg LY2484595 monotherapy | Experimental | Drug: LY2484595, Drug: Placebo for Statins |
| Placebo | Placebo comparator | Drug: Placebo for LY2484595, Drug: Placebo for Statins |
| 20 mg Atorvastatin monotherapy | Active comparator | Drug: Atorvastatin, Drug: Placebo for LY2484595 |
| 100 mg LY2484595 + 20 mg Atorvastatin | Experimental | Drug: LY2484595, Drug: Atorvastatin |
| 40 mg Simvastatin monotherapy | Active comparator | Drug: Simvastatin, Drug: Placebo for LY2484595 |
| 100 mg LY2484595 + 40 mg Simvastatin | Experimental | Drug: LY2484595, Drug: Simvastatin |
| 10 mg Rosuvastatin monotherapy | Active comparator | Drug: Rosuvastatin, Drug: Placebo for LY2484595 |
| 100 mg LY2484595 + 10 mg Rosuvastatin | Experimental | Drug: LY2484595, Drug: Rosuvastatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies
Key exclusion criteria (8 listed)
- History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well
- Hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (Electrocardiogram [ECG]) to be compatible with participation in the study
- History of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema)
- Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester Transfer Protein (CETP) inhibitors)
- Not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs
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 |
|---|---|---|
| LY2484595Administered daily by mouth for 12 weeks | Drug | 100 mg LY2484595 + 10 mg Rosuvastatin, 100 mg LY2484595 + 20 mg Atorvastatin, 100 mg LY2484595 + 40 mg Simvastatin, 100 mg LY2484595 monotherapy, 30 milligram (mg) LY2484595 monotherapy, 500 mg LY2484595 monotherapy |
| AtorvastatinAdministered daily by mouth for 12 weeks | Drug | 100 mg LY2484595 + 20 mg Atorvastatin, 20 mg Atorvastatin monotherapy |
| SimvastatinAdministered daily by mouth for 12 weeks | Drug | 100 mg LY2484595 + 40 mg Simvastatin, 40 mg Simvastatin monotherapy |
| RosuvastatinAdministered daily by mouth for 12 weeks | Drug | 10 mg Rosuvastatin monotherapy, 100 mg LY2484595 + 10 mg Rosuvastatin |
| Placebo for LY2484595Administered daily by mouth for 12 weeks | Drug | 10 mg Rosuvastatin monotherapy, 20 mg Atorvastatin monotherapy, 40 mg Simvastatin monotherapy, Placebo |
| Placebo for StatinsAdministered daily by mouth for 12 weeks | Drug | 100 mg LY2484595 monotherapy, 30 milligram (mg) LY2484595 monotherapy, 500 mg LY2484595 monotherapy, Placebo |
Primary outcome
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Time frame: Baseline, Week 12
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy
Time frame: Baseline, Week 12
Least Squares (LS) Mean values were controlled for region, baseline measurement, treatment, visit, and treatment by visit interaction.
15 secondary outcomes
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 and Placebo
Time frame: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 and Placebo
Time frame: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Time frame: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Low Density Lipoprotein Cholesterol (LDL-C) With LY2484595 in Combination With Simvastatin or Rosuvastatin and Simvastatin/Rosuvastatin Monotherapy
Time frame: Baseline, Week 12
Pharmacokinetics - LY2484595 Area Under the Concentration-Time Curve (AUC) at Steady-State
Time frame: Baseline up to 12 weeks
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Activity
Time frame: Baseline, Week 12
Percent Change From Baseline to 12 Weeks Endpoint in Plasma Cholesteryl Ester Transfer Protein (CETP) Mass
Time frame: Baseline, Week 12
The Number of Episodes of Rashes at Any Time From Baseline Through Week 12
Time frame: Baseline through Week 12
Change From Baseline to 12 Weeks Endpoint in Blood Pressure (BP)
Time frame: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Serum Aldosterone
Time frame: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Plasma Renin Activity
Time frame: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Serum Potassium
Time frame: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Serum Sodium
Time frame: Baseline, Week 12
Change From Baseline to 12 Weeks Endpoint in Serum Bicarbonate
Time frame: Baseline, Week 12
Change From Baseline to 18 Weeks Endpoint in EuroQoL Questionnaire - 5 Dimensions (EQ-5D) Score
Time frame: Baseline up to Week 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 27206939Nicholls SJ, Ruotolo G, Brewer HB, Wang MD, Liu L, Willey MB, Deeg MA, Krueger KA, Nissen SE. Evacetrapib alone or in combination with statins lowers lipoprotein(a) and total and small LDL particle concentrations in mildly hypercholesterolemic patients. J Clin Lipidol. 2016 May-Jun;10(3):519-527.e4. doi: 10.1016/j.jacl.2015.11.014. Epub 2015 Dec 18.
- Derived from this study: PubMed 26564598Nicholls SJ, Ruotolo G, Brewer HB, Kane JP, Wang MD, Krueger KA, Adelman SJ, Nissen SE, Rader DJ. Cholesterol Efflux Capacity and Pre-Beta-1 HDL Concentrations Are Increased in Dyslipidemic Patients Treated With Evacetrapib. J Am Coll Cardiol. 2015 Nov 17;66(20):2201-2210. doi: 10.1016/j.jacc.2015.09.013.
- Derived from this study: PubMed 22089718Nicholls SJ, Brewer HB, Kastelein JJ, Krueger KA, Wang MD, Shao M, Hu B, McErlean E, Nissen SE. Effects of the CETP inhibitor evacetrapib administered as monotherapy or in combination with statins on HDL and LDL cholesterol: a randomized controlled trial. JAMA. 2011 Nov 16;306(19):2099-109. doi: 10.1001/jama.2011.1649.
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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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
59 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY2484595, Atorvastatin and Simvastatin in people with Dyslipidemia, run by Eli Lilly and Company at 59 sites in 6 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 1 inclusion and 8 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 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 59 sites in United States, Netherlands, United Kingdom, Germany, Poland and 1 more country. 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 Mar 2018). 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 From Baseline to 12 Weeks Endpoint in High Density Lipoprotein Cholesterol (HDL-C) With LY2484595 in Combination With Atorvastatin and Atorvastatin Monotherapy (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. 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 NCT01105975, which also lists 3 linked publications.
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 Mar 2018.