HypercholesterolemiaPhase 2NCT01890967
A Study of LY3015014 in Participants With High Cholesterol
A Phase 2 study testing LY3015014, Statin and Ezetimibe in people with Hypercholesterolemia, run by Eli Lilly and Company at 49 sites in 8 countries.
Trial summary
This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- LY3015014, Statin and Ezetimibe
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 527 participants
- Where
- 49 sitesin 8 countries
- Study dates
- Jun 2013to Jun 2014
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with high low density lipoprotein (LDL) cholesterol
- Are on stable daily dose of a statin or have a history of statin intolerance
- Men with a partner who can become pregnant must agree to use barrier protection during sexual intercourse to prevent pregnancies
- Women who cannot become pregnant, or women who are not pregnant or breast feeding and agree to use a reliable method of birth control to prevent pregnancies
Who cannot join
- Have high cholesterol due to another disease or have a rare and serious form of hereditary high cholesterol
- Have had recent heart attack, stroke, blood clot or heart surgery, have planned heart or blood vessel surgery, or has a heart that does not pump sufficiently well
- Have poorly controlled high blood pressure
- Have diabetes that requires an injectable medication (including insulin), or have diabetes that is poorly controlled
- Have thyroid blood test that is outside normal range
- Have a history of adrenal gland disorder
Show all 26Show fewer
- Have a history of vitamin E deficiency or fat malabsorption syndrome
- Have poor kidney function
- Have active liver or gall bladder disease, history of hepatitis or liver blood tests that are high
- Have a history of muscle disease including muscle damage from a medicine or muscle blood test that is high
- Are anemic (low red blood cell counts)
- Have a history of allergy or intolerance to other antibody medications
- Have a history of human immunodeficiency virus infection (HIV) infection
- Are likely to have a major operation or be hospitalized during the study
- Have chronic alcohol or drug abuse or dependency
- Have or suspected to have any cancer or malignant tumor
- Have an active serious infection
- Have started or stopped taking a statin or ezetimibe medication, or changed statin dose regimen recently
- Are on a statin regimen other than daily dosing (for example, an every-other-day statin regimen)
- Have recently used simvastatin (highest dose level), fibrates, bile acid binders, niacin, probucol, or over-the-counter/health food preparations to lower cholesterol (such as red yeast rice, fish oil, omega 3 fatty acid)
- Have undergone LDL apheresis in the past 1 year
- Have recently used steroids, cyclosporine or isotretinoin
- Have recently used an immunosuppressive therapy
- Have recently received treatment with another antibody medication
- Are currently using medications injected into the skin , except for single injections (for example flu vaccines) or injections into muscles
- Are currently on a prescription or over-the-counter medicine for weight loss or are on a very low carbohydrate diet
Trial locations and contacts
49 sites in 8 countries.
49 sites in 8 countries
United States15 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.
Aurora, Colorado, 80012
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Bossier City, Louisiana, 71111
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Charlotte, North Carolina, 28205
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Cincinnati, Ohio, 45227
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Encino, California, 91436
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Indianapolis, Indiana, 46290
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Iowa City, Iowa, 52242
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Knoxville, Tennessee, 37920
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Lancaster, California, 93534
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Louisville, Kentucky, 40213
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Raleigh, North Carolina, 27609
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Safety Harbor, Florida, 34695
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Spring Valley, California, 91978
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Tampa, Florida, 33613
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Toledo, Ohio, 43615
Canada8 sites
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Brampton, Ontario, L6T 0G1
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Gatineau, Quebec, J8Y 6S8
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Kamloops, British Columbia, V2C 1K7
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Kelowna, British Columbia, V1Y3G5
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London, Ontario, N6A 5K8c
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Montreal, Quebec, H1T 1C8
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Saint-Marc-des-Carrieres, Quebec, G0A 4B0
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Toronto, Ontario, M4G 3E8
Netherlands8 sites
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Amsterdam, 1105 AZ
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Breda, 4811 SW
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Goes, 4462 RA
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Groningen, 9711 SG
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Maastricht, 6229 HX
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Nijmegen, 6525 HB
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Rotterdam, 3021 HC
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Utrecht, 3584 CX
Denmark5 sites
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Aalborg, DK-9000
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Copenhagen, 2100 CPH
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Esbjerg, 6700
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Hellerup, 2900
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Hvidovre, 2650
Poland5 sites
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Bialystok, 15-351
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Gdansk, 80-546
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Krakow, 30-015
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Lodz, 90-242
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Lublin, 20-582
Czechia4 sites
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Český Krumlov, 381 01
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Hodonín, 695 01
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Prague, 150 06
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Svitavy, 568 25
Japan3 sites
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Fukuoka, 819-0375
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Osaka, 530-0001
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Tokyo, 171-0033
Puerto Rico1 site
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Ponce, 00717-1322
About this study
Official title: A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With Primary Hypercholesterolemia
This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.
- Conditions
- Hypercholesterolemia
- Being tested
- LY3015014, Placebo, Statin, Ezetimibe
- Keywords
- low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3015014Drug
Administered SC
PlaceboDrug
Administered SC
StatinDrug
Also called atorvastatin, simvastatin, rosuvastatin, pravastatin
Administered orally
EzetimibeDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| 20 mg LY3015014 Q4W | Experimental | 20 milligrams (mg) LY3015014 given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. Receives: Drug: LY3015014; Drug: Statin; Drug: Ezetimibe |
| 120 mg LY3015014 Q4W | Experimental | 120 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. Receives: Drug: LY3015014; Drug: Statin; Drug: Ezetimibe |
| 300 mg LY3015014 Q4W | Experimental | 300 mg LY3015014 given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. Receives: Drug: LY3015014; Drug: Statin; Drug: Ezetimibe |
| 100 mg LY3015014 Q8W | Experimental | 100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. Receives: Drug: LY3015014; Drug: Statin; Drug: Ezetimibe |
| 300 mg LY3015014 Q8W | Experimental | 300 mg LY3015014 given SC Q8W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. Receives: Drug: LY3015014; Drug: Statin; Drug: Ezetimibe |
| Placebo Q4W | Placebo comparator | Placebo given SC Q4W for 16 weeks.
Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. Receives: Drug: Placebo; Drug: Statin; Drug: Ezetimibe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.
Measured: Baseline, Week 16
Secondary outcomes (9)
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
LS Mean was calculated using mixed model repeated measures (MMRM) analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Measured: Baseline, Week 16
Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Measured: Baseline, Week 16
Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]
Data was log-transformed for MMRM analysis, with change from baseline as the dependent variable, and baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included as independent variables. Percentage change from baseline in the original scale was then back-calculated from the log-transformed MMRM analysis.
Measured: Baseline, Week 16
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Measured: Baseline, Week 16
Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies
Measured: Baseline through Week 24
Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Measured: Baseline, Week 16
Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
LS Mean was calculated using MMRM analysis with baseline measurement, disease classification, statin dose, treatment, visit, and treatment by visit interaction included in the model. Percent change from baseline response is the dependent variable.
Measured: Baseline, Week 16
Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014
Measured: Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose
Number of Participants With an Injection Site Reaction
Measured: Baseline through Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2013 (estimated)
- Study startJun 2013
- Primary completionApr 2014
- Study completionJun 2014
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 HypercholesterolemiaStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 527 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
- NCT01890967
- Sponsor's protocol ID
- 14853
- Other IDs
- I5S-MC-EFJE
- Status last verified
- Sep 2019
- First submitted
- 27 Jun 2013
- Last updated
- 18 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Efficacy and Safety Dose-Ranging Study of LY3015014 in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT01890967
- Acronym / sponsor ID
- 14853
- Conditions
- Hypercholesterolemia
- Keywords
- low density lipoprotein, heterozygous familial hypercholesterolemia, polygenic hypercholesterolemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 2 Jul 2013 (estimated)
- Results
- Posted 21 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to define the amount and duration of cholesterol lowering and to assess the safety and tolerability of different dose regimens of LY3015014 in participants with high cholesterol. The study will also investigate how the body processes the drug and how the drug affects the body. Participants will remain on a stable diet and will continue taking cholesterol-lowering medications (statins with or without ezetimibe). After signing the informed consent document, the participant will complete a screening/run-in period that will last at most 8 weeks. Then, the treatment period will last approximately 16 weeks. After the treatment period, the participants will complete a follow-up period lasting approximately 8 weeks for a total study duration ranging from approximately 25 to 32 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 20 mg LY3015014 Q4W | Experimental | Drug: LY3015014, Drug: Statin, Drug: Ezetimibe20 milligrams (mg) LY3015014 given subcutaneously (SC) once every 4 weeks (Q4W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 120 mg LY3015014 Q4W | Experimental | Drug: LY3015014, Drug: Statin, Drug: Ezetimibe120 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 300 mg LY3015014 Q4W | Experimental | Drug: LY3015014, Drug: Statin, Drug: Ezetimibe300 mg LY3015014 given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 100 mg LY3015014 Q8W | Experimental | Drug: LY3015014, Drug: Statin, Drug: Ezetimibe100 mg LY3015014 given SC once every 8 weeks (Q8W) for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| 300 mg LY3015014 Q8W | Experimental | Drug: LY3015014, Drug: Statin, Drug: Ezetimibe300 mg LY3015014 given SC Q8W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
| Placebo Q4W | Placebo comparator | Drug: Placebo, Drug: Statin, Drug: EzetimibePlacebo given SC Q4W for 16 weeks. Participants will remain on stable diet and physician-prescribed statin therapy, if tolerated, with or without ezetimibe. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with high low density lipoprotein (LDL) cholesterol
- Are on stable daily dose of a statin or have a history of statin intolerance
- Men with a partner who can become pregnant must agree to use barrier protection during sexual intercourse to prevent pregnancies
- Women who cannot become pregnant, or women who are not pregnant or breast feeding and agree to use a reliable method of birth control to prevent pregnancies
Key exclusion criteria (26 listed)
- Have high cholesterol due to another disease or have a rare and serious form of hereditary high cholesterol
- Have had recent heart attack, stroke, blood clot or heart surgery, have planned heart or blood vessel surgery, or has a heart that does not pump sufficiently well
- Have poorly controlled high blood pressure
- Have diabetes that requires an injectable medication (including insulin), or have diabetes that is poorly controlled
- Have thyroid blood test that is outside normal range
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 |
|---|---|---|
| LY3015014Administered SC | Drug | 100 mg LY3015014 Q8W, 120 mg LY3015014 Q4W, 20 mg LY3015014 Q4W, 300 mg LY3015014 Q4W, 300 mg LY3015014 Q8W |
| PlaceboAdministered SC | Drug | Placebo Q4W |
| StatinAlso: atorvastatin, simvastatin, rosuvastatin, pravastatinAdministered orally | Drug | 100 mg LY3015014 Q8W, 120 mg LY3015014 Q4W, 20 mg LY3015014 Q4W, 300 mg LY3015014 Q4W, 300 mg LY3015014 Q8W, Placebo Q4W |
| EzetimibeAdministered orally | Drug | 100 mg LY3015014 Q8W, 120 mg LY3015014 Q4W, 20 mg LY3015014 Q4W, 300 mg LY3015014 Q4W, 300 mg LY3015014 Q8W, Placebo Q4W |
Primary outcome
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C)
Time frame: Baseline, Week 16
Least square (LS) Means was calculated using analysis of covariance (ANCOVA) adjusted for disease classification, statin dose, baseline LDL-C measurement. Percent change from baseline response is the dependent variable.
9 secondary outcomes
Percentage Change From Baseline in LDL-C, Total Cholesterol (TC), High-Density Lipoprotein Cholesterol (HDL-C), Triglycerides (TG), Non-HDL-C
Time frame: Baseline, Week 16
Percentage Change From Baseline in Apolipoprotein A1 (Apo A1), Apolipoprotein B (Apo B)
Time frame: Baseline, Week 16
Percentage Change From Baseline in Lipoprotein(a) [Lp(a)]
Time frame: Baseline, Week 16
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline, Week 16
Number of Participants Who Develop Treatment Emergent Anti-LY3015014 Antibodies
Time frame: Baseline through Week 24
Percentage Change From Baseline in Total Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
Time frame: Baseline, Week 16
Percentage Change From Baseline in Free Proprotein Convertase Subtilisin/Kexin Type 9 Antibody (PCSK9) Levels
Time frame: Baseline, Week 16
Pharmacokinetics (PK): Area Under the Concentration-Time Curve at Steady-State (AUC,ss) for LY3015014
Time frame: Week 12-16 (Q4W) - Predose, Week 8-16 (Q8W) - Predose
Number of Participants With an Injection Site Reaction
Time frame: Baseline through Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
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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
49 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LY3015014, Statin and Ezetimibe in people with Hypercholesterolemia, run by Eli Lilly and Company at 49 sites in 8 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 26 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 18 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in United States, Canada, Netherlands, Denmark, Poland and 3 more countries. 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 21 Jun 2017). 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?
Percentage Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) (time frame: Baseline, Week 16). 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 18 Sep 2019.