Trial to Evaluate the Effect of ALN-PCSSC Treatment on Low Density Lipoprotein Cholesterol (LDL-C) (ORION-1)

A Placebo-controlled, Double-blind, Randomized Trial to Compare the Effect of Different Doses of ALN-PCSSC Given as Single or Multiple Subcutaneous Injections in Subjects With High Cardiovascular Risk and Elevated LDL-C

This study is a Phase II, placebo-controlled, double-blind, randomized trial in 480 participants with atherosclerotic cardiovascular disease (ASCVD) or ASCVD-risk equivalents (for example, diabetes and familial hypercholesterolemia) and elevated LDL-C despite maximum tolerated dose of LDL-C lowering therapies to evaluate the efficacy, safety, and tolerability of ALN-PCSSC injection(s).

Study Overview

• Status: Completed
• Conditions: Diabetes; Familial Hypercholesterolemia; Atherosclerotic Cardiovascular Disease
• Intervention / Treatment: Drug: ALN-PCSSC; Drug: Normal Saline

Detailed Description

Participants will be screened and 480 eligible participants will be randomized: 60 participants per each of six ALN-PCSSC dose groups plus 120 participants total across the placebo groups (20 participants each to match each of the six drug dose groups). Treatment allocation will be stratified by country and by current use of statins or other lipid-modifying therapies. Each participant will receive either one or two injections on Day 1 or a single injection on Day 1 and on Day 90 of blinded ALN-PCSSC or placebo.

Formation of anti-drug antibodies (ADA) will be assessed on Day 1 (prior to and 4 hours after the injection) and on Days 30, 60, 90, 120, 150, 180 (Days 150 and 180 only in participants who receive a second dose of study drug), and 210 or until any ADA response becomes negative within the study duration.

The independent Data Monitoring Committee (DMC) will review safety data beginning after the first 40 participants receive the first injection of ALN-PCSSC or placebo and complete the Day 14 follow-up visit. Thereafter, the DMC will review safety data every 2 months until the end of the trial. A recommendation may be taken to stop or amend the study at any of these reviews.

On Day 1, all eligible participants will be randomized and receive the first subcutaneous (SC) administration of ALN-PCSSC or placebo. After the first study drug administration, the participant will be observed in the clinic for at least 4 hours post injection before being discharged. Participants will return at Day 14 and then at monthly intervals for 6 months. Participants randomized to receive a second dose of study drug will receive the second injection of ALN-PCSSC or placebo at the Day 90 visit.

Efficacy assessments will include the measurement of the effects of ALN-PCSSC on levels of LDL-C lipids and lipoproteins including total cholesterol (TC), triglycerides, high-density lipoprotein cholesterol (HDL-C), non-HDL-C, very low-density lipoprotein (VLDL), apolipoprotein A1 (Apo-AI), apolipoprotein B (Apo-B), lipoprotein (a) [Lp(a)], C-reactive protein (CRP), and proprotein convertase subtilisin/kexin type 9 (PCSK9).

End of study (EOS) evaluations will be conducted at the EOS visit (Day 210). The expected duration of the participants' involvement in the study will be approximately 374 days, which includes screening, study drug administration, the course of single or multiple injections, and the follow-up period to Day 360.

Participants completing the study to Day 210 will be given the opportunity to enroll in a separate long-term extension study. Any participants in whom LDL-C levels have not returned to >80% of baseline values will continue to be followed as part of this study until either this level has been reached or until a maximum of Day 360, at which point they will be given the opportunity to enroll in the long-term extension study. At each visit, LDL-C levels, adverse events, serious adverse events, concomitant medications, and safety laboratory assessments will be collected.

Objectives:

Primary:

To evaluate the effect of ALN-PCSSC treatment on LDL-C levels at Day 180.

Secondary:

To evaluate the effect of ALN-PCSSC on the following:

• LDL-C at Day 90
• LDL-C levels at other time points
• PCSK9 levels over time
• Other lipids, lipoproteins, apolipoproteins
• Proportion of participants achieving pre-specified global lipid guidelines
• Individual responsiveness to different doses
• Duration of lipid-lowering effect of different doses
• Safety and tolerability profile of ALN-PCSSC

Exploratory:

To collect/evaluate the effect of ALN-PCSSC on the following:

• Cardiovascular (CV) events such as CV death, non-fatal myocardial infarction, resuscitated cardiac arrest and non-fatal stroke (ischemic and hemorrhagic)
• Evaluation of ADA for the investigational product

• Study Type: Interventional
• Enrollment (Actual): 501
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • St. Boniface Hospital
  • Newfoundland and Labrador
    • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
      • Eastern Regional Health Authority, Patient Research Centre
  • Ontario
    • Brampton, Ontario, Canada, L6Z 4N5
      • Brampton Research Associates
    • London, Ontario, Canada, N6C 2R5
      • Lawson Health Research Institute
    • Toronto, Ontario, Canada, M5C 2T2
      • St. Michael's Hospital
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 7K9
      • ECOGENE-21 Clinical Trials Center
    • Montreal, Quebec, Canada, H2W 1R7
      • Institut de recherches cliniques de Montreal
    • Montreal, Quebec, Canada, H1T 3Y7
      • Clinic Sante Cardio MC
    • Quebec City, Quebec, Canada, G1V 4G5
      • Université Laval Quebec
    • Quebec City, Quebec, Canada, G1V 4W2
      • Clinique des maladies lipidique Quebec
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitaire de Sherbrooke (CIUSSS de l'Estrie - CHUS)
• Germany
  • Berlin, Germany, 12203
    • Medical University Berlin
  • Essen, Germany, 45355
    • Medical Center Essen
  • Frankfurt, Germany, 60590
    • University Hospital Frankfurt
  • Hamburg, Germany, 20251
    • University Heart Center Hamburg
  • Heidelberg, Germany, 69120
    • Medical University Hospital Heidelberg, Internal Medicine III
  • Munich, Germany, 80636
    • Technical University Munich, German Heart Center
• Netherlands
  • Amsterdam, Netherlands, 1105 AZ
    • Amsterdam Medical Center
  • Den Haag, Netherlands, 2545 CH
    • Haga hospital
  • Deventer, Netherlands, 7416 SE
    • Deventer Ziekenhuis
  • Eindhoven, Netherlands, 5611 NV
    • Andromed Eindhoven
  • Goes, Netherlands, 4462 RA
    • Admiraal de Ruyter Hospital, Cardiology
  • Hoogeveen, Netherlands, 7909 AA
    • Bethesda Diabetes Research Center
  • Hoogezand, Netherlands, 9603 AE
    • Medisch Centrum Gorecht
  • Hoorn, Netherlands, 0031229284320
    • VOC Hoorn
  • Leiden, Netherlands, 2333 ZA
    • Leids Universitair Medisch Centrum (LUMC)
  • Rotterdam, Netherlands, 3021 HC
    • Andromed Rotterdam
  • Utrecht, Netherlands, 3584 CX
    • UMC Utrecht
  • Utrecht, Netherlands, 3582 KE
    • Diakonessenhuis, Vascular Policlinic
  • Venlo, Netherlands, 5912 BL
    • VieCurie Venlo, Cardiology
  • Zwijndrecht, Netherlands, 3331 LZ
    • Albert Schweitzer Hospital, Cardiology
• United Kingdom
  • Birmingham, United Kingdom, B15 2TH
    • Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust
  • Edinburgh, United Kingdom, EH16 4SA
    • Edinburgh Royal Infirmary
  • Exeter, United Kingdom, EX2 5DW
    • The Royal Devon and Exeter NHS Trust
  • Fowey, United Kingdom, PL23 1DT
    • Fowey River Practice
  • High Wycombe, United Kingdom, HP11 2TT
    • Buckinghamshire NHS Trust
  • Liskeard, United Kingdom, Oak Tree Surgery
    • Oak Tree Surgery
  • London, United Kingdom, Nw3 2QG
    • Royal Free Hospital
  • Manchester, United Kingdom, M13 9WL
    • Central Manchester University Hospital NHS Foundation Trust
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Freeman Hospital
  • Penzance, United Kingdom, TR18 4JH
    • The Alverton Practice
  • Plymouth, United Kingdom, PL5 3JB
    • Knowle House Surgery
  • St. Austell, United Kingdom, St. Austell
    • Brannel Surgery
  • Torpoint, United Kingdom, PL11 2TB
    • Rame Medical Ltd (Rame Research)
  • Worcester, United Kingdom, WR5 1DD
    • Worcestershire Acute NHS Trust
• United States
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Center for Clinical Research
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Institute for Clinical Research
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Icahn School of Medicine
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Metabolic and Atherosclerosis Research Center
    • Cincinnati, Ohio, United States, 45246
      • Sterling Research Group
  • Tennessee
    • Greeneville, Tennessee, United States, 37745
      • Wellmont CVA Heart Institute
  • Texas
    • Amarillo, Texas, United States, 79106
      • Amarillo Heart Clinical Research Institute, Inc.
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female participants ≥18 years of age.
2. History of ASCVD or ASCVD-risk equivalents (symptomatic atherosclerosis, Type 2 diabetes, familial hypercholesterolemia, including participants whose 10-year risk of a CV event assessed by Framingham Risk Score (Framingham Risk Score >20%) or equivalent has a target LDL-C of <100 mg/deciliter [dL]).
3. Serum LDL-C ≥1.8 millimole (mmol)/liter (L) (≥70 mg/dL) for ASCVD participants or ≥2.6 mmol/L (≥100 mg/dL) for ASCVD-risk equivalent participants at screening.
4. Fasting triglyceride <4.52 mmol/L (<400 mg/dL) at screening.
5. Calculated glomerular filtration rate 30 mL/min or higher by estimated glomerular filtration rate (eGFR) using standardized local clinical methodology.
6. Participants on statins should be receiving a maximally tolerated dose (investigator's discretion).
7. Participants on lipid-lower therapies (such as statin and/or ezetimibe) should be on a stable dose for ≥30 days before screening with no planned medication or dose change during study participation.
8. Willing and able to give informed consent before initiation of any study-related procedures and willing to comply with all required study procedures.

Exclusion Criteria:

1. Any uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and/or put the participant at significant risk (according to investigator's [or delegate] judgment) if he/she participates in the clinical study.
2. An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate), might interfere with interpretation of the clinical study results.
3. New York Heart Association (NYHA) class II, III, or IV heart failure or last known left ventricular ejection fraction <30%.
4. Cardiac arrhythmia within 3 months prior to randomization that is not controlled by medication or via ablation.
5. Any history of hemorrhagic stroke.
6. Major adverse cardiac event within 6 months prior to randomization.
7. Uncontrolled severe hypertension: systolic blood pressure >180 millimeters of mercury (mmHg) or diastolic blood pressure >110 mmHg prior to randomization despite anti-hypertensive therapy.
8. Poorly controlled Type 2 diabetes, such as, glycated hemoglobin A1c (HbA1c)>10.0% prior to randomization.
9. Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained alanine aminotransferase (ALT) or aspartate aminotransferase (AST) elevation >2x the upper limit of normal (ULN), or total bilirubin elevation >1.5x ULN at screening confirmed by a repeat measurement at least 1 week apart.
10. Serious comorbid disease in which the life expectancy of the participant is shorter than the duration of the trial (for example, acute systemic infection, cancer, or other serious illnesses). This includes all cancers with the exception of treated basal-cell carcinoma occurring >5 years before screening.
11. Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, intrauterine device or tubal litigation) for the entire duration of the study. Women who are >2 years postmenopausal defined as ≥1 year since last menstrual period and if less than 55 years old with a negative pregnancy test within 24 hours of randomization or surgically sterile are exempt from this exclusion.
12. Males who are unwilling to use an acceptable method of birth control during the entire study period (such as, condom with spermicide).
13. Known history of alcohol and/or drug abuse within the last 5 years.
14. Treatment with other investigational medicinal products or devices within 30 days or five half˗lives, whichever is longer.
15. Use of other investigational medicinal products or devices during the course of the study.

16. Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to the following:

    • Inappropriate for this study, including participants who are unable to communicate or to cooperate with the investigator.
    • Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including participants whose cooperation is doubtful due to drug abuse or alcohol dependency).
    • Unlikely to comply with the protocol requirements, instructions, and study-related restrictions (for example, uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).
    • Have any medical or surgical condition, which in the opinion of the investigator would put the participants at increased risk from participating in the study.
    • Involved with, or a relative of, someone directly involved in the conduct of the study.
    • Any known cognitive impairment (for example, Alzheimer's disease)
17. Previous or current treatment (within 90 days of screening) with monoclonal antibodies directed at PCSK9.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALN-PCSSC 200 mg (bi-annual dosing); ALN-PCSSC 200 milligram (mg) SC administration once at Day 1	Drug: ALN-PCSSC; ALN-PCSSC is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis and is given as SC injections; Other Names: PCSK9 synthesis inhibitor; Inclisiran
Experimental: ALN-PCSSC 300 mg (bi-annual dosing); ALN-PCSSC 300 mg SC administration once at Day 1	Drug: ALN-PCSSC; ALN-PCSSC is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis and is given as SC injections; Other Names: PCSK9 synthesis inhibitor; Inclisiran
Experimental: ALN-PCSSC 500 mg (bi-annual dosing); ALN-PCSSC 500 mg SC administration once at Day 1	Drug: ALN-PCSSC; ALN-PCSSC is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis and is given as SC injections; Other Names: PCSK9 synthesis inhibitor; Inclisiran
Placebo Comparator: Normal Saline (bi-annual dosing); Saline SC administration once at Day 1	Drug: Normal Saline; Saline (sterile, normal, 0.9%) solution given as SC injections
Experimental: ALN-PCSSC 100 mg (quarterly dosing); ALN-PCSSC 100 mg SC administration twice at Day 1 and Day 90	Drug: ALN-PCSSC; ALN-PCSSC is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis and is given as SC injections; Other Names: PCSK9 synthesis inhibitor; Inclisiran
Experimental: ALN-PCSSC 200 mg (quarterly dosing); ALN-PCSSC 200 mg SC administration twice at Day 1 and Day 90	Drug: ALN-PCSSC; ALN-PCSSC is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis and is given as SC injections; Other Names: PCSK9 synthesis inhibitor; Inclisiran
Experimental: ALN-PCSSC 300 mg (quarterly dosing); ALN-PCSSC 300 mg SC administration twice at Day 1 and Day 90	Drug: ALN-PCSSC; ALN-PCSSC is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis and is given as SC injections; Other Names: PCSK9 synthesis inhibitor; Inclisiran
Placebo Comparator: Normal Saline (quarterly dosing); Saline SC administration twice at Day 1 and Day 90	Drug: Normal Saline; Saline (sterile, normal, 0.9%) solution given as SC injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in LDL-C From Baseline to Day 180	Percent Change in LDL-C (beta-quantification) from Baseline to Day 180 in MITT Population	Baseline to 180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage Change in LDL-C From Baseline to Day 90	Percent Change in LDL-C (beta-quantification) from Baseline to Day 90 in MITT Population	Baseline to 90 days
Percent Change From Baseline In LDL-C Levels At Day 60, Day 120, and Day 210	This outcome measure evaluated the effects of both single- and double-dose inclisiran on LDL-C levels in the mITT population from baseline to Day 60, Day 120, and Day 210.	Baseline, Day 60, Day 120, and Day 210
Number of Participants With an LDL-C Greater Than 80% of the Baseline Value at Day 180 and Day 210	This outcome measure evaluated the number of participants (single and double dose) in the mITT population with an LDL-C greater than 80% of the baseline value at Day 180 and Day 210.	Baseline, Day 180, Day 210
Number of Participants With Individual Responsiveness as Measured By LDL-C Levels at Day 90 and Day 180	This outcome measure evaluated the individual responsiveness of participants to inclisiran (single and double dose) in the mITT population as defined by an LDL-C level of <25 mg/deciliter [dL] at Day 90 and Day 180.	Day 90, Day 180
Number of Participants With Greater Or Equal To 50% LDL-C Reduction From Baseline At Day 180	This outcome measure evaluated the number of participants (single and double dose) in the mITT population with an LDL-C reduction greater than 50% of the baseline value at Day 180.	Baseline, Day 180
Percentage Change in PCSK9 Levels From Baseline at Day 180	This outcome measure evaluated the percent change in proprotein convertase subtilisin/kexin type 9 (PCSK9) from baseline to Day 180 in participants (single and double dose) in the mITT population.	Baseline, Day 180
Percentage Change in Other Lipids and Apolipoproteins From Baseline to Day 180	This outcome measure evaluated the percent change from baseline to Day 180 in cholesterol (total, high-density lipoprotein [HDL], non-HDL) and apolipoproteins (B, A1) in participants (single and double dose) in the mITT population.	Baseline, Day 180
Number of Participants Who Attained Global Lipid Modification Targets for Level of Atherosclerotic Cardiovascular Disease Risk	This outcome measure evaluated the proportion of participants (single and double dose) in the mITT population who attained a global lipid modification target by baseline cardiovascular risk group, looking specifically at LDL-C levels (mg/dL) in the category of cardiovascular disease (CVD). CVD was defined as a participant who had at least 1 of the following: prior myocardial infarction, prior percutaneous coronary intervention, prior coronary artery bypass graft, prior stroke, prior transient ischemic attack, peripheral artery disease.	Baseline, Day 180
Percentage Change in Other Lipids and Inflammatory Markers From Baseline to Day 180	This outcome measure evaluated the percent change from baseline to Day 180 in triglycerides, very-low-density lipoprotein (VLDL) cholesterol, lipoprotein(a), and high sensitivity C-reactive protein (hsCRP) in participants (single and double dose) in the mITT population.	Baseline, Day 180

Collaborators and Investigators

• Sponsor: The Medicines Company
• Investigators: Principal Investigator: Kausik K Ray, MD, Department of Public Health and Primary Care, Imperial College London, Reynolds Building

Publications and helpful links

General Publications

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• Cohen JC, Boerwinkle E, Mosley TH Jr, Hobbs HH. Sequence variations in PCSK9, low LDL, and protection against coronary heart disease. N Engl J Med. 2006 Mar 23;354(12):1264-72. doi: 10.1056/NEJMoa054013.
• Davidson MH, Maki KC, Pearson TA, Pasternak RC, Deedwania PC, McKenney JM, Fonarow GC, Maron DJ, Ansell BJ, Clark LT, Ballantyne CM. Results of the National Cholesterol Education (NCEP) Program Evaluation ProjecT Utilizing Novel E-Technology (NEPTUNE) II survey and implications for treatment under the recent NCEP Writing Group recommendations. Am J Cardiol. 2005 Aug 15;96(4):556-63. doi: 10.1016/j.amjcard.2005.04.019.
• Dias CS, Shaywitz AJ, Wasserman SM, Smith BP, Gao B, Stolman DS, Crispino CP, Smirnakis KV, Emery MG, Colbert A, Gibbs JP, Retter MW, Cooke BP, Uy ST, Matson M, Stein EA. Effects of AMG 145 on low-density lipoprotein cholesterol levels: results from 2 randomized, double-blind, placebo-controlled, ascending-dose phase 1 studies in healthy volunteers and hypercholesterolemic subjects on statins. J Am Coll Cardiol. 2012 Nov 6;60(19):1888-98. doi: 10.1016/j.jacc.2012.08.986. Epub 2012 Oct 17.
• Elbashir SM, Harborth J, Lendeckel W, Yalcin A, Weber K, Tuschl T. Duplexes of 21-nucleotide RNAs mediate RNA interference in cultured mammalian cells. Nature. 2001 May 24;411(6836):494-8. doi: 10.1038/35078107.
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• ALN TTRSC-001; EudraCT 2012 004203 12
• ALN-TTRSC-002; EudraCT 2013 002856 33
• Geisbert TW, Hensley LE, Kagan E, Yu EZ, Geisbert JB, Daddario-DiCaprio K, Fritz EA, Jahrling PB, McClintock K, Phelps JR, Lee AC, Judge A, Jeffs LB, MacLachlan I. Postexposure protection of guinea pigs against a lethal ebola virus challenge is conferred by RNA interference. J Infect Dis. 2006 Jun 15;193(12):1650-7. doi: 10.1086/504267. Epub 2006 May 10.
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• Morrissey DV, Lockridge JA, Shaw L, Blanchard K, Jensen K, Breen W, Hartsough K, Machemer L, Radka S, Jadhav V, Vaish N, Zinnen S, Vargeese C, Bowman K, Shaffer CS, Jeffs LB, Judge A, MacLachlan I, Polisky B. Potent and persistent in vivo anti-HBV activity of chemically modified siRNAs. Nat Biotechnol. 2005 Aug;23(8):1002-7. doi: 10.1038/nbt1122. Epub 2005 Jul 24.
• Mousavi SA, Berge KE, Leren TP. The unique role of proprotein convertase subtilisin/kexin 9 in cholesterol homeostasis. J Intern Med. 2009 Dec;266(6):507-19. doi: 10.1111/j.1365-2796.2009.02167.x.
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Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 7, 2017
• Study Completion (Actual): June 7, 2017

Study Registration Dates

• First Submitted: November 3, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2019
• Last Update Submitted That Met QC Criteria: April 23, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Genetic Diseases, Inborn; Metabolism, Inborn Errors; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Lipid Metabolism, Inborn Errors; Hyperlipoproteinemias; Cardiovascular Diseases; Hypercholesterolemia; Atherosclerosis; Hyperlipoproteinemia Type II
• Other Study ID Numbers: MDCO-PCS-15-01