NCT02289963

Brief Summary

Primary Objective: To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by alirocumab as add-on therapy to stable maximally tolerated daily statin therapy with or without other lipid-modifying therapy (LMT) in comparison with placebo after 24 weeks of treatment in high cardiovascular risk participants with hypercholesterolemia in South Korea and Taiwan. Secondary Objectives:

  • To evaluate the effect of alirocumab in comparison with placebo on LDL-C after 12 weeks of treatment.
  • To evaluate the effect of alirocumab on other lipid parameters: apolipoprotein B (Apo B), non high-density lipoprotein cholesterol (non-HDL-C), total cholesterol (TC), lipoprotein (a) (Lp \[a\]), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs), and apolipoprotein A-1 (Apo A-1).
  • To evaluate the safety and tolerability of alirocumab.
  • To evaluate the development of anti-alirocumab antibodies (ADA).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
199

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2015

Shorter than P25 for phase_3

Geographic Reach
2 countries

27 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 10, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 13, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

June 26, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

November 10, 2014

Results QC Date

April 24, 2017

Last Update Submit

June 22, 2017

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Percent Change From Baseline in Calculated LDL-C at Week 24 - Intent-to-Treat (ITT) Analysis

    Adjusted Least-squares (LS) means and standard errors at Week 24 were obtained from a mixed-effect model with repeated measures (MMRM) to account for missing data. All available post-baseline data up to Week 24 regardless of status on- or off-treatment were used in the model (ITT analysis).

    From Baseline to Week 24

Secondary Outcomes (21)

  • Percent Change From Baseline in Calculated LDL-C at Week 24 - On-Treatment Analysis

    From Baseline to Week 24

  • Percent Change From Baseline in Calculated LDL-C at Week 12 - ITT Analysis

    From Baseline to Week 24

  • Percent Change From Baseline in Calculated LDL-C at Week 12 - On-Treatment Analysis

    From Baseline to Week 24

  • Percent Change From Baseline in Apolipoprotein (Apo) B at Week 24 - ITT Analysis

    From Baseline to Week 24

  • Percent Change From Baseline in Apo B at Week 24 - On-treatment Analysis

    From Baseline to Week 24

  • +16 more secondary outcomes

Study Arms (2)

Placebo Q2W

PLACEBO COMPARATOR

Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.

Drug: Placebo (for Alirocumab)Drug: Lipid-Modifying Therapy (LMT)

Alirocumab 75 mg Q2W/Up to 150 mg Q2W

PLACEBO COMPARATOR

Alirocumab 75 mg SC injection Q2W added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.

Drug: AlirocumabDrug: Lipid-Modifying Therapy (LMT)

Interventions

Placebo (for Alirocumab)DRUG

Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.

Placebo Q2W
AlirocumabDRUG

Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.

Also known as: SAR236553, REGN727, Praluent®
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Lipid-Modifying Therapy (LMT)DRUG

Statins (Rosuvastatin, Simvastatin or Atorvastatin) at stable dose with or without other LMT as clinically indicated.

Alirocumab 75 mg Q2W/Up to 150 mg Q2WPlacebo Q2W

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants with hypercholesterolemia and established coronary heart disease (CHD) or CHD risk equivalents who are not adequately controlled with a maximally tolerated daily dose of statin with or without other LMT, both at stable dose for at least 4 weeks prior to screening visit (Week -3).

You may not qualify if:

  • Aged \<18 years or legal age of adulthood, whichever was greater.
  • Participants without established CHD or CHD risk equivalent.
  • LDL-C \<70 mg/dL (\<1.81 mmol/L) in participants with a history of documented cardiovascular disease.
  • LDL-C \<100 mg/dL (\<2.59 mmol/L) in participants without a history of documented cardiovascular disease.
  • Not on a stable dose of LMT (including statin) for at least 4 weeks prior to the screening visit (Week -3) or between screening to randomization visits.
  • Currently taking a statin other than atorvastatin, rosuvastatin or simvastatin.
  • Atorvastatin, rosuvastatin or simvastatin was not taken daily or not taken at a registered dose.
  • Daily doses above atorvastatin 80 mg, rosuvastatin 20 mg or simvastatin 40 mg.
  • Fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) at the screening period.
  • The above information is not intended to contain all considerations relevant to a participants's potential participation in a clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

Investigational Site Number 410001

Anyang, 431-070, South Korea

Location

Investigational Site Number 410009

Anyang-si, 431-070, South Korea

Location

Investigational Site Number 410017

Busan, 602-715, South Korea

Location

Investigational Site Number 410007

Busan, 614-735, South Korea

Location

Investigational Site Number 410002

Daegu, 700-712, South Korea

Location

Investigational Site Number 410011

Goyang-si, 410-773, South Korea

Location

Investigational Site Number 410003

Gwangju, 501-757, South Korea

Location

Investigational Site Number 410012

Incheon, 405-760, South Korea

Location

Investigational Site Number 410018

Jeonju, 561-712, South Korea

Location

Investigational Site Number 410006

Seoul, 06591, South Korea

Location

Investigational Site Number 410004

Seoul, 07061, South Korea

Location

Investigational Site Number 410015

Seoul, 08308, South Korea

Location

Investigational Site Number 410008

Seoul, 110-746, South Korea

Location

Investigational Site Number 410005

Seoul, 134-727, South Korea

Location

Investigational Site Number 410010

Seoul, 152-703, South Korea

Location

Investigational Site Number 410013

Ulsan, South Korea

Location

Investigational Site Number 158007

Changhua, 500, Taiwan

Location

Investigational Site Number 158005

Hsinchu, 30071, Taiwan

Location

Investigational Site Number 158011

Kaohsiung City, 807, Taiwan

Location

Investigational Site Number 158010

Kaohsiung City, 833, Taiwan

Location

Investigational Site Number 158006

Taichung, Taiwan

Location

Investigational Site Number 158008

Tainan, 704, Taiwan

Location

Investigational Site Number 158009

Tainan Hsien, 710, Taiwan

Location

Investigational Site Number 158001

Taipei, 100, Taiwan

Location

Investigational Site Number 158003

Taipei, 104, Taiwan

Location

Investigational Site Number 158002

Taipei, 112, Taiwan

Location

Investigational Site Number 158004

Taoyuan Hsien, Taiwan

Location

Related Publications (3)

  • Schmidt AF, Carter JL, Pearce LS, Wilkins JT, Overington JP, Hingorani AD, Casas JP. PCSK9 monoclonal antibodies for the primary and secondary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD011748. doi: 10.1002/14651858.CD011748.pub3.

    PMID: 33078867DERIVED

  • Chao TH, Hsiao PJ, Liu ME, Wu CJ, Chiang FT, Chen ZC, Chen CP, Yeh HI, Lee TH, Chiang CE. A subanalysis of Taiwanese patients from ODYSSEY South Korea and Taiwan study evaluating the efficacy and safety of alirocumab. J Chin Med Assoc. 2019 Apr;82(4):265-271. doi: 10.1097/JCMA.0000000000000062.

    PMID: 30946207DERIVED

  • Koh KK, Nam CW, Chao TH, Liu ME, Wu CJ, Kim DS, Kim CJ, Li I, Li J, Baccara-Dinet MT, Hsiao PJ, Chiang CE. A randomized trial evaluating the efficacy and safety of alirocumab in South Korea and Taiwan (ODYSSEY KT). J Clin Lipidol. 2018 Jan-Feb;12(1):162-172.e6. doi: 10.1016/j.jacl.2017.09.007. Epub 2017 Oct 19.

    PMID: 29153823DERIVED

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

alirocumab

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Results Point of Contact

Title
Trial Transparency Team
Organization
Sanofi
Contact-US@sanofi.com

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2014

First Posted

November 13, 2014

Study Start

January 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

June 26, 2017

Results First Posted

June 26, 2017

Record last verified: 2017-06

Locations

KR(16)TW(11)