Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS (dal-GenE-2)

Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)

This is a placebo-controlled, randomized, double-blind, parallel group, phase 3 multicenter study in subjects recently hospitalized for ACS and with the appropriate genetic profile. Subjects will provide informed consent before any study-specific procedures are performed. A separate informed consent will be allowed for an initial pre-screening genetic testing. Subjects meeting the AA genotype will then consent to the full study and confirmatory genetic testing as required. Subject enrollment may begin in the hospital and will continue following release from the hospital or may begin following release from hospital. Screening procedures may be performed at the time of the index ACS event or anytime thereafter, with the condition that randomization must occur within the mandated window (up to12 weeks after the index event). Subjects will be assessed based on their medical history. Those who are likely to qualify will undergo Genotype Assay testing to evaluate genetic determination for the presence of AA genotype.

Study Overview

• Status: Recruiting
• Conditions: Acute Coronary Syndrome
• Intervention / Treatment: Drug: Placebo; Drug: Dalcetrapib

Detailed Description

This is an event-driven study and will last until approximately 200 subjects have experienced a primary event, unless the study is stopped at the planned interim analysis. Visits after randomization will be performed as virtual visits where permissible every 3 months or as clinic visits until the study is stopped. For any subject prematurely discontinuing study medication, assessments will be conducted every 3 months for the collection of study endpoints.

Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination or the presence of the AA genotype at variant rs 1967309 in the ADCY9 gene as determined by the investigational use only version of the cobas ADCY9 Genotype Test, conducted at a designated investigational testing site.

• Study Type: Interventional
• Enrollment (Estimated): 2000
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: David Kallend, MBBS; Phone Number: +41 79 174 1830; Email: dkallend@dalcorpharma.com
• Study Contact Backup: Name: Therese Heinonen, DVM; Email: theinonen@dalcorpharma.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y0B3
      • Not yet recruiting
      • Research Site
    • Edmonton, Alberta, Canada, T6G 2B7
      • Not yet recruiting
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  • British Columbia
    • Abbotsford, British Columbia, Canada, V2S 0C2
      • Not yet recruiting
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    • Burnaby, British Columbia, Canada, V5G 2X6
      • Not yet recruiting
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    • Kamloops, British Columbia, Canada, V2C2T1
      • Not yet recruiting
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    • North Vancouver, British Columbia, Canada, V7M 2H4
      • Recruiting
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    • Surrey, British Columbia, Canada, V3V0C6
      • Not yet recruiting
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    • Vancouver, British Columbia, Canada
      • Not yet recruiting
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    • Victoria, British Columbia, Canada
      • Not yet recruiting
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  • Manitoba
    • Winnipeg, Manitoba, Canada, R2H 2A6
      • Recruiting
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  • New Brunswick
    • Moncton, New Brunswick, Canada, E1G 1A7
      • Recruiting
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    • Moncton, New Brunswick, Canada, E1C 2Z3
      • Recruiting
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  • New Foundland
    • Saint John's, New Foundland, Canada, A1B 3V6
      • Recruiting
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  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H3A7
      • Not yet recruiting
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  • Ontario
    • Brampton, Ontario, Canada, L6R3J7
      • Not yet recruiting
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    • Cambridge, Ontario, Canada, N1R 6V6
      • Recruiting
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    • Cambridge, Ontario, Canada, N1R 7R1
      • Not yet recruiting
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    • Kingston, Ontario, Canada, K7L2V7
      • Not yet recruiting
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    • London, Ontario, Canada, N6A 5A5
      • Recruiting
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    • Newmarket, Ontario, Canada, L3Y 2R2
      • Not yet recruiting
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    • Ottawa, Ontario, Canada, K1Y4W7
      • Not yet recruiting
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    • Scarborough, Ontario, Canada, M1B 4Z8
      • Recruiting
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    • Scarborough, Ontario, Canada, M1B 5N1
      • Recruiting
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    • Toronto, Ontario, Canada, M4N 3M5
      • Not yet recruiting
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    • Toronto, Ontario, Canada, M5G2C4
      • Not yet recruiting
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    • Toronto, Ontario, Canada, M5D 1W8
      • Not yet recruiting
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  • Quebec
    • Chicoutimi, Quebec, Canada
      • Recruiting
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    • Granby, Quebec, Canada, J2G 1T7
      • Not yet recruiting
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    • Laval, Quebec, Canada, H7M 3L9
      • Recruiting
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    • Lévis, Quebec, Canada
      • Recruiting
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    • Montréal, Quebec, Canada, H1T1C8
      • Recruiting
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    • Montréal, Quebec, Canada, H3G1A4
      • Recruiting
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    • Montréal, Quebec, Canada, H2X 0C1
      • Recruiting
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    • Québec, Quebec, Canada, G1V 4G5
      • Recruiting
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    • Québec, Quebec, Canada, G1R 2J6
      • Recruiting
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    • Rimouski, Quebec, Canada, G5L5T1
      • Not yet recruiting
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    • Saint Charles Borromee, Quebec, Canada, J6E 6J2
      • Recruiting
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    • Saint-Jérôme, Quebec, Canada, J7Z 5T3
      • Recruiting
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    • St-Hubert, Quebec, Canada, J3Z 0C8
      • Recruiting
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    • Terrebonne, Quebec, Canada, J6V 2H2
      • Recruiting
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    • Trois-Rivières, Quebec, Canada, G8Z 3R9
      • Recruiting
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  • Quebec City
    • Greenfield Park, Quebec City, Canada, J4V 1L3
      • Not yet recruiting
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    • Sherbrooke, Quebec City, Canada, J1H5N4
      • Recruiting
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    • Valleyfield, Quebec City, Canada, J6T6C1
      • Not yet recruiting
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  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 0Q8
      • Not yet recruiting
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• Puerto Rico
  • Caguas, Puerto Rico, 00726
    • Not yet recruiting
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  • Carolina, Puerto Rico, 00984
    • Not yet recruiting
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• United States
  • Alabama
    • Alexander City, Alabama, United States, 35010
      • Recruiting
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    • Birmingham, Alabama, United States, 35211
      • Recruiting
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    • Fairhope, Alabama, United States, 36532
      • Recruiting
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    • Huntsville, Alabama, United States, 35801
      • Recruiting
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    • Mobile, Alabama, United States, 36608
      • Recruiting
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  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • Not yet recruiting
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    • Tucson, Arizona, United States, 85724
      • Not yet recruiting
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  • Arkansas
    • Jonesboro, Arkansas, United States, 72405
      • Not yet recruiting
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    • North Little Rock, Arkansas, United States, 72117
      • Recruiting
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  • California
    • Garden Grove, California, United States, 92844
      • Recruiting
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    • Huntington Beach, California, United States, 92648
      • Recruiting
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    • Long Beach, California, United States, 90813
      • Not yet recruiting
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    • Los Angeles, California, United States, 90025
      • Not yet recruiting
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    • Torrance, California, United States, 90502
      • Recruiting
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    • West Hills, California, United States, 91307
      • Recruiting
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  • Colorado
    • Golden, Colorado, United States, 80401
      • Recruiting
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    • Loveland, Colorado, United States, 80538
      • Not yet recruiting
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  • Florida
    • Boca Raton, Florida, United States, 33486
      • Recruiting
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    • Boca Raton, Florida, United States, 33434
      • Recruiting
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    • Clearwater, Florida, United States, 33756
      • Recruiting
      • Research Site
    • Doral, Florida, United States, 33166
      • Not yet recruiting
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    • Hialeah, Florida, United States, 33013
      • Not yet recruiting
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    • Homestead, Florida, United States, 33030
      • Recruiting
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    • Jacksonville, Florida, United States, 32209
      • Recruiting
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    • Kissimmee, Florida, United States, 32836
      • Recruiting
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    • Largo, Florida, United States, 33777
      • Recruiting
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    • Miami, Florida, United States, 33136
      • Recruiting
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    • Miami, Florida, United States, 33175
      • Not yet recruiting
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    • Miami, Florida, United States, 33032
      • Not yet recruiting
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    • Miami Lakes, Florida, United States, 33014
      • Recruiting
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    • North Miami Beach, Florida, United States, 33169
      • Not yet recruiting
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    • Ocala, Florida, United States, 34471
      • Not yet recruiting
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    • Pembroke Pines, Florida, United States, 33024
      • Recruiting
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    • Pensacola, Florida, United States, 32502
      • Not yet recruiting
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    • Port Charlotte, Florida, United States, 33952
      • Recruiting
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    • Safety Harbor, Florida, United States, 34695
      • Recruiting
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    • Tallahassee, Florida, United States, 32301
      • Not yet recruiting
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    • Winter Haven, Florida, United States, 33881
      • Not yet recruiting
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  • Georgia
    • Acworth, Georgia, United States, 30101
      • Recruiting
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  • Illinois
    • Chicago, Illinois, United States, 60616
      • Not yet recruiting
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    • Hazel Crest, Illinois, United States, 60429
      • Recruiting
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    • Park Ridge, Illinois, United States, 60068
      • Not yet recruiting
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  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Recruiting
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    • Newburgh, Indiana, United States, 47630
      • Recruiting
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    • Richmond, Indiana, United States, 37760
      • Not yet recruiting
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  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Not yet recruiting
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    • West Des Moines, Iowa, United States, 50266
      • Recruiting
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  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • Not yet recruiting
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    • Louisville, Kentucky, United States, 40202
      • Not yet recruiting
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  • Louisiana
    • Hammond, Louisiana, United States, 70403
      • Recruiting
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    • Mandeville, Louisiana, United States, 70448
      • Recruiting
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  • Maine
    • Bangor, Maine, United States, 04401
      • Recruiting
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  • Maryland
    • Baltimore, Maryland, United States, 21215
      • Not yet recruiting
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    • Bethesda, Maryland, United States, 20814
      • Not yet recruiting
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    • Bowie, Maryland, United States, 20715
      • Not yet recruiting
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    • Nottingham, Maryland, United States, 21236
      • Not yet recruiting
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  • Michigan
    • Dearborn, Michigan, United States, 48126
      • Recruiting
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    • Detroit, Michigan, United States, 48202
      • Not yet recruiting
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    • Midland, Michigan, United States, 48670
      • Recruiting
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    • Ypsilanti, Michigan, United States, 48197
      • Recruiting
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  • Minnesota
    • Coon Rapids, Minnesota, United States, 55433
      • Not yet recruiting
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    • Duluth, Minnesota, United States, 55805
      • Not yet recruiting
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    • Minneapolis, Minnesota, United States, 55407
      • Not yet recruiting
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    • Minneapolis, Minnesota, United States, 55417
      • Not yet recruiting
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    • Saint Cloud, Minnesota, United States, 56303
      • Recruiting
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  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Recruiting
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  • Nevada
    • Las Vegas, Nevada, United States, 89102
      • Not yet recruiting
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  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Recruiting
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    • Pomona, New Jersey, United States, 08240
      • Recruiting
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  • New York
    • Johnson City, New York, United States, 13790
      • Not yet recruiting
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  • North Carolina
    • Pinehurst, North Carolina, United States, 28374
      • Recruiting
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    • Rocky Mount, North Carolina, United States, 27804
      • Not yet recruiting
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    • Winston-Salem, North Carolina, United States, 27103
      • Not yet recruiting
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    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
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  • Ohio
    • Canton, Ohio, United States, 44710
      • Recruiting
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    • Cincinnati, Ohio, United States, 45201
      • Not yet recruiting
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    • Springfield, Ohio, United States, 45504
      • Recruiting
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    • Toledo, Ohio, United States, 43608
      • Not yet recruiting
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    • Zanesville, Ohio, United States, 43702
      • Not yet recruiting
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  • Pennsylvania
    • Chambersburg, Pennsylvania, United States, 17201
      • Not yet recruiting
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    • Hershey, Pennsylvania, United States, 17033
      • Not yet recruiting
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    • Wyomissing, Pennsylvania, United States, 19610
      • Not yet recruiting
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  • South Carolina
    • Rock Hill, South Carolina, United States, 29732
      • Not yet recruiting
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    • Spartanburg, South Carolina, United States, 29301
      • Not yet recruiting
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  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Recruiting
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  • Tennessee
    • Greeneville, Tennessee, United States, 37745
      • Recruiting
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    • Jefferson City, Tennessee, United States, 47374
      • Not yet recruiting
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    • Memphis, Tennessee, United States, 38120
      • Not yet recruiting
      • Research Site
    • Oak Ridge, Tennessee, United States, 37830
      • Recruiting
      • Research Site
    • Powell, Tennessee, United States, 37849
      • Recruiting
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  • Texas
    • Amarillo, Texas, United States, 79109
      • Recruiting
      • Research Site
    • Beaumont, Texas, United States, 77702
      • Recruiting
      • Research Site
    • Cypress, Texas, United States, 77429
      • Recruiting
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    • Dallas, Texas, United States, 75235
      • Recruiting
      • Research Site
    • Dallas, Texas, United States, 75216
      • Not yet recruiting
      • Research Site
    • Houston, Texas, United States, 77090
      • Recruiting
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    • Houston, Texas, United States, 77070
      • Recruiting
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    • Kingwood, Texas, United States, 77339
      • Recruiting
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    • McKinney, Texas, United States, 75071
      • Recruiting
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    • Port Arthur, Texas, United States, 77642
      • Recruiting
      • Research Site
    • Waco, Texas, United States, 76712
      • Not yet recruiting
      • Research Site
  • Virginia
    • Norfolk, Virginia, United States, 23510
      • Recruiting
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    • Richmond, Virginia, United States, 23219
      • Not yet recruiting
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects with the appropriate genetic background and recently hospitalized for ACS (up to 3 months following the index event), will be enrolled in this trial.
• Both male and female subjects age 45 years and over at screening visit (V1)
• AA genotype at variant gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS)
• Clinically stable, ie, free of ischemic symptoms at rest or with minimal exertion for at least 1 week prior to randomization
• Prior to randomization, subjects must have evidence of guidelines-based management of LDL-C, at a minimum to include medical and dietary treatment.
• Randomization within 3 months of the index ACS event

Exclusion Criteria:

• Females who are pregnant (negative urine pregnancy test required for all women of child-bearing potential at Visit 2, Day 0) or breast-feeding
• Women of childbearing potential (women who are not surgically sterile or postmenopausal defined as amenorrhea for >12 months) who are not using at least one highly effective method of contraception.
• New York Heart Association (NYHA) Class III or IV heart failure
• Index ACS event presumed due to uncontrolled hypertension
• Systolic blood pressure (BP) >180 mmHg and/or diastolic blood pressure >110 mmHg at the time of randomization despite anti-hypertensive therapy
• Subjects with clinically apparent liver disease, eg, jaundice, cholestasis, hepatic synthetic impairment, active hepatitis or last known ALT or AST level >3 x ULN within 6 months prior to randomization (excluding index event)
• History of persistent and unexplained creatine phosphokinase (CPK) levels > 5 times the ULN as assessed within 6 months prior to randomization (excluding index event)
• Last known eGFR < 30 mL/min/1.73m2 as assessed within 6 months prior to randomization
• History of malignancy or any other significant comorbidity, the prognosis or management of which is likely to interfere with study conduct or subjects with a life expectancy of less than 3 years.
• Presence of any last known laboratory value as evaluated prior to randomization that is considered by the investigator to potentially limit the patient's successful participation in the study
• Subjects who have received any investigational drug within 1 month of randomization, or who expect to participate in any other investigational drug or device study during the conduct of this trial
• Subjects who have undergone coronary artery bypass graft (CABG) surgery between the index event and randomization

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dalcetrapib; Dalcetrapib 600 mg (two 300 mg tablets) orally once daily	Drug: Dalcetrapib; Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets; Other Names: Cholesterol Ester Transfer Protein Inhibitor
Placebo Comparator: Placebo; Matching dalcetrapib placebo tablets (2 tablets) orally once per day	Drug: Placebo; matching placebo tablets; Other Names: Dalcetrapib matching placebo tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first occurrence of any fatal or non-fatal myocardial infarction (MI)	Time to patients experiencing major cardiovascular events	Average of 30 months from randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke	Time to patients experiencing major cardiovascular events	Average of 30 months from randomization
Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke	Time to patients experiencing first and recurrent occurrences	Average of 30 months from randomization
Fatal and non-fatal MI	Time to patients experiencing first and recurrent occurrences	Average of 30 months from randomization

Collaborators and Investigators

• Sponsor: DalCor Pharmaceuticals
• Collaborators: The Montreal Health Innovations Coordinating Center (MHICC)
• Investigators: Study Director: David Kallend, MBBS, DalCor

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027

Study Registration Dates

• First Submitted: June 15, 2023
• First Submitted That Met QC Criteria: June 15, 2023
• First Posted (Actual): June 26, 2023

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Disease; Syndrome; Acute Coronary Syndrome; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Dalcetrapib
• Other Study ID Numbers: DAL-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No