Acute Coronary SyndromePhase 3dal-GenE-2NCT05918861

Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS

A Phase 3 study testing Dalcetrapib in people with Acute Coronary Syndrome, run by DalCor Pharmaceuticals at 231 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 45 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: Dalcetrapib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 2,000 participants
Where: 231 sitesin 3 countries
Study dates: 3 Oct 2023to Aug 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

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 45 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

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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

Trial locations and contacts

231 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

David Kallend, MBBS contact

+41 79 174 1830

dkallend@dalcorpharma.com

Therese Heinonen, DVM contact

theinonen@dalcorpharma.com

Country

City, postcode or hospital

Sites recruiting now only

231 sites in 3 countries

United States186 sites, 148 recruiting

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Acworth, Georgia, 30101
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Albany, New York, 12211
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Albuquerque, New Mexico, 87102
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Alexander City, Alabama, 35010
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Allentown, Pennsylvania, 18013
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Allentown, Pennsylvania, 18103
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Amarillo, Texas, 79106
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Arlington Heights, Illinois, 60005
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Atlanta, Georgia, 30310
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Atlanta, Georgia, 30322
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Augusta, Georgia, 30912
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Aurora, Colorado, 80011
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Baltimore, Maryland, 21215
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Bangor, Maine, 04401
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Bartlesville, Oklahoma, 74006
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Bay City, Michigan, 48708
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Beaumont, Texas, 77702
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Bethesda, Maryland, 20814
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Birmingham, Alabama, 35211
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Bloomingdale, Illinois, 60108
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Boca Raton, Florida, 33434
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Boca Raton, Florida, 33486
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Bowie, Maryland, 20715
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Bridgewater, New Jersey, 08807
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Buffalo, New York, 14203
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Canton, Ohio, 44710
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Chambersburg, Pennsylvania, 17201
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Chattanooga, Tennessee, 37403
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Chicago, Illinois, 60612
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Chicago, Illinois, 60616
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Cincinnati, Ohio, 45219
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Cincinnati, Ohio, 45267
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Clearwater, Florida, 33756
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Cleveland, Ohio, 44106
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Columbia, Maryland, 21044
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Coon Rapids, Minnesota, 55433
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Corpus Christi, Texas, 78404
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Cypress, Texas, 77429
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Dallas, Texas, 75216
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Dallas, Texas, 75235
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Davenport, Iowa, 52801
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Dearborn, Michigan, 48126
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Detroit, Michigan, 48202
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Doral, Florida, 33166
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Duluth, Minnesota, 55805
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Edgewood, Kentucky, 41017
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Fairhope, Alabama, 36532
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Fort Lauderdale, Florida, 33316
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Fort Myers, Florida, 33908
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Fort Wayne, Indiana, 46845
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Fredericksburg, Virginia, 22401
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Gainesville, Florida, 32608
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Gainesville, Georgia, 30501
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Garden Grove, California, 92844
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Glenview, Illinois, 60026
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Golden, Colorado, 80401
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Greeneville, Tennessee, 37745
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Hackensack, New Jersey, 07601
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Hammond, Louisiana, 70403
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Hartford, Connecticut, 06102
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Hazel Crest, Illinois, 60429
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Hershey, Pennsylvania, 17033
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Hialeah, Florida, 33013
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Homestead, Florida, 33030
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Houston, Texas, 77070
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Houston, Texas, 77089
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Houston, Texas, 77090
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Huntington Beach, California, 92648
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Huntsville, Alabama, 35801
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Indianapolis, Indiana, 46202
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Iowa City, Iowa, 52242
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Jacksonville, Florida, 32209
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Jefferson City, Tennessee, 37760
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Johnson City, New York, 13790
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Jonesboro, Arkansas, 72405
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Kalamazoo, Michigan, 49048
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Kansas City, Kansas, 66160
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Kingwood, Texas, 77339
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Kissimmee, Florida, 34741
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La Jolla, California, 92037
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Lafayette, Louisiana, 70503
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Langhorne, Pennsylvania, 19047
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Lansing, Michigan, 48912
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Largo, Florida, 33777
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Las Vegas, Nevada, 89102
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Lexington, Kentucky, 40536
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Lincoln, Nebraska, 68506
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Long Beach, California, 90813
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Los Angeles, California, 90025
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Louisville, Kentucky, 40202
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Lutherville, Maryland, 21093
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Mandeville, Louisiana, 70448
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McDonough, Georgia, 30253
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McKinney, Texas, 75071
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Memphis, Tennessee, 38120
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Merrillville, Indiana, 46410
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Mesquite, Texas, 75149
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Miami, Florida, 33032
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Miami, Florida, 33033
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Miami, Florida, 33136
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Miami, Florida, 33145
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Miami, Florida, 33175
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Miami Lakes, Florida, 33014
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Miami Lakes, Florida, 33016
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Midland, Michigan, 48670
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Minneapolis, Minnesota, 55407
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Minneapolis, Minnesota, 55417
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Mobile, Alabama, 36608
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Mount Clemens, Michigan, 48043
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Munster, Indiana, 46321
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New Haven, Connecticut, 06519
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New Orleans, Louisiana, 70121
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New York, New York, 10028
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Newark, Delaware, 19718
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Newburgh, Indiana, 47630
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Newport Beach, California, 92648
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Newport Beach, California, 92658
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Newport News, Virginia, 23606
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Norfolk, Virginia, 23504
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North Little Rock, Arkansas, 72117
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Oak Ridge, Tennessee, 37830
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Ocala, Florida, 34471
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Oklahoma City, Oklahoma, 73112
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Omaha, Nebraska, 68124
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Orlando, Florida, 32803
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Park Ridge, Illinois, 60068
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Pembroke Pines, Florida, 33024
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Pensacola, Florida, 32502
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Petoskey, Michigan, 49770
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Philadelphia, Pennsylvania, 19104
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Philadelphia, Pennsylvania, 19107
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Philadelphia, Pennsylvania, 19152
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Pinehurst, North Carolina, 28374
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Pomona, New Jersey, 08240
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Port Arthur, Texas, 77642
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Port Charlotte, Florida, 33952
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Poughkeepsie, New York, 12601
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Powell, Tennessee, 37849
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Providence, Rhode Island, 02906
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Rapid City, South Dakota, 57701
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Richmond, Indiana, 47374
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Richmond, Virginia, 23219
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Rock Hill, South Carolina, 29732
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Rocky Mount, North Carolina, 27804
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Safety Harbor, Florida, 34695
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Saint Cloud, Minnesota, 56303
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San Antonio, Texas, 78207
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San Francisco, California, 94143
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Sanford, North Carolina, 27330
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Santa Barbara, California, 93105
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Sarasota, Florida, 34239
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Scottsdale, Arizona, 85258
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Seattle, Washington, 98122
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South Miami, Florida, 33143
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Spartanburg, South Carolina, 29303
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Springfield, Illinois, 62702
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Springfield, Missouri, 65804
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Springfield, Ohio, 45504
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St Louis, Missouri, 63110
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St Louis, Missouri, 63136
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Stanford, California, 94305
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Staten Island, New York, 10310
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Stony Brook, New York, 11794
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Tallahassee, Florida, 32308
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Tampa, Florida, 33606
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Tampa, Florida, 33607
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The Bronx, New York, 10467
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The Villages, Florida, 32162
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Toledo, Ohio, 43608
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Torrance, California, 90502
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Traverse City, Michigan, 49684
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Tucson, Arizona, 85724
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Tulsa, Oklahoma, 74104
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Tupelo, Mississippi, 38801
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Victoria, Texas, 77901
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Waco, Texas, 76712
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Washington D.C., District of Columbia, 20010
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West Des Moines, Iowa, 50266
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West Hills, California, 91307
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West Reading, Pennsylvania, 19611
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Winchester, Virginia, 22601
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Winston-Salem, North Carolina, 27103
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Winston-Salem, North Carolina, 27157
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Winter Haven, Florida, 33881
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Wyomissing, Pennsylvania, 19610
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Ypsilanti, Michigan, 48197
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Other trials in United States

Canada43 sites, 37 recruiting

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Abbotsford British Columbia, British Columbia, V2S 0C2
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Brampton, Ontario, L6R3J7
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Burnaby, British Columbia, V5G 2X6
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Calgary, Alberta, T1Y0B4
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Cambridge, Ontario, N1R 6V6
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Chicoutimi, Quebec, G7H 7K9
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Edmonton, Alberta, T6G2B7
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Granby, Quebec, J2G 1T7
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Greenfield Park, Quebec, J4V 2H1
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Halifax, Nova Scotia, B3H3A7
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Kamloops, British Columbia, V2C2T1
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Kingston, Ontario, K7L2V7
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Laval, Quebec, H7M 3L9
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Lévis, Quebec, G6V 9H4
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London, Ontario, N6A 5A5
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Moncton, New Brunswick, E1C 2Z3
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Moncton, New Brunswick, E1G 1A7
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Montreal, Quebec, H1T1C8
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Montreal, Quebec, H2X 0C1
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Montreal, Quebec, H3G1A4
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Montreal, Quebec, H4J 1C5
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Newmarket, Ontario, L3Y 2R2
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North Vancouver, British Columbia, V7M 2H4
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Ottawa, Ontario, K1Y4W7
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Québec, Quebec, G1R 2J6
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Québec, Quebec, G1V 4G5
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Rimouski, Quebec, G5L5T1
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Saint-Charles-Borromée, Quebec, J6E 6J2
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Saint-Hubert, Quebec, J3Z 0C8
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Saint-Jérôme, Quebec, J7Z 2V4
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Saskatoon, Saskatchewan, S7N 0W8
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Scarborough Village, Ontario, M1B 4Z8
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Scarborough Village, Ontario, M1B 5N1
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Sherbrooke, Quebec City, J1H5N4
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St. John's, Newfoundland and Labrador, A1B 3V6
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Terrebonne, Quebec, J6V 2H2
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Toronto, Ontario, M4N 3M5
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Toronto, Ontario, M5B 1W8
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Toronto, Ontario, M5G 2C4
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Trois-Rivières, Quebec, G8Z 3R9
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Vancouver, British Columbia, V5Z 1M9
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Victoria, British Columbia, V8R 1B2
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Winnipeg, Manitoba, R2H 2A6
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Other trials in Canada

Puerto Rico2 sites

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Caguas, Puerto Rico, 00726
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Carolina, 00984
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Other trials in Puerto Rico

About this study

Official title: 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.

Read the 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.

Conditions: Acute Coronary Syndrome
Being tested: Dalcetrapib, Placebo
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DalcetrapibDrug
Also called Cholesterol Ester Transfer Protein Inhibitor
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
PlaceboDrug
Also called Dalcetrapib matching placebo tablets
matching placebo tablets

Study groups in NCT05918861
Study group	Role	What they receive
Dalcetrapib	Experimental	Dalcetrapib 600 mg (two 300 mg tablets) orally once daily Receives: Drug: Dalcetrapib
Placebo	Placebo comparator	Matching dalcetrapib placebo tablets (2 tablets) orally once per day Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 2023Aug 2027

First posted26 Jun 2023
Study start3 Oct 2023
Primary completionAug 2027 (estimated)
Study completionAug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Placebo-controlled, randomized, double-blind, parallel group, multi-center
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 2,000 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05918861
Sponsor's protocol ID: DAL-302
Acronym: dal-GenE-2
Status last verified: Jun 2026
First submitted: 15 Jun 2023
Last updated: 22 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

David Kallend, MBBS

+41 79 174 1830

dkallend@dalcorpharma.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT05918861
Acronym / sponsor ID: dal-GenE-2 / DAL-302
Conditions: Acute Coronary Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 2,000 participants (estimated)
Lead sponsor: DalCor PharmaceuticalsIndustry (pharma, biotech, devices)
Collaborators: The Montreal Health Innovations Coordinating Center (MHICC)
Study start: 3 Oct 2023 (actual)
Primary completion: Aug 2027 (estimated)
Study completion: Aug 2027 (estimated)
First posted: 26 Jun 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Placebo-controlled, randomized, double-blind, parallel group, multi-center

Arm	Type	Receives
Dalcetrapib	Experimental	Drug: DalcetrapibDalcetrapib 600 mg (two 300 mg tablets) orally once daily
Placebo	Placebo comparator	Drug: PlaceboMatching dalcetrapib placebo tablets (2 tablets) orally once per day

Who may qualify

Ages: 45 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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

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
DalcetrapibAlso: Cholesterol Ester Transfer Protein InhibitorCholesterol Ester Transfer Protein Inhibitor, 300 mg tablets	Drug	Dalcetrapib
PlaceboAlso: Dalcetrapib matching placebo tabletsmatching placebo tablets	Drug	Placebo

Primary outcome

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

3 secondary outcomes

The composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Time frame: Average of 30 months from randomization
Composite of all-cause death, resuscitated cardiac arrest, non-fatal MI and non-fatal stroke
Time frame: Average of 30 months from randomization
Fatal and non-fatal MI
Time frame: Average of 30 months from randomization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
Individual participant dataSharing planned: No

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Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease

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.

David Kallend, MBBS contact

+41 79 174 1830

dkallend@dalcorpharma.com

Therese Heinonen, DVM contact

theinonen@dalcorpharma.com

David Kallend, MBBS study director

DalCor

231 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dalcetrapib in people with Acute Coronary Syndrome, run by DalCor Pharmaceuticals at 231 sites in 3 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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 231 sites in United States, Canada, Puerto Rico. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact David Kallend, MBBS (+41 79 174 1830, dkallend@dalcorpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first occurrence of any fatal or non-fatal myocardial infarction (MI) (time frame: Average of 30 months from randomization). 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 NCT05918861.

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 Jun 2026.