Recruiting
Phase 3

Dalcetrapib

Sponsor:

DalCor Pharmaceuticals

Code:

NCT05918861

Conditions

Acute Coronary Syndrome

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

Interventions

Dalcetrapib

Placebo

Study Details

Brief summary:

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.

Conditions

Acute Coronary Syndrome

Study ID

NCT05918861

Start date

Oct 3, 2023

Status verified date

Jun, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45+

Healthy Volunteers: Not accepted

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 Design

Enrollment

2000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dalcetrapib

Dalcetrapib 600 mg (two 300 mg tablets) orally once daily

placebo comparator: Placebo

Matching dalcetrapib placebo tablets (2 tablets) orally once per day

Interventions

Dalcetrapib

Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets

Placebo

matching placebo tablets

Primary outcome measure

  • Time to first occurrence of any fatal or non-fatal myocardial infarction (MI) [ Time Frame: Average of 30 months from randomization ]

Central Contacts and Locations

Central contacts

David Kallend, MBBS

+41 79 174 1830dkallend@dalcorpharma.com

Therese Heinonen, DVM

theinonen@dalcorpharma.com

Locations

Research Site

Recruiting

Birmingham, Alabama, United States, 35211

Research Site

Recruiting

Fairhope, Alabama, United States, 36532

Research Site

Recruiting

Huntsville, Alabama, United States, 35801

Research Site

Recruiting

Mobile, Alabama, United States, 36608

Research Site

Recruiting

Scottsdale, Arizona, United States, 85258

Research Site

Recruiting

Tucson, Arizona, United States, 85724

Research Site

Recruiting

North Little Rock, Arkansas, United States, 72117

Research Site

Recruiting

Huntington Beach, California, United States, 92648

Research Site

Recruiting

La Jolla, California, United States, 92037

Research Site

Recruiting

San Francisco, California, United States, 94143

Research Site

Recruiting

Santa Barbara, California, United States, 93105

Research Site

Recruiting

Stanford, California, United States, 94305

Research Site

Recruiting

Torrance, California, United States, 90502

Research Site

Recruiting

West Hills, California, United States, 91307

Research Site

Recruiting

Aurora, Colorado, United States, 80011

Research Site

Recruiting

Golden, Colorado, United States, 80401

Research Site

Recruiting

Hartford, Connecticut, United States, 06102

Research Site

Recruiting

New Haven, Connecticut, United States, 06519

Research Site

Recruiting

Newark, Delaware, United States, 19718

Research Site

Recruiting

Washington D.C., District of Columbia, United States, 20010

Research Site

Recruiting

Clearwater, Florida, United States, 33756

Research Site

Recruiting

Fort Lauderdale, Florida, United States, 33316

Research Site

Recruiting

Fort Myers, Florida, United States, 33908

Research Site

Recruiting

Homestead, Florida, United States, 33030

Research Site

Recruiting

Jacksonville, Florida, United States, 32209

Research Site

Recruiting

Largo, Florida, United States, 33777

Research Site

Recruiting

Miami, Florida, United States, 33032

Research Site

Recruiting

Miami, Florida, United States, 33136

Research Site

Recruiting

Miami, Florida, United States, 33145

Research Site

Recruiting

Miami Lakes, Florida, United States, 33014

Research Site

Recruiting

Miami Lakes, Florida, United States, 33016

Research Site

Recruiting

Ocala, Florida, United States, 34471

Research Site

Recruiting

Pembroke Pines, Florida, United States, 33024

Research Site

Recruiting

Port Charlotte, Florida, United States, 33952

Research Site

Recruiting

Safety Harbor, Florida, United States, 34695

Research Site

Recruiting

Sarasota, Florida, United States, 34239

Research Site

Recruiting

Tampa, Florida, United States, 33606

Research Site

Recruiting

Tampa, Florida, United States, 33607

Research Site

Recruiting

Winter Haven, Florida, United States, 33881

Research Site

Recruiting

Atlanta, Georgia, United States, 30310

Research Site

Recruiting

Atlanta, Georgia, United States, 30322

Research Site

Recruiting

Augusta, Georgia, United States, 30912

Research Site

Recruiting

McDonough, Georgia, United States, 30253

Research Site

Recruiting

Arlington Heights, Illinois, United States, 60005

Research Site

Recruiting

Chicago, Illinois, United States, 60616

Research Site

Recruiting

Glenview, Illinois, United States, 60026

Research Site

Recruiting

Springfield, Illinois, United States, 62702

Research Site

Recruiting

Indianapolis, Indiana, United States, 46202

Research Site

Recruiting

Munster, Indiana, United States, 46321

Research Site

Recruiting

Newburgh, Indiana, United States, 47630

Research Site

Recruiting

Richmond, Indiana, United States, 47374

Research Site

Recruiting

Davenport, Iowa, United States, 52801

Research Site

Recruiting

Iowa City, Iowa, United States, 52242

Research Site

Recruiting

Kansas City, Kansas, United States, 66160

Research Site

Recruiting

Lexington, Kentucky, United States, 40536

Research Site

Recruiting

Hammond, Louisiana, United States, 70403

Research Site

Recruiting

Lafayette, Louisiana, United States, 70503

Research Site

Recruiting

New Orleans, Louisiana, United States, 70121

Research Site

Recruiting

Bangor, Maine, United States, 04401

Research Site

Recruiting

Bethesda, Maryland, United States, 20814

Research Site

Recruiting

Bay City, Michigan, United States, 48708

Research Site

Recruiting

Dearborn, Michigan, United States, 48126

Research Site

Recruiting

Detroit, Michigan, United States, 48202

Research Site

Recruiting

Kalamazoo, Michigan, United States, 49048

Research Site

Recruiting

Midland, Michigan, United States, 48670

Research Site

Recruiting

Mount Clemens, Michigan, United States, 48043

Research Site

Recruiting

Petoskey, Michigan, United States, 49770

Research Site

Recruiting

Ypsilanti, Michigan, United States, 48197

Research Site

Recruiting

Minneapolis, Minnesota, United States, 55407

Research Site

Recruiting

Minneapolis, Minnesota, United States, 55417

Research Site

Recruiting

Saint Cloud, Minnesota, United States, 56303

Research Site

Recruiting

Tupelo, Mississippi, United States, 38801

Research Site

Recruiting

St Louis, Missouri, United States, 63110

Research Site

Recruiting

St Louis, Missouri, United States, 63136

Research Site

Recruiting

Omaha, Nebraska, United States, 68124

Research Site

Recruiting

Las Vegas, Nevada, United States, 89102

Research Site

Recruiting

Bridgewater, New Jersey, United States, 08807

Research Site

Recruiting

Hackensack, New Jersey, United States, 07601

Research Site

Recruiting

Pomona, New Jersey, United States, 08240

Research Site

Recruiting

Albuquerque, New Mexico, United States, 87102

Research Site

Recruiting

Albany, New York, United States, 12211

Research Site

Recruiting

Buffalo, New York, United States, 14203

Research Site

Recruiting

Johnson City, New York, United States, 13790

Research Site

Recruiting

New York, New York, United States, 10028

Research Site

Recruiting

Poughkeepsie, New York, United States, 12601

Research Site

Recruiting

Staten Island, New York, United States, 10310

Research Site

Recruiting

Stony Brook, New York, United States, 11794

Research Site

Recruiting

The Bronx, New York, United States, 10467

Research Site

Recruiting

Rocky Mount, North Carolina, United States, 27804

Research Site

Recruiting

Winston-Salem, North Carolina, United States, 27103

Research Site

Recruiting

Winston-Salem, North Carolina, United States, 27157

Research Site

Recruiting

Canton, Ohio, United States, 44710

Research Site

Recruiting

Cleveland, Ohio, United States, 44106

Research Site

Recruiting

Springfield, Ohio, United States, 45504

Research Site

Recruiting

Toledo, Ohio, United States, 43608

Research Site

Recruiting

Allentown, Pennsylvania, United States, 18103

Research Site

Recruiting

Chambersburg, Pennsylvania, United States, 17201

Research Site

Recruiting

Hershey, Pennsylvania, United States, 17033

Research Site

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Research Site

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Research Site

Recruiting

West Reading, Pennsylvania, United States, 19611

Research Site

Recruiting

Wyomissing, Pennsylvania, United States, 19610

Research Site

Recruiting

Providence, Rhode Island, United States, 02906

Research Site

Recruiting

Rock Hill, South Carolina, United States, 29732

Research Site

Recruiting

Spartanburg, South Carolina, United States, 29303

Research Site

Recruiting

Rapid City, South Dakota, United States, 57701

Research Site

Recruiting

Chattanooga, Tennessee, United States, 37403

Research Site

Recruiting

Greeneville, Tennessee, United States, 37745

Research Site

Recruiting

Jefferson City, Tennessee, United States, 37760

Research Site

Recruiting

Memphis, Tennessee, United States, 38120

Research Site

Recruiting

Oak Ridge, Tennessee, United States, 37830

Research Site

Recruiting

Powell, Tennessee, United States, 37849

Research Site

Recruiting

Amarillo, Texas, United States, 79106

Research Site

Recruiting

Cypress, Texas, United States, 77429

Research Site

Recruiting

Dallas, Texas, United States, 75216

Research Site

Recruiting

Dallas, Texas, United States, 75235

Research Site

Recruiting

Houston, Texas, United States, 77070

Research Site

Recruiting

Houston, Texas, United States, 77089

Research Site

Recruiting

Houston, Texas, United States, 77090

Research Site

Recruiting

Kingwood, Texas, United States, 77339

Research Site

Recruiting

McKinney, Texas, United States, 75071

Research Site

Recruiting

Victoria, Texas, United States, 77901

Research Site

Recruiting

Richmond, Virginia, United States, 23219

Research Site

Recruiting

Winchester, Virginia, United States, 22601

Research Site

Recruiting

Seattle, Washington, United States, 98122

Research Site

Recruiting

Edmonton, Alberta, Canada, T6G2B7

Research Site

Recruiting

Abbotsford British Columbia, British Columbia, Canada, V2S 0C2

Research Site

Recruiting

Burnaby, British Columbia, Canada, V5G 2X6

Research Site

Recruiting

Kamloops, British Columbia, Canada, V2C2T1

Research Site

Recruiting

Winnipeg, Manitoba, Canada, R2H 2A6

Research Site

Recruiting

Moncton, New Brunswick, Canada, E1C 2Z3

Research Site

Recruiting

Moncton, New Brunswick, Canada, E1G 1A7

Research Site

Recruiting

Halifax, Nova Scotia, Canada, B3H3A7

Research Site

Recruiting

Cambridge, Ontario, Canada, N1R 6V6

Research Site

Recruiting

Kingston, Ontario, Canada, K7L2V7

Research Site

Recruiting

London, Ontario, Canada, N6A 5A5

Research Site

Recruiting

Newmarket, Ontario, Canada, L3Y 2R2

Research Site

Recruiting

Scarborough Village, Ontario, Canada, M1B 4Z8

Research Site

Recruiting

Scarborough Village, Ontario, Canada, M1B 5N1

Research Site

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Research Site

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Research Site

Recruiting

Granby, Quebec, Canada, J2G 1T7

Research Site

Recruiting

Greenfield Park, Quebec, Canada, J4V 2H1

Research Site

Recruiting

Lévis, Quebec, Canada, G6V 9H4

Research Site

Recruiting

Montreal, Quebec, Canada, H1T1C8

Research Site

Recruiting

Montreal, Quebec, Canada, H2X 0C1

Research Site

Recruiting

Montreal, Quebec, Canada, H3G1A4

Research Site

Recruiting

Montreal, Quebec, Canada, H4J 1C5

Research Site

Recruiting

Québec, Quebec, Canada, G1R 2J6

Research Site

Recruiting

Québec, Quebec, Canada, G1V 4G5

Research Site

Recruiting

Rimouski, Quebec, Canada, G5L5T1

Research Site

Recruiting

Saint-Charles-Borromée, Quebec, Canada, J6E 6J2

Research Site

Recruiting

Saint-Hubert, Quebec, Canada, J3Z 0C8

Research Site

Recruiting

Saint-Jérôme, Quebec, Canada, J7Z 2V4

Research Site

Recruiting

Terrebonne, Quebec, Canada, J6V 2H2

Research Site

Recruiting

Trois-Rivières, Quebec, Canada, G8Z 3R9

Research Site

Recruiting

Sherbrooke, Quebec City, Canada, J1H5N4

More Information

Sponsor

DalCor Pharmaceuticals

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by DalCor Pharmaceuticals on 2026-06-22.