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Introduction to dal-GenE-2 (NCT05918861)

For Physicians

About dal-GenE-2

dal-GenE-2 is a clinical study, as listed on clinicaltrials.gov, to potentially confirm the effect of dalcetrapib (the study drug) on reducing the risk of having a major cardiovascular event (fatal and non-fatal heart attack) in a population with a specific gene variant (AA genotype at variant rs 1967309 in the ADCY9 gene). The dal-GenE-2 study is also known as the dal-302 clinical trial.

The official title of the study on clinicaltrials.gov is: Effect of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS) (dal-GenE-2)

Dalcetrapib is an investigational new drug (not approved yet by the regulatory health authorities) that has been previously tested in different large studies and demonstrated that it is well tolerated and has a potential benefit to reduce risk of major cardiovascular events (fatal and non-fatal heart attacks) in a population with a specific gene variant.

Study Information

  • Study Start: 2023-10
  • Study Type: Interventional Treatment
  • Study Phase: Phase 3
  • Number of participants: 2,000
  • Number of study sites: 150 across North America
  • Primary Completion (Estimated): 2027-08
  • Study Completion (Estimated): 2027-08
  • Gender: All genders
  • Ages: 45 years and over
  • Status: Recruiting

Detailed Eligibility Criteria For dal-GenE-2

For clinical trials, researchers identify patients who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments. Patients must meet all inclusion criteria and not have any of the exclusion criteria to be eligible for the study.

Those who are likely to qualify will undergo Genotype Assay Testing to evaluate genetic determination and 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 sites / locations

dal-GenE-2 will be conducted in 150 sites across North America

  • Subjects with the appropriate genetic background and recently hospitalized for Acute Coronary Syndrome (ACS) (up to 3 months following the index event), will be enrolled in this trial.

    Patients eligible for this study are defined with at least one of the following:

    • Spontaneous myocardial infarction (Type 1 or 2: non-atherosclerotic and non-embolic ACS events are not eligible)
    • Procedure related myocardial infarction (Type 4a)
    • Hospitalization for ACS (ECG abnormalities without biomarker elevations)
 
  • Both male and female subjects aged 45 years and over at screening visit.
  • AA genotype at variant rs 1967309 in the ADCY9 gene as determined by Genotype Assay Test, conducted at a designated investigational testing site (ITS).
  • Clinically stable, i.e., 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 cholesterol, at a minimum to include medical and dietary treatment.
  • Randomization within 3 months of the index ACS event.
  • 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

For more information on the study or to find a participating clinical trial centre:

For more information on the study or to become a clinical trial centre, please send an email to: 

DalGenE2.clinicaltrial@mhicc.org 

Please include your name, and clinical details (address, postal/zip code, and telephone).

dal-GenE-2 is a clinical study to confirm the effect of dalcetrapib (the study drug) on reducing the risk of having a major cardiovascular event (fatal and non-fatal heart attack) in a population with a specific gene variant (AA genotype at variant rs 1967309 in the ADCY9 gene).

Study sites / locations

dal-GenE-2 will be conducted in 150 sites across North America

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