NCT05918861 · DalCor Pharmaceuticals
Effect of Dalcetrapib on CV Risk in a Genetically Defined Population With a Recent ACS
(dal-GenE-2)
What this study is about
This is a compared against an inactive treatment, randomly assigned, where neither patients nor doctors know which treatment is given, parallel group, phase 3 conducted at multiple hospitals 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.
View original scientific description
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.
Interventions
DRUG
Dalcetrapib
Cholesterol Ester Transfer Protein Inhibitor, 300 mg tablets
DRUG
Placebo
matching placebo tablets
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Alexander City, Alabama
- Birmingham, Alabama
- Fairhope, Alabama
- Huntsville, Alabama
- Mobile, Alabama
- Scottsdale, Arizona
- Tucson, Arizona
- Jonesboro, Arkansas
- North Little Rock, Arkansas
- Garden Grove, California
- Huntington Beach, California
- La Jolla, California
And 154 more locations — see the full list below.
Collaborators
The Montreal Health Innovations Coordinating Center (MHICC)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 22, 2026 · Source of record for eligibility and locations