The dal-GenE trial

• Research type

  Research Study

• Full title

  A 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): The dal-GenE trial

• IRAS ID

  190690

• Contact name

  Patrick Schneider

• Contact email

  pschneider@dalcorpharma.com

• Sponsor organisation

  DalCor Pharma UK Ltd, Altrincham, Swiss Branch Zug

• Eudract number

  2015-003895-65

• Duration of Study in the UK

  4 years, 5 months, 1 days

• Research summary

  Summary of Research
  Coronary heart disease (CHD) occurs when the hearts blood supply is blocked by a build–up of fatty substances in the wall of coronary arteries.
  This can be caused by a variety of factors such as gender, age, smoking, and alteration in lipoprotein, molecules that carry cholesterol in the blood.

  Studies have shown that high levels of ‘bad cholesterol’ (LDL) in the blood is linked to CHD. Conversely high levels of ‘good cholesterol’ (HDL) can reduce the risk of heart disease and stroke.

  Cholesteryl ester transfer protein (CETP) is a protein that exchanges good cholesterol for bad cholesterol. Dalcor have developed a medicinal product called 'Dalcetrapib' that acts as an inhibitor to CETP (decreases its activity) and increases the levels of the good HDL cholesterol in the blood, which in turn can prevent heart disease.

  It has been thought that the effect of Dalcetrapib can vary according to a person’s genetic profile, and recent studies carried out have shown that patients with the AA genotype of the ADCY9 gene have a 39% risk in the reduction of death or further cardiac events.

  Dalcor pharmaceticals is sponsoring a study in patients who have been recently hospitalized for Acute Coronary Syndrome (e.g heart attack) and with the appropriate genetic profile to receive either:

  1) 600mg dalcetrapib once daily
  2) 600mg of placebo once daily

  This is a randomized, double-blind placebo controlled study in patients meaning that neither the patient nor the doctor will know what medication has been given. The study is placebo controlled which means that approximately half the patients will receive a drug with no medical effect.

  This is a multicentre study which will take place across Europe, USA , South America , it is anticipated that approximately 5000 patients will be recruited worldwide, approximately 350 from the UK.

  Summary of Results
  The study did not meet the pre-specified limit of acceptability. However, the study was impacted by the COVID-19 pandemic with results pre-pandemic demonstrating efficacy. The administration of dalcetrapib is safe and well-tolerated in patients with recent ACS.

  Dalcetrapib was well tolerated overall, and all side effects observed in patients on dalcetrapib occurred equally often in patients on placebo (dummy drug).

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  16/EM/0193

• Date of REC Opinion

  6 Jun 2016

• REC opinion

  Further Information Favourable Opinion