Clinical trial comparing MK-0616 to other treatments in adults with high cholesterol

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of MK-0616 Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia

• IRAS ID

  1009598

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to lower the amount of bad cholesterol (also called low-density lipoprotein cholesterol or LDL-C). Lowering a person’s LDL-C can lower their chances of cardiovascular events such as heart attacks, stroke, and death.
  MK-0616, the trial medicine, is in a group of medicines called PCSK9i that have been shown to lower the amount of LDL-C in the blood. MK-0616 is unique that it is an oral PCSK9i compared to other PCSK9i that are all given as subcutaneous injections. As part of this trial, we want to compare MK-0616 to other approved therapies ezetimibe and bempedoic acid, which are medicines that lower cholesterol but in different ways than MK-0616.
  The goal of this trial is to learn if MK-0616 lowers the amount of LDL-C in a participant’s blood more than:
  • Ezetimibe alone
  • Bempedoic acid alone
  • Ezetimibe and bempedoic acid taken together
  About 300 participants with high cholesterol will be in this trial. They will be at least 18 years old and:
  • Have had, or have a high chance of having a heart attack, stroke, or other events due to plaque buildup in the blood vessels
  • Are currently taking a statin to treat high cholesterol
  • Do not have certain types of heart disease or other certain health conditions
  Participants will be assigned to one of these groups:
  • Group 1 will take MK-0616, placebo for ezetimibe, and placebo for bempedoic acid
  • Group 2 will take ezetimibe, placebo for MK-0616, and placebo for bempedoic acid
  • Group 3 will take bempedoic acid, placebo for MK-0616, and placebo for ezetimibe
  • Group 4 will take ezetimibe, bempedoic acid, and placebo for MK-0616
  Participants will take their treatment every day on an empty stomach and must not eat or drink anything, except small amounts of water, for 8 hours before and 30 minutes after taking the treatment.
  A participant may be in this trial for about 5 months.
  The trial is sponsored by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  24/LO/0401

• Date of REC Opinion

  24 Jul 2024

• REC opinion

  Further Information Favourable Opinion