Clinical trial of enlicitide given with or without rosuvastatin in people with high cholesterol

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia

• IRAS ID

  1012843

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Clinicaltrials.gov Identifier

  NCT07216482

• Research summary

  Researchers are looking for new ways to lower the amount of low-density lipoprotein cholesterol (LDL-C). Lowering LDL-C can help lower a person’s chance of certain health problems, such as heart attack and stroke.

  Researchers designed a trial medicine called enlicitide to lower LDL-C. Researchers want to learn about giving enlicitide with another medicine called rosuvastatin. Rosuvastatin is a standard (usual) treatment to lower LDL-C.

  The trial goal is to learn if enlicitide given with rosuvastatin works better than placebo on lowering LDL-C in a person’s blood. A placebo looks like trial medicine but has no trial medicine in it.

  About 975 people aged 18-64 years old with high cholesterol can take part if they:
  • Have LDL-C of 100 milligrams per deciliter (mg/dL) or more on a blood test after fasting (not eating or drinking anything but water for at least 8 hours)
  • Have not taken or are not currently taking certain medicines for high cholesterol
  • Do not have certain types of heart disease or certain other health conditions
  • Are not of Asian descent

  Participants will receive 1 or 2 of these trial treatments:
  • Enlicitide by mouth, as tablets, once a day for 3 months
  • Rosuvastatin by mouth, as capsules, once a day for 3 months
  To make sure participants do not know which treatment or treatments they are receiving, some participants will also receive 1 or 2 placebos once a day for 3 months. Participants will take their trial treatment first thing in the morning on an empty stomach.

  People will be assigned by chance to receive one of the following:
  • Enlicitide and rosuvastatin (5/13 chance)
  • Rosuvastatin and placebo for enlicitide (5/13 chance)
  • Enlicitide and placebo for rosuvastatin (2/13 chance)
  • Placebo for enlicitide and placebo for rosuvastatin (1/13 chance)

  A participant may be in this trial for about 6 months.

• REC name

  London - Surrey Borders Research Ethics Committee

• REC reference

  25/LO/0655

• Date of REC Opinion

  28 Oct 2025

• REC opinion

  Further Information Favourable Opinion