Ph 2b Study of MK-0616 in Hypercholesterolemia

• Research type

  Research Study

• Full title

  A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Hypercholesterolemia

• IRAS ID

  1004827

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc

• Eudract number

  2021-005221-24

• Clinicaltrials.gov Identifier

  NCT05261126

• Research summary

  Cardiovascular disease is the leading cause of global mortality and a major contributor to disability.
  Several therapies for hypercholesterolaemia (high cholesterol) that have received regulatory approval are injectable. MK-0616 is an orally administered therapy. An oral therapy can achieve equivalent low-density lipoprotein cholesterol (LDL-C) lowering as an injectable therapy. Additionally, it can offer potential advantages in simplicity of dosing, patient preference, and access.

  This trial is testing the safety and efficacy of MK-0616 compared to placebo in people with hypercholesterolaemia. MK-0616 has not been approved to treat people with high cholesterol.

  About 375 male and female participants, aged between 18 and 80 years old will be enrolled in this trial. Participants will be in the trial for approximately 21 weeks.

  There is a screening period to see if patients can join the trial lasting up to 21 days. Patients will visit the trial site one or more times during the screening period.

  After completing the screening period, eligible participants will be randomised in a 1:1:1:1:1 ratio to receive treatment in one of the following groups:
  • Group 1: MK-0616 (6 mg)
  • Group 2: MK-0616 (12 mg)
  • Group 3: MK-0616 (18 mg)
  • Group 4: MK-0616 (30 mg)
  • Group 5: Placebo
  Participants will take MK-0616 or placebo once daily by mouth on an empty stomach for 8 weeks, and will visit the trial site about 4 times. Patients will need to fast for at least 8 hours before each visit.
  During the study, participants will undergo procedures such as physical examinations, ECGs, and blood/urine sample collection.

  The participant will then enter an 8-week post-treatment follow-up period, and will visit the trial site about 2 times.

  The trial is sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (MSD).

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  22/LO/0110

• Date of REC Opinion

  16 Mar 2022

• REC opinion

  Further Information Favourable Opinion