PROMINENT (K-877-302 - DIABETES STUDY)

• Research type

  Research Study

• Full title

  PROMINENT PEMAFIBRATE TO REDUCE CARDIOVASCULAR OUTCOMES BY REDUCING TRIGLYCERIDES IN PATIENTS WITH DIABETES

• IRAS ID

  220765

• Contact name

  Manish Saxena

• Contact email

  m.saxena@qmul.ac.uk

• Sponsor organisation

  Kowa Research Institute, Inc.

• Eudract number

  2016-003818-26

• Duration of Study in the UK

  9 years, 10 months, 1 days

• Research summary

  Around 10,000 participants in 750 study centres located in more than 20 countries around the world will take part in this study.

  The purpose of this study is to find out if K-877 (also called pemafibrate), the study drug, compared to placebo (a treatment which looks like the medicine but contains no active pemafibrate), lowers cardiovascular (CV) complications (also referred to as “events”), such as heart attack, stroke and death from these conditions, in adults with type-2 diabetes mellitus (T2D) who have elevated triglycerides (TGs; one type of fat), and low high-density lipoprotein cholesterol (HDL-C; “good” cholesterol). The study will also test whether the study drug has other possible benefits in patients with diabetes, and will test the safety of the study drug.

  Participants will continue taking the cholesterol lowering medication that they are currently receiving such as statins. Participants will be asked to take one tablet twice a day for the entire duration of the study (approximately 5 years).

  Participants will be assigned to receive either the study drug or placebo and will stay on this treatment until the end of the study. Participants will have an equal chance (1:1) of receiving one of the following:
  - Pemafibrate 0.2 mg twice a day
  - Placebo twice a day

  Taking part in this study will last approximately 5 years and it includes a Screening period, an evaluation/ treatment period and a follow-up period. During this time participants will be required to visit their clinical study centre several times or discuss their participation in the study by phone.

• REC name

  London - South East Research Ethics Committee

• REC reference

  17/LO/0236

• Date of REC Opinion

  23 Feb 2017

• REC opinion

  Favourable Opinion