CDII235A12201: DII235 in adults with elevated Lipoprotein(a)
Research type
Research Study
Full title
A multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study to evaluate efficacy, safety, and tolerability of DII235 in adults with elevated lipoprotein(a)
IRAS ID
1012000
Contact name
Fiona Morris
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Research summary
This clinical trial, sponsored by Novartis, is testing a new medicine called DII235 to see if it can safely lower high levels of a type of cholesterol called lipoprotein(a), or Lp(a), in adults who also have heart disease and/or diabetes. High Lp(a) can increase the risk of heart attacks and strokes. About 200 people aged 18 to 80 will take part. Participants will be randomly assigned to receive either DII235 or a placebo (a dummy treatment with no active medicine), and neither they nor the doctors will know which one they are getting. The main goals are to find out how much DII235 lowers Lp(a) compared to placebo, and to monitor for any side effects. The study will also check how many people reach safer cholesterol levels during the trial. Participants’ health will be closely watched before, during, and after treatment. The results will help researchers understand if DII235 could become a new treatment for people at risk of heart and blood vessel problems due to high Lp(a). After the trial, results will be shared in clear language with participants and the public.
REC name
North East - York Research Ethics Committee
REC reference
25/NE/0162
Date of REC Opinion
26 Nov 2025
REC opinion
Further Information Unfavourable Opinion