Lipoprotein Disorder
Conditions
Interventions
Placebo Comparator: Placebo Control (saline solution)
Experimental: DII235 solution for injection (Dose 1, Dose 2, Dose 3, Dose 4)
Sponsors
Maruyama Hideki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signed informed consent must be obtained prior to participation in the study. Male or female participants 18 to 80 years of age (inclusive) at the screening. Lp(a) >= 150 nmol/L at screening, measured at the central laboratory. Participants with evidence of atherosclerotic cardiovascular disease and/or type 2 diabetes mellitus.
Exclusion criteria
Exclusion criteria: Severe renal dysfunction. Hepatic dysfunction. Malignancy within the last 5 years. Use of investigational medications as defined in the protocol. History or presence at screening of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the Investigator, or sponsor if consulted, would potentially affect participant safety within the study or interfere with participating in or completing the study or with the interpretation of data.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time averaged percentage change from baseline between Day 60 and Day 180. Difference between DII235 dose 2 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360. Difference between DII235 dose 4 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360. | — |
Contacts
Public ContactHideki Maruyama
Novartis Pharma. K.K.
Outcome results
None listed