Lipoprotein Disorder
Conditions
Keywords
Lipoprotein(a), cardiovascular disease, atherosclerotic cardiovascular disease (ASCVD), lipoprotein disorder, cardiovascular, cholesterol, hyperlipidemia, dyslipidemia, DII235
Brief summary
The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).
Interventions
DRUGDII235
Solution for injection
DRUGSaline
solution for injection
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
In order to preserve the integrity of the study and to minimize bias, a randomized double-blind study design is being used.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
* 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 Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time averaged percentage change from baseline between Day 60 and Day 180 | baseline to day 60 and day 180 | Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 180, defined as the area under the curve (AUC) between the Day 60 Visit date and the Day 180 Visit date, divided by the duration between the two visit dates. |
| Difference between DII235 dose 2 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360 | baseline to day 60 and day 360 | Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates. |
| Difference between DII235 dose 4 and placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360 | baseline to day 60 and day 360 | Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference between DII235 dose 1, dose 3 and placebo versus placebo in time-averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360 | baseline to day 60 and 360 | Time averaged change from baseline in log Lp(a) measured between Day 60 and Day 360, defined as the area under the curve (AUC) between the Day 60 visit date and the Day 360 visit date, divided by the duration between the two visit dates. |
| Difference between DII235 doses versus placebo in time-averaged percent change from baseline in Lp(a) measured between Day 240 and Day 360 | baseline to day 240 and Day 360 | Time averaged change from baseline in log Lp(a) measured between Day 240 and Day 360, defined as the area under the curve (AUC) between the Day 240 Visit date and the Day 360 Visit date, divided by the duration between the two visit dates. |
| Difference between DII235 doses versus placebo with respect to the proportion of participants in achieving Lp(a) < 125 nmol/L at Day 180 and Day 360 | Day 180 and Day 360 | Participant's status of achieving Lp(a) \< 125 nmol/L at Day 180 and at Day 360 (Yes, No), without having any defined intercurrent events. |
| Difference between DII235 doses versus placebo with respect to the proportion of participants in achieving Lp(a) < 75 nmol/L at Day 180 and Day 360 | Day 180 and Day 360 | Participant's status of achieving Lp(a) \< 75 nmol/L at Day 180 and at Day 360 (Yes, No), without having any defined intercurrent events. |
Countries
China, Germany, Japan, United States
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed