A Study of DII235 in Adults With Elevated Lipoprotein(a)

Phase 2Active Not RecruitingNCT07235046

Novartis Pharmaceuticals234 enrolled

Overview

The main purpose of this study is to determine the safety and efficacy of DII235 in adults with elevated lipoprotein(a).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

234

Conditions

Lipoprotein Disorder

Interventions

DII235DRUG

Solution for injection

SalineDRUG

solution for injection

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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/exclusion criteria may apply

Locations (63)

Outcomes

Primary Outcomes

Time averaged percentage change from baseline between 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.

Time frame: baseline to 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

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.

Time frame: baseline to 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

Time frame: baseline to day 60 and day 360

Secondary Outcomes

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

Time frame: baseline to day 60 and 360

Difference between DII235 doses versus placebo in time-averaged percent change from baseline in Lp(a) measured between 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.

Data from ClinicalTrials.gov

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