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

Not Applicable

Not yet recruiting

• Conditions: Lipoprotein Disorder
• Interventions: Drug: Saline; Drug: DII235

• Registration Number: NCT07235046
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-14
• Study First Submitted QC: 2025-11-14
• Last Update Submitted: 2025-11-14
• Study First Posted: 2025-11-19
• Last Update Posted: 2025-11-19
• Study Start: 2025-12-29
• Primary Completion: 2027-09-08
• Study Completion: 2028-09-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Saline	Placebo
Arm 4	DII235	DII235 dose 3
Arm 2	DII235	DII235 dose 1
Arm 5	DII235	DII235 dose 4
Arm 3	DII235	DII235 dose 2

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.