Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT07235046

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lipoprotein Disorder Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Luoyang, Henan, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DII235

Drug

Solution for injection

Saline

Drug

solution for injection

Primary outcomes

  1. Time averaged percentage change from baseline between Day 60 and Day 180

    Time frame: 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.

  2. 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 frame: 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.

  3. 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

    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 outcomes

  1. 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

    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.

  2. Difference between DII235 doses versus placebo in time-averaged percent change from baseline in Lp(a) measured between Day 240 and Day 360

    Time frame: 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.

  3. 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

    Time frame: 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.

  4. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Nov 19, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.