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)

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521912-21-00

Acronym

CDII235A12201

Enrollment

Registered

2026-01-13

Start date

2026-01-26

Completion date

Unknown

Last updated

2026-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular risk reduction in participants with elevated Lp(a)

Brief summary

Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 180, Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360

Detailed description

Time averaged percent change from baseline in Lp(a) measured (i) between Day 60 and Day 360; and (ii) between Day 240 and Day 360, Participant's status of achieving Lp(a) < 125 nmol/L at Day 180 and Day 360 (Yes, No), Participant's status of achieving Lp(a) < 75 nmol/L at Day 180 and Day 360, Incidence of Adverse events, safety laboratory parameters, and vital signs

Interventions

DRUGDII235

DRUGSODIUM CHLORIDE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 180, Time averaged percent change from baseline in Lp(a) measured between Day 60 and Day 360	—

Secondary

Measure	Time frame
Time averaged percent change from baseline in Lp(a) measured (i) between Day 60 and Day 360; and (ii) between Day 240 and Day 360, Participant's status of achieving Lp(a) < 125 nmol/L at Day 180 and Day 360 (Yes, No), Participant's status of achieving Lp(a) < 75 nmol/L at Day 180 and Day 360, Incidence of Adverse events, safety laboratory parameters, and vital signs	—

Countries

Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026