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

Novartis

Status and phase: Enrolling; Phase 2

Conditions: Lipoprotein Disorder

Treatments: Drug: Saline; Drug: DII235

Study type: Interventional

Funder types: Industry

Identifiers

NCT07235046

CDII235A12201

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 5 patient groups, including a placebo group

Arm 1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Saline

Arm 2

Experimental group

Description:

DII235 dose 1

Treatment:

Drug: DII235

Arm 3

Experimental group

Description:

DII235 dose 2

Treatment:

Drug: DII235

Arm 4

Experimental group

Description:

DII235 dose 3

Treatment:

Drug: DII235

Arm 5

Experimental group

Description:

DII235 dose 4

Treatment:

Drug: DII235