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A Research Study Looking at How NNC0385-0434 Tablets Work to Lower Blood Cholesterol in People With Heart Disease or a High Risk of Heart Disease

Phase 2

Waitlist Available

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to visit 10 (19 weeks + 4 days)

Summary

This trial tests a new pill called NNC0385-0434 to see if it can lower blood cholesterol levels. It targets people with high cholesterol who need better treatment options. The pill works by helping to reduce cholesterol in the blood, which can lower the risk of heart disease.

Eligible Conditions

Cardiovascular Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to visit 10 (19 weeks + 4 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to visit 10 (19 weeks + 4 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to visit 10 (19 weeks + 4 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in low-density lipoprotein (LDL)-cholesterol

Secondary study objectives

Change in high density lipoprotein (HDL)-cholesterol

Change in total Apo B

Change in total Apo CIII

+5 more

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Oral NNC0385-0434 40 mg ODExperimental Treatment1 Intervention

40 mg study drug co-formulated with 500 mg SNAC tablet once daily

Group II: Oral NNC0385-0434 15 mg once-daily (OD)Experimental Treatment1 Intervention

15 mg NNC0385-0434 co-formulated with 500 mg Salcaprozate sodium (SNAC) tablet once daily

Group III: Oral NNC0385-0434 100 mgExperimental Treatment1 Intervention

100 mg NNC0385-0434 co-formulated with 500 mg SNAC tablet once daily (51 participants)

Group IV: Subcutaneous evolocumab 140 mg Q2WActive Control1 Intervention

140 mg evolocumab Subcutaneous (s.c.) injections every 2 weeks (51 participants). The s.c. evolocumab arm is open-label to limit unnecessary injections

Group V: Oral placebo (NNC0385-0434 15 mg)Placebo Group1 Intervention

15 MG placebo administered as tablets (without SNAC) once daily

Group VI: Oral placebo (NNC0385-0434 40 mg)Placebo Group1 Intervention

placebo administered as tablets (without SNAC) once daily

Group VII: Oral placebo (NNC0385-0434 100 mg)Placebo Group1 Intervention

placebo administered as tablets (without SNAC) once daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NNC0385-0434 A 15 mg

2021