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NNC0385-0434 A 15 mg for Cardiovascular 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)
Awards & highlights

Study Summary

This study is evaluating whether a new medicine, NNC0385-0434, works to lower blood cholesterol levels.

Eligible Conditions
  • Cardiovascular Disease

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in low-density lipoprotein (LDL)-cholesterol
Secondary outcome measures
Change in high density lipoprotein (HDL)-cholesterol
Change in total Apo B
Change in total Apo CIII
+5 more

Side effects data

From 2020 Phase 4 trial • 259 Patients • NCT03096288
5%
chest pain
5%
gastrointestinal bleeding
100%
80%
60%
40%
20%
0%
Study treatment Arm
HPR - Evolocumab
HPR - Placebo
NPR - Evolocumab
NPR - Placebo

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 40 mg
2021
Completed Phase 2
~260
NNC0385-0434 A 100 mg
2021
Completed Phase 2
~260
NNC0385-0434 A 15 mg
2021
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,810 Total Patients Enrolled
Clinical Transparency (dept. 1452)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
44,865 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
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
2021. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04992065.
~70 spots leftby Apr 2025
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