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Oral NNC0385-0434 in Patients with ASCVD or ASCVD Risk
NCT04992065Phase 2
Key facts
- Status
- Completed
- Start
- Aug 2021
- Primary completion
- Apr 2022
- Countries
- 7
- Sponsor
- Novo Nordisk
- Modality
- Peptides, Small Molecules
- Drugs
- NNC0385-0434
- Conditions
- atherosclerotic cardiovascular disease (ASCVD)hypercholesterolemia
01
Overview
Phase 2, randomised, double-blind trial of NNC0385-0434 in atherosclerotic cardiovascular disease (ASCVD) and hypercholesterolemia (5 arms), sponsored by Novo Nordisk. Primary endpoint: Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol at 12 weeks. Started Aug 2021; status: completed.
02
Design
5 arms- Study design
- RandomizedDouble-blind
NNC0385-0434 15 mg
Oral NNC0385-0434 15 mg OD + SNAC
NNC0385-0434 40 mg
Oral NNC0385-0434 40 mg OD + SNAC
NNC0385-0434 100 mg
Oral NNC0385-0434 100 mg OD + SNAC
Placebo
Oral Placebo OD
Evolocumab
SC Evolocumab 140 mg Q2W
03
Who it enrols
Patients aged 40+ with established ASCVD or 50+ with ASCVD risk, on maximally tolerated statins with LDL-C >= 70 mg/dL (or higher for Japanese patients). Excludes recent MI/stroke, severe renal impairment, or recent PCSK9i use.
04
Endpoints
Primary
Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol
Secondary
Percentage Change in Total Cholesterol
Percentage Change in High Density Lipoprotein (HDL)-Cholesterol
Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol
Percentage Change in Triglycerides
Percentage Change in Total Apolipoprotein B
Percentage Change in Total Apolipoprotein CIII
Change in Total Lipoprotein(a) Ratio to Baseline
Number of Treatment-emergent Adverse Events
05
Results
Primary endpoints met
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