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

PHASE2CompletedINTERVENTIONAL
Enrollment

267

Participants

Timeline

Start Date

August 3, 2021

Primary Completion Date

April 26, 2022

Study Completion Date

June 20, 2022

Conditions
Atherosclerotic Cardiovascular Disease
Interventions
DRUG

NNC0385-0434 A 15 mg

15 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).

DRUG

NNC0385-0434 A 40 mg

40 mg administered as one oral tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).

OTHER

Placebo I A (for NNC0385-0434 A 15 mg)

Placebo administered as 1 tablet once daily in the morning in a fasting state. The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day. The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces). placebo tablets are sized match to the active arm within dose level

DRUG

NNC0385-0434 A 100 mg

"100 mg administered as one oral tablet once daily in the morning in a fasting state.~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces)."

OTHER

Placebo I A (for NNC0385-0434 A 40 mg)

"Placebo administered as one tablet once daily in the morning in a fasting state.~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).~placebo tablets are sized match to the active arm within dose level"

OTHER

Placebo II A (for NNC0385-0434 A 100 mg)

"Placebo administered as one tablet once daily in the morning in a fasting state.~The tablet should be taken at least 30 min before the first food, beverage or other oral medications of the day.~The tablet can be taken with up to half a glass of water (approximately 120 mL/ 4 fluid ounces).~placebo tablets are sized match to the active arm within dose level"

DRUG

Evolocumab 140 mg/mL, Repatha®

"Every 2 weeks subcutaneous (s.c.) injection of 140 mg into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated. Administered using a pre-filled SureClick® autoinjector (single-use).~Dose volume: 1 mL"

Trial Locations (44)

3500

Jessa Ziekenhuis - Hasselt - Cardiology, Hasselt

3600

Ziekenhuis Oost-Limburg AV - Cardiology, Genk

7100

Hôpital de Jolimont_Haine-Saint-Paul_0, Haine-Saint-Paul

8000

AZ Sint-Jan - Campus Brugge, Bruges

9300

Algemeen Stedelijk Ziekenhuis - Aalst - Interventional Cardiology, Aalst

11527

"Sotiria Thoracic Diseases Hospital of Athens", Athens

11528

Alexandra General Hospital, Therapeutic Clinic, Athens

12203

Albany Medical College - Endo, Albany

12462

"U.G.H of Athens Attikon", Chaidari, Athens

14224

Southgate Medical Group, LLP, West Seneca

14233

"Konstantopouleio G.H. of Athens, Agia Olga", Athens

15123

"Hygeia General Hospital of Athens", Athens

32216

Jacksonville Ctr For Clin Res, Jacksonville

33312

Integrative Research Associates, Inc, Fort Lauderdale

33434

Excel Med Ctr Clinical Trials, Boca Raton

60005

Northwest Heart Clin. Res., Arlington Heights

60389

MVZ CCB Frankfurt Und Main-Taunus GbR, Frankfurt

68105

VA NEB - Western IA Health Stm, Omaha

68198

Univ of Nebraska Medical CTR, Omaha

70433

Louisiana Heart Center, Covington

70458

Louisiana Heart Center_Slidell, Slidell

75208

Thyroid, Endocrinology, and Diabetes, PA, Dallas

77079

PlanIt Research, PLLC, Houston

78048

Jacob, Villingen-Schwenningen, Villingen-Schwenningen

79106

Medical Center - University Of Freiburg, Freiburg im Breisgau

80636

Deutsches Herzzentrum München - Klinik für Herz- und Kreislauferkrankungen, München

82100

"General Hospital of Chios Skilitsio", Chios

92262

Desert Oasis Hlthcr Med Group, Palm Springs

338-0837

Sanai Hospital, Saitama-shi, Saitama

983-0039

Shinden Higashi Clinic, Sendai-shi, Miyagi

340-0015

Soka Sugiura Internal Medicine Clinic, Soka-shi, Saitama

192-0918

Minamino Cardiovascular Hospital, Tokyo

5223 GZ

Jeroen Bosch Ziekenhuis, 's-Hertogenbosch

7416 SE

Deventer Ziekenhuis, Deventer

9728 NT

Martini Ziekenhuis, Groningen

2035 RC

Spaarne Gasthuis, Haarlem

6532 SZ

Canisius-Wilhelmina Ziekenhuis, Nijmegen

8601 ZR

D & A Research B.V., Sneek

80-952

Uniwersyteckie Centrum Kliniczne, Gdansk

59-301

Regionalny Osrodek Kardiologii, Lubin

21-040

Lubelskie Centrum Diagnostyczne Tomasz Blicharski, Świdnik

02-097

Uniwersyteckie Centrum Kliniczne WUM, Warsaw

04-073

Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o., Warsaw

04-628

Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego, Warsaw

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY