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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1252-3392 | Other Identifier | World Health Organization (WHO) | |
| 2020-002630-32 | EudraCT Number | ||
| 151409 | Other Identifier | IND Number |
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This study looks at how well a new medicine, NNC0385-0434, works to lower blood cholesterol levels. Participants will either get NNC0385-0434 as a tablet (a potential new medicine), or placebo as a tablet (a dummy medicine that looks like NNC0385-0434 but has no effect on the body), or evolocumab as an injection (a medicine that doctors can already prescribe).
Which treatment participants get is decided by chance. If participants get NNC0385-0434 or placebo participants will need to take 1 tablet every morning. If participants get evolocumab participants will need to take 1 injection every 2 weeks.
The study will last for about 22 weeks. About 255 people will participate in the study. Participants will have 9 visits to the clinic and 2 phone calls with the study doctor. Some people will be invited to participate in a sub-study and will have 4 extra visits (13 visits in total). Participants will have blood samples taken at all visits to the clinic (except visit 0). At 4 clinic visits, participants will have an electrocardiogram (ECG). This is a test to check your heart.
Women can only take part in the study if they are not able to become pregnant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral NNC0385-0434 15 mg once-daily (OD) | Experimental | 15 mg NNC0385-0434 co-formulated with 500 mg Salcaprozate sodium (SNAC) tablet once daily |
|
| Oral placebo (NNC0385-0434 15 mg) | Placebo Comparator | 15 MG placebo administered as tablets (without SNAC) once daily |
|
| Oral NNC0385-0434 40 mg OD | Experimental | 40 mg study drug co-formulated with 500 mg SNAC tablet once daily |
|
| Oral placebo (NNC0385-0434 40 mg) | Placebo Comparator | placebo administered as tablets (without SNAC) once daily |
|
| Oral NNC0385-0434 100 mg | Experimental | 100 mg NNC0385-0434 co-formulated with 500 mg SNAC tablet once daily (51 participants) |
|
| Oral placebo (NNC0385-0434 100 mg) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NNC0385-0434 A 15 mg | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol | Percentage change in LDL-cholesterol (LDL-C) (measured in milligrams per deciliter [mg/dL]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. The in-trial period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. | Baseline (week 0), week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Total Cholesterol | Percentage change in total cholesterol (measured in millimoles per iliter [mmol/L]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. |
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Inclusion Criteria:
Males or females of non-childbearing potential.
Established atherosclerotic cardiovascular disease (ASCVD) (criteria a) or ASCVD risk (criteria b):
Serum LDL-C above or equal to 1.8 mmol/L (above or equal to 70 mg/dL) as measured by the central laboratory at screening.
Japanese participants: Serum LDL-C above or equal to 2.6 mmol/L (above or equal to 100 mg/dL) for participants of 40 years of age or older and with a history of coronary heart disease, and serum LDL-C above or equal to 3.1 mmol/L (above or equal to 120 mg/dL) for all other Japanese participants
Participants must be on maximally tolerated dose of statins.
Participants not receiving statin must have documented evidence of intolerance to all doses of at least two different statins.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Transparency (dept. 1452) | Novo Nordisk A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Desert Oasis Hlthcr Med Group | Palm Springs | California | 92262 | United States | ||
| Excel Med Ctr Clinical Trials |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38310920 | Result | Koren MJ, Descamps O, Hata Y, Hengeveld EM, Hovingh GK, Ikonomidis I, Radu Juul Jensen MD, Langbakke IH, Martens FMAC, Sondergaard AL, Witkowski A, Koenig W. PCSK9 inhibition with orally administered NNC0385-0434 in hypercholesterolaemia: a randomised, double-blind, placebo-controlled and active-controlled phase 2 trial. Lancet Diabetes Endocrinol. 2024 Mar;12(3):174-183. doi: 10.1016/S2213-8587(23)00325-X. Epub 2024 Feb 1. |
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According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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The trial was conducted in 7 countries as follows (number of sites that screened participants/ number of sites that randomized participants): Belgium (5/5), Germany (4/4), Greece (6/6), Japan (4/4), Netherlands (6/6), Poland (5/5)and United States (12/12).
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| ID | Title | Description |
|---|---|---|
| FG000 | NNC0385-0434 15 mg | Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium [SNAC]) tablet orally once daily for 12 weeks. |
| FG001 | NNC0385-0434 40 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 21, 2021 | May 1, 2025 |
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The trial will be double-blinded within dose level of oral NNC0385-0434 and size-matched placebo arm. The subcutaneous (s.c.) evolocumab arm will be open label.
placebo administered as tablets (without SNAC) once daily |
|
| Subcutaneous evolocumab 140 mg Q2W | Active Comparator | 140 mg evolocumab Subcutaneous (s.c.) injections every 2 weeks (51 participants). The s.c. evolocumab arm is open-label to limit unnecessary injections |
|
|
| NNC0385-0434 A 40 mg | Drug | 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). |
|
| Placebo I A (for NNC0385-0434 A 15 mg) | Other | 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 |
|
| NNC0385-0434 A 100 mg | Drug | 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). |
|
| Placebo I A (for NNC0385-0434 A 40 mg) | Other | 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 |
|
| Placebo II A (for NNC0385-0434 A 100 mg) | Other | 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 |
|
| Evolocumab 140 mg/mL, Repatha® | Drug | 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 |
|
| Baseline (week 0), week 12 |
| Percentage Change in High Density Lipoprotein (HDL)-Cholesterol | Percentage change in HDL-cholesterol (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | Baseline (week 0), week 12 |
| Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol | Percentage change in VLDL-cholesterol (measured in mmol/L) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | Baseline (week 0), week 12 |
| Percentage Change in Triglycerides | Percentage change in triglycerides (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | Baseline (week 0), week 12 |
| Percentage Change in Total Apolipoprotein B (Apo B) | Percentage change in Apo B (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | Baseline (week 0), week 12 |
| Percentage Change in Total Apolipoprotein CIII (Apo CIII) | Percentage change in Apo CIII (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | Baseline (week 0), week 12 |
| Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline | Change in total Lp(a) (measured in mg/dL) at week 12 is presented as ratio to baseline. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | Baseline (week 0), week 12 |
| Number of Treatment-emergent Adverse Events (TEAEs) | An adverse events (AE) is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. All presented AEs are TEAEs. TEAEs was the number of AEs recorded during the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | From baseline (week 0) to 138 days |
| Boca Raton |
| Florida |
| 33434 |
| United States |
| Integrative Research Associates, Inc | Fort Lauderdale | Florida | 33312 | United States |
| Jacksonville Ctr For Clin Res | Jacksonville | Florida | 32216 | United States |
| Northwest Heart Clin. Res. | Arlington Heights | Illinois | 60005 | United States |
| Louisiana Heart Center | Covington | Louisiana | 70433 | United States |
| Louisiana Heart Center_Slidell | Slidell | Louisiana | 70458 | United States |
| VA NEB - Western IA Health Stm | Omaha | Nebraska | 68105 | United States |
| Univ of Nebraska Medical CTR | Omaha | Nebraska | 68198 | United States |
| Albany Medical College - Endo | Albany | New York | 12203 | United States |
| Southgate Medical Group, LLP | West Seneca | New York | 14224 | United States |
| Thyroid, Endocrinology, and Diabetes, PA | Dallas | Texas | 75208 | United States |
| PlanIt Research, PLLC | Houston | Texas | 77079 | United States |
| Algemeen Stedelijk Ziekenhuis - Aalst - Interventional Cardiology | Aalst | 9300 | Belgium |
| AZ Sint-Jan - Campus Brugge | Bruges | 8000 | Belgium |
| Ziekenhuis Oost-Limburg AV - Cardiology | Genk | 3600 | Belgium |
| Hôpital de Jolimont_Haine-Saint-Paul_0 | Haine-Saint-Paul | 7100 | Belgium |
| Jessa Ziekenhuis - Hasselt - Cardiology | Hasselt | 3500 | Belgium |
| MVZ CCB Frankfurt Und Main-Taunus GbR | Frankfurt | 60389 | Germany |
| Medical Center - University Of Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Deutsches Herzzentrum München - Klinik für Herz- und Kreislauferkrankungen | München | 80636 | Germany |
| Jacob, Villingen-Schwenningen | Villingen-Schwenningen | 78048 | Germany |
| "Sotiria" Thoracic Diseases Hospital of Athens | Athens | 11527 | Greece |
| Alexandra General Hospital, Therapeutic Clinic | Athens | 11528 | Greece |
| Konstantopouleio G.H. of Athens, "Agia Olga" | Athens | 14233 | Greece |
| "Hygeia" General Hospital of Athens | Athens | 15123 | Greece |
| U.G.H of Athens "Attikon" | Chaidari, Athens | 12462 | Greece |
| General Hospital of Chios "Skilitsio" | Chios | 82100 | Greece |
| Sanai Hospital | Saitama-shi, Saitama | 338-0837 | Japan |
| Shinden Higashi Clinic | Sendai-shi, Miyagi | 983-0039 | Japan |
| Soka Sugiura Internal Medicine Clinic | Soka-shi, Saitama | 340-0015 | Japan |
| Minamino Cardiovascular Hospital | Tokyo | 192-0918 | Japan |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Deventer Ziekenhuis | Deventer | 7416 SE | Netherlands |
| Martini Ziekenhuis | Groningen | 9728 NT | Netherlands |
| Spaarne Gasthuis | Haarlem | 2035 RC | Netherlands |
| Canisius-Wilhelmina Ziekenhuis | Nijmegen | 6532 SZ | Netherlands |
| D & A Research B.V. | Sneek | 8601 ZR | Netherlands |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-952 | Poland |
| Regionalny Osrodek Kardiologii | Lubin | 59-301 | Poland |
| Lubelskie Centrum Diagnostyczne Tomasz Blicharski | Świdnik | 21-040 | Poland |
| Uniwersyteckie Centrum Kliniczne WUM | Warsaw | 02-097 | Poland |
| Szpital Grochowski im. dr med. Rafała Masztaka Sp. z o.o. | Warsaw | 04-073 | Poland |
| Narodowy Instytut Kardiologii Stefana kardynała Wyszynskiego | Warsaw | 04-628 | Poland |
Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks.
| FG002 | NNC0385-0434 100 mg | Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks. |
| FG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| FG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
| Treated |
|
| Full Analysis Set |
|
| Safety Analysis Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Full analysis set (FAS) included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | NNC0385-0434 15 mg | Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium [SNAC]) tablet orally once daily for 12 weeks. |
| BG001 | NNC0385-0434 40 mg | Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks. |
| BG002 | NNC0385-0434 100 mg | Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks. |
| BG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| BG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Low-density Lipoprotein (LDL)-Cholesterol | Percentage change in LDL-cholesterol (LDL-C) (measured in milligrams per deciliter [mg/dL]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. The in-trial period is defined as the uninterrupted time interval from date of randomisation to date of last contact with trial site. | FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage change of LDL cholesterol | Baseline (week 0), week 12 |
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| Secondary | Percentage Change in Total Cholesterol | Percentage change in total cholesterol (measured in millimoles per iliter [mmol/L]) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage change of total cholesterol | Baseline (week 0), week 12 |
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| Secondary | Percentage Change in High Density Lipoprotein (HDL)-Cholesterol | Percentage change in HDL-cholesterol (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage change of HDL cholesterol | Baseline (week 0), week 12 |
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| Secondary | Percentage Change in Very Low Density Lipoprotein (VLDL)-Cholesterol | Percentage change in VLDL-cholesterol (measured in mmol/L) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage change of VLDL cholesterol | Baseline (week 0), week 12 |
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| Secondary | Percentage Change in Triglycerides | Percentage change in triglycerides (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage change of triglycerides | Baseline (week 0), week 12 |
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| Secondary | Percentage Change in Total Apolipoprotein B (Apo B) | Percentage change in Apo B (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage change of Apo B | Baseline (week 0), week 12 |
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| Secondary | Percentage Change in Total Apolipoprotein CIII (Apo CIII) | Percentage change in Apo CIII (measured in mg/dL) at week 12 is presented. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Mean | Standard Deviation | Percentage change of Apo CIII | Baseline (week 0), week 12 |
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| Secondary | Change in Total Lipoprotein(a) (Lp[a]): Ratio to Baseline | Change in total Lp(a) (measured in mg/dL) at week 12 is presented as ratio to baseline. Data is reported for the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | FAS included all randomized participants. Overall number of participants analyzed = participants with available data for this outcome measure. | Posted | Geometric Mean | Geometric Coefficient of Variation | Ratio of Lipoprotein (a) | Baseline (week 0), week 12 |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Treatment-emergent Adverse Events (TEAEs) | An adverse events (AE) is any untoward medical occurrence in a clinical trial participant that is temporally associated with the use of an investigational medicinal product (IMP), whether or not considered related to the IMP. All presented AEs are TEAEs. TEAEs was the number of AEs recorded during the on-treatment period. The on-treatment period is the time period where participants were considered exposed to trial product. The observation period starts at the date of first dose of trial product and ends at the first date of any of the following: The follow-up visit or the last date on randomised treatment regimen + 58 days or the end-date for the 'in-trial' observation period. | Safety analysis set (SAS) included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. | Posted | Number | Events | From baseline (week 0) to 138 days |
|
Up to 138 Days
All presented AEs are TEAEs. TEAEs: AEs recorded during on-treatment period. SAS included all participants randomly assigned to trial treatment who took at least 1 dose of trial product. On-treatment period: time period where participants were exposed to trial product. Observation period starts at date of first dose of trial product and ends at first date of any of following: follow-up visit or last date on randomised treatment regimen + 58 days or end-date for 'in-trial' observation period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NNC0385-0434 15 mg | Participants received 15 milligrams (mg) NNC0385-0434 (co-formulated with 500 mg salcaprozate sodium [SNAC]) tablet orally once daily for 12 weeks. | 0 | 53 | 1 | 53 | 16 | 53 |
| EG001 | NNC0385-0434 40 mg | Participants received 40 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks. | 0 | 53 | 3 | 53 | 14 | 53 |
| EG002 | NNC0385-0434 100 mg | Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks. | 0 | 53 | 1 | 53 | 19 | 53 |
| EG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. | 0 | 54 | 5 | 54 | 14 | 54 |
| EG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. | 0 | 54 | 3 | 54 | 17 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Biliary colic | Hepatobiliary disorders | MedDRA 25 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Coronary artery stenosis | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA 25 | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Loss of consciousness | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Myelopathy | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 25 | Systematic Assessment |
| |
| Oesophageal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 25 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Peripheral artery aneurysm | Vascular disorders | MedDRA 25 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Ventricular tachycardia | Cardiac disorders | MedDRA 25 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood creatine phosphokinase increased | Investigations | MedDRA 25 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 25 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 25 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 25 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25 | Systematic Assessment |
|
At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Reporting Office (2834) | Novo Nordisk A/S | (+1) 866-867-7178 | clinicaltrials@novonordisk.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 15, 2021 | May 1, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C577155 | evolocumab |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| White |
|
| Other |
|
LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate.
| ANCOVA |
| <.0001 |
| Treatment difference |
| -44.91 |
| 2-Sided |
| 95 |
| -56.04 |
| -33.79 |
| Superiority |
| LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate. | ANCOVA | <.0001 | Treatment difference | -61.83 | 2-Sided | 95 | -72.94 | -50.72 | Superiority |
| LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate. | Treatment difference | 33.32 | 2-Sided | 95 | 22.16 | 44.47 | Superiority |
| LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate. | Treatment difference | 20.35 | 2-Sided | 95 | 9.21 | 31.48 | Superiority |
| LDL-C percentage change at week 12 from baseline responses were analysed using an analysis of covariance model with randomised treatment and strata as factors and baseline LDL-C as covariate. | Treatment difference | 3.43 | 2-Sided | 95 | -7.81 | 14.68 | Superiority |
| OG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| OG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
|
|
| OG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| OG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
|
|
| OG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| OG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
|
|
| OG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| OG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
|
|
| OG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| OG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
|
|
| OG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| OG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
|
|
| OG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| OG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
|
|
Participants received 100 mg NNC0385-0434 (co-formulated with 500 mg SNAC) tablet orally once daily for 12 weeks. |
| OG003 | Placebo | Participants received placebo matched to NNC0385-0434 (without SNAC) tablet orally once daily for 12 weeks. |
| OG004 | Evolocumab 140 mg | Participants received 140 mg evolocumab subcutaneously (s.c.) every 2 weeks for 12 weeks. |
|
|