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A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels

Primary Purpose

Healthy Volunteers, Hypercholesterolaemia

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

NNC0385-0434

Placebo (NNC0385-0434)

About this trial

This is an interventional treatment trial for Healthy Volunteers

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy volunteers:

Body mass index between 20.0 kg/m^2 and 35.0 kg/m^2 (both inclusive).
Male subjects.
Aged 18-55 years (both inclusive) at the time of signing informed consent.

Patients with hypercholesterolaemia:

Body mass index between 20.0 kg/m^2 and 35.0 kg/m^2 (both inclusive).
Male subjects.
Aged 18-70 years (both inclusive) at the time of signing informed consent.
Stable treatment with high- or moderate-intensity statin defined as total daily dose level of rosuvastatin equal to or above 10 mg, atorvastatin equal to or above 10 mg, simvastatin equal to or above 20 mg, pravastatin equal to or above 40 mg, lovastatin equal to or above 40 mg, fluvastatin equal to or above 80 mg, or pitavastatin equal to or above 1 mg for at least 30 days prior to enrolment and expected to remain on this dose for the remainder of the trial.

Exclusion Criteria:

Healthy volunteers:

Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) and not using condom with spermicide combined with an effective method of contraception for their female partner(s) in the period from randomisation visit (V2) until 10 weeks following administration of the investigational medical product.
Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.

Patients with hypercholesterolaemia:

Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) and not using condom with spermicide combined with an effective method of contraception for their female partner(s) in the period from randomisation visit (V2) until 10 weeks following administration of the investigational medical product.
Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol.
Current treatment with ezetimibe unless treatment has been with a stable dose for at least 30 days prior to enrolment and expected to remain on this dose for the remainder of the study.
History (as declared by the subject or reported in the medical records) of heart failure or clinically significant cardiac arrhythmia.
History (as declared by the subject or reported in the medical records) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, peripheral vascular or cerebrovascular disease within 12 months prior to enrolment
Planned surgery or revascularization at time of screening.

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NNC0385-0434

Placebo (NNC0385-0434)

Arm Description

Healthy volunteers will be randomised to one of three cohorts. In each cohort of 8 participants, 6 will receive active drug and 2 will receive placebo. Following safety observation, patients with hypercholesterolaemia will enter a fourth cohort. There will be 15 participants in this cohort.

Healthy volunteers will be randomised to one of three cohorts. In each cohort of 8 participants, 6 will receive active drug and 2 will receive placebo.

Outcomes

Primary Outcome Measures

Number of treatment emergent adverse events (TEAEs)

Count

Secondary Outcome Measures

AUC0-∞,0434,SD; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to infinity after a single dose of s.c. NNC0385-0434

nmol/L*h

Cmax,0434,SD; the maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434

nmol/L

t½,0434,SD; the terminal half-life of NNC0385-0434 after a single dose of s.c. NNC0385-0434

tmax,0434,SD; the time to maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434

Change in fasting LDL-C levels after a single dose of s.c. NNC0385-0434

Ratio to pre-dose

Full Information

NCT ID

NCT04058834

First Posted

August 14, 2019

Last Updated

December 29, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT04058834

Brief Title

A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels

Official Title

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0385-0434 in Healthy Subjects and Patients With Hypercholesterolaemia

Study Type

Interventional

2. Study Status

Record Verification Date

December 2021

Overall Recruitment Status

Completed

Study Start Date

August 20, 2019 (Actual)

Primary Completion Date

April 23, 2020 (Actual)

Study Completion Date

April 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested) and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which one is decided by chance. The study medicine for each person is chosen by a computer. A dummy medicine (placebo) looks like the study medicine but has no effect on the body. The dummy medicine needs to be used in the study to find out if the study medicine works as expected. The dose of the study medicines that participants receive will depend on which group they get into. The study has 4 groups of 8-15 participants in each. Each group will get a different dose of NNC0385-0434 or placebo. Participants and the study doctor will not know which of the study medicine/dose participants will get. However, if a participant's safety is at risk, the study doctor will be told in order to decide the future treatment. NNC0385-0434 may help to clear cholesterol from the blood. When there is less cholesterol circulating in the blood over a long period of time, then there is less risk of arteries (blood vessels) being clogged or developing diseases of the heart and blood vessels. Each participant will get one injection under the skin and will be in the study for about 4 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Healthy Volunteers, Hypercholesterolaemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Four (4) cohorts are planned. In 3 cohorts, healthy subjects will be randomised in a 3:1 manner to receive either: 1) NNC0385-0434 or 2) Placebo (NNC0385-0434). Each cohort will last 10 weeks and there will be 3 weeks between cohorts. Following safety observation, a fourth cohort will be initiated with patients with hypercholesterolaemia. Patients will be randomised in a 2:1 manner to receive either: 1) NNC0385-0434 or 2) Placebo (NNC0385-0434).

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Sponsor staff involved in the clinical trial is masked according to company standard procedures

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NNC0385-0434

Arm Type

Experimental

Arm Description

Arm Title

Placebo (NNC0385-0434)

Arm Type

Placebo Comparator

Arm Description

Healthy volunteers will be randomised to one of three cohorts. In each cohort of 8 participants, 6 will receive active drug and 2 will receive placebo.

Intervention Type

Drug

Intervention Name(s)

NNC0385-0434

Intervention Description

Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)

Intervention Type

Drug

Intervention Name(s)

Placebo (NNC0385-0434)

Intervention Description

Healthy volunteers will receive one injection s.c.

Primary Outcome Measure Information:

Title

Number of treatment emergent adverse events (TEAEs)

Description

Count

Time Frame

From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)

Secondary Outcome Measure Information:

Title

AUC0-∞,0434,SD; the area under the NNC0385-0434 plasma concentration-time curve from time 0 to infinity after a single dose of s.c. NNC0385-0434

Description

nmol/L*h

Time Frame

From day of dose (Day 1) until end of treatment (Day 70)

Title

Cmax,0434,SD; the maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434

Description

nmol/L

Time Frame

From day of dose (Day 1) until end of treatment (Day 70)

Title

t½,0434,SD; the terminal half-life of NNC0385-0434 after a single dose of s.c. NNC0385-0434

Description

Time Frame

From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)

Title

tmax,0434,SD; the time to maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434

Description

Time Frame

From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)

Title

Change in fasting LDL-C levels after a single dose of s.c. NNC0385-0434

Description

Ratio to pre-dose

Time Frame

Day 1, day 70

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy volunteers: Body mass index between 20.0 kg/m^2 and 35.0 kg/m^2 (both inclusive). Male subjects. Aged 18-55 years (both inclusive) at the time of signing informed consent. Patients with hypercholesterolaemia: Body mass index between 20.0 kg/m^2 and 35.0 kg/m^2 (both inclusive). Male subjects. Aged 18-70 years (both inclusive) at the time of signing informed consent. Stable treatment with high- or moderate-intensity statin defined as total daily dose level of rosuvastatin equal to or above 10 mg, atorvastatin equal to or above 10 mg, simvastatin equal to or above 20 mg, pravastatin equal to or above 40 mg, lovastatin equal to or above 40 mg, fluvastatin equal to or above 80 mg, or pitavastatin equal to or above 1 mg for at least 30 days prior to enrolment and expected to remain on this dose for the remainder of the trial. Exclusion Criteria: Healthy volunteers: Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) and not using condom with spermicide combined with an effective method of contraception for their female partner(s) in the period from randomisation visit (V2) until 10 weeks following administration of the investigational medical product. Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. Patients with hypercholesterolaemia: Male subjects who are not surgically sterilised (vasectomy) and are sexually active with female partner(s) and not using condom with spermicide combined with an effective method of contraception for their female partner(s) in the period from randomisation visit (V2) until 10 weeks following administration of the investigational medical product. Any disorder which in the Investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. Current treatment with ezetimibe unless treatment has been with a stable dose for at least 30 days prior to enrolment and expected to remain on this dose for the remainder of the study. History (as declared by the subject or reported in the medical records) of heart failure or clinically significant cardiac arrhythmia. History (as declared by the subject or reported in the medical records) of myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, peripheral vascular or cerebrovascular disease within 12 months prior to enrolment Planned surgery or revascularization at time of screening.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Harrow

ZIP/Postal Code

HA1 3UJ

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Learn more about this trial

A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels

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