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

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ClinicalTrials.gov Identifier: NCT04058834
Recruitment Status : Recruiting
First Posted : August 16, 2019
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Hypercholesterolaemia Drug: NNC0385-0434 Drug: Placebo (NNC0385-0434) Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
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
Actual Study Start Date : August 20, 2019
Estimated Primary Completion Date : February 3, 2020
Estimated Study Completion Date : February 3, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NNC0385-0434
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.
Drug: NNC0385-0434
Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)

Placebo Comparator: Placebo (NNC0385-0434)
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.
Drug: Placebo (NNC0385-0434)
Healthy volunteers will receive one injection s.c.




Primary Outcome Measures :
  1. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70) ]
    Count


Secondary Outcome Measures :
  1. 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 [ Time Frame: From day of dose (Day 1) until end of treatment (Day 70) ]
    nmol/L*h

  2. Cmax,0434,SD; the maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434 [ Time Frame: From day of dose (Day 1) until end of treatment (Day 70) ]
    nmol/L

  3. t½,0434,SD; the terminal half-life of NNC0385-0434 after a single dose of s.c. NNC0385-0434 [ Time Frame: From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70) ]
    h

  4. tmax,0434,SD; the time to maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434 [ Time Frame: From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70) ]
    h

  5. Change in fasting LDL-C levels after a single dose of s.c. NNC0385-0434 [ Time Frame: Day 1, day 70 ]
    Ratio to pre-dose



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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 of high-intensity statin defined as fixed dose level of rosuvastatin equal to or above 20 mg/day, or atorvastatin equal to or above 40 mg/day for at least 30 days prior to enrolment and expected to remain on this dose for the remainder of the study.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04058834


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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United Kingdom
Novo Nordisk Investigational Site Recruiting
Harrow, United Kingdom, HA1 3UJ
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04058834     History of Changes
Other Study ID Numbers: NN6434-4493
U1111-1231-4690 ( Other Identifier: World Health Organization (WHO) )
2019-001746-18 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: August 16, 2019    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases