- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04058834
A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels
December 29, 2021 updated by: Novo Nordisk A/S
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0385-0434 in Healthy Subjects and Patients With Hypercholesterolaemia
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Harrow, United Kingdom, HA1 3UJ
- Novo Nordisk Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / 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.
|
Healthy volunteers and patients will receive one injection s.c.
(subcutaneously, under the skin)
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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.
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Healthy volunteers will receive one injection s.c.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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From day of dose (Day 1) until end of treatment (Day 70)
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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
|
From day of dose (Day 1) until end of treatment (Day 70)
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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
|
From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)
|
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
|
From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)
|
Change in fasting LDL-C levels after a single dose of s.c. NNC0385-0434
Time Frame: Day 1, day 70
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Ratio to pre-dose
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Day 1, day 70
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 20, 2019
Primary Completion (Actual)
April 23, 2020
Study Completion (Actual)
April 23, 2020
Study Registration Dates
First Submitted
August 14, 2019
First Submitted That Met QC Criteria
August 14, 2019
First Posted (Actual)
August 16, 2019
Study Record Updates
Last Update Posted (Actual)
December 30, 2021
Last Update Submitted That Met QC Criteria
December 29, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NN6434-4493
- U1111-1231-4690 (Other Identifier: World Health Organization (WHO))
- 2019-001746-18 (Registry Identifier: European Medicines Agency (EudraCT))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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