A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels
NCT ID: NCT04058834
Last Updated: 2021-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
39 participants
INTERVENTIONAL
2019-08-20
2020-04-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
NNC0385-0434
Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)
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.
Placebo (NNC0385-0434)
Healthy volunteers will receive one injection s.c.
Interventions
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NNC0385-0434
Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)
Placebo (NNC0385-0434)
Healthy volunteers will receive one injection s.c.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
MALE
Yes
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Reporting Anchor and Disclosure (1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Harrow, , United Kingdom
Countries
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Other Identifiers
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U1111-1231-4690
Identifier Type: OTHER
Identifier Source: secondary_id
2019-001746-18
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN6434-4493
Identifier Type: -
Identifier Source: org_study_id