Healthy VolunteersPhase 1NCT04058834
A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels
A Phase 1 study testing NNC0385-0434 in people with Healthy Volunteers and Hypercholesterolaemia, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Hypercholesterolaemia
- What is being tested?
- NNC0385-0434
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Aug 2019to 23 Apr 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers, Hypercholesterolaemia
- Being tested
- NNC0385-0434, Placebo (NNC0385-0434)
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NNC0385-0434Drug
Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)
Placebo (NNC0385-0434)Drug
Healthy volunteers will receive one injection s.c.
| Study group | Role | What they receive |
|---|---|---|
| NNC0385-0434 | Experimental | 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. Receives: Drug: NNC0385-0434 |
| Placebo (NNC0385-0434) | Placebo comparator | 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. Receives: Drug: Placebo (NNC0385-0434) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAEs)
Count
Measured: From time of first dosing (Day 1) to completion of the post-treatment follow-up visit (Day 70)
Secondary outcomes (5)
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
Measured: From day of dose (Day 1) until end of treatment (Day 70)
Cmax,0434,SD; the maximum plasma concentration of NNC0385-0434 after a single dose of s.c. NNC0385-0434
nmol/L
Measured: From day of dose (Day 1) until end of treatment (Day 70)
t½,0434,SD; the terminal half-life of NNC0385-0434 after a single dose of s.c. NNC0385-0434
h
Measured: 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
h
Measured: 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
Ratio to pre-dose
Measured: Day 1, day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2019
- Study start20 Aug 2019
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04058834
- Sponsor's protocol ID
- NN6434-4493
- Other IDs
- U1111-1231-4690, 2019-001746-18, 2019
- Status last verified
- Dec 2021
- First submitted
- 14 Aug 2019
- Last updated
- 30 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04058834
- Acronym / sponsor ID
- NN6434-4493
- Conditions
- Healthy Volunteers, Hypercholesterolaemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 20 Aug 2019 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 16 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| NNC0385-0434 | Experimental | Drug: NNC0385-0434Healthy 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. |
| Placebo (NNC0385-0434) | Placebo comparator | Drug: 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
- Body mass index between 20.0 kg/m^2 and 35.0 kg/m^2 (both inclusive).
- Male subjects.
Key exclusion criteria (10 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NNC0385-0434Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin) | Drug | NNC0385-0434 |
| Placebo (NNC0385-0434)Healthy volunteers will receive one injection s.c. | Drug | Placebo (NNC0385-0434) |
Primary outcome
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
5 secondary outcomes
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)
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)
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)
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)
Change in fasting LDL-C levels after a single dose of s.c. NNC0385-0434
Time frame: Day 1, day 70
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2021.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor and Disclosure (1452) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NNC0385-0434 in people with Healthy Volunteers and Hypercholesterolaemia, run by Novo Nordisk A/S at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2021.