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Healthy VolunteersPhase 1NCT05979428

A Study to Look at How Safe a New Medicine (NNC0491-6075) is in Healthy People and in Participants With High Levels of Fat in the Blood

A Phase 1 study testing NNC0491-6075 in people with Healthy Volunteers and Dyslipidaemia, run by Novo Nordisk A/S at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study is testing a new study medicine to treat people with high levels of fat in the blood. The main aim of the study is to see if the new study medicine is safe and how it works in the body. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Dyslipidaemia
What is being tested?
NNC0491-6075
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
106 participants
Where
1 siteUnited States
Study dates
7 Aug 2023to 14 Mar 2025
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 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Part A:
  • Men or women of non-childbearing potential
  • Aged 18-55 years (both inclusive) at the time of signing informed consent
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests (presence of dyslipidaemia [example hypertriglyceridemia] is allowed) performed during the screening visit, as judged by the investigator
  • Body mass index (BMI) between 18.5 and 34.9 kilograms per square meter (kg/m^2) (both inclusive) at screening
  • Non-Japanese defined as not meeting inclusion criteria for Part C
Show all 20Show fewer
  • Part B:
  • Men or women of non-childbearing potential
  • Aged 18-64 years (both inclusive) at the time of signing informed consent
  • Dyslipidaemia at screening defined as all the below: Fasting serum triglycerides (TGs) greater than or equal to 150 milligrams per deciliter (mg/dL) and less than or equal to 500 mg/dL. Participants must have two measurements performed for eligibility. Both measurements must be greater than or equal to 135 mg/dL and at least one must be greater than or equal to 150 mg/dL. One of the measurements may be based on medical records or pre-screening results if the test is no more than 90 days old. If TGs are measured twice during the screening period, the tests must be performed with at least 4 days apart. TGs measured in the screening period must be after a 10 hour fast
  • Fasting low-density lipoprotein cholesterol (LDL-C) greater than or equal to 50 mg/dL and less than 190 mg/dL
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator
  • BMI between 18.5 and 34.9 kg/m^2 (both inclusive) at screening
  • If on statin therapy the dose must have been stable for at least 8 weeks before screening and must be intended to remain stable throughout the study
  • Part C:
  • Men or women of non-childbearing potential
  • Aged 18-55 years (both inclusive) at the time of signing informed consent
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests (presence of dyslipidaemia [example, hypertriglyceridemia] is allowed) performed during the screening visit, as judged by the investigator
  • BMI between 18.5 and 34.9 kg/m^2 (both inclusive) at screening
  • Japanese defined as both biological parents of Japanese descent

Who cannot join

  • Part A,B and C:
  • Known or suspected hypersensitivity to study intervention(s) or related products
  • Any disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol
  • Use of prescription or non-prescription medicinal products within 14 days before screening. Exceptions are: Topical medications; occasional use of over-the-counter acetaminophen or Non-steroidal anti-inflammatory drugs (NSAIDs) at their labelled doses for mild pain; and statin therapy in Part B only if the dose has been stable for at least 8 weeks prior to screening and is intended to remain stable throughout the trial
  • Any laboratory safety parameters at screening outside the below laboratory ranges, see designated reference range documents for specific values: Alanine aminotransferase greater than upper limit of normal (ULN) +50 percentage (%), Aspartate aminotransferase greater than ULN +50%, Total Bilirubin greater than ULN +20%, Creatine kinase greater than ULN +50%.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Altasciences Clinical LA, Inc.

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Phase I, Randomised, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC0491-6075 Following Single Dose Administration to Healthy Participants and Multiple Doses to Participants With Dyslipidaemia

The study is testing a new study medicine to treat people with high levels of fat in the blood. The main aim of the study is to see if the new study medicine is safe and how it works in the body. Participants will either get NNC0491-6075 (the new study medicine) or placebo (a "dummy medicine" without active ingredients). Which treatment participants get is decided by chance. NNC0491-6075 is a new medicine which cannot be prescribed by doctors. The study has 3 parts (Part A, Part B and Part C). In Part A, investigators look at the effect of the study medicine after a single dose in healthy participants. Participants will get the study medicine either as injection(s) under the skin or as an infusion into a vein by the study staff. In Part B, investigators look at the effect of receiving the study medicine once weekly for four weeks in participants with high levels of fat in the blood but who are otherwise healthy. Participants will get the study medicine as injections under the skin by the study staff. In Part C, investigators look at the effect of the study medicine after a single dose in healthy participants of Japanese origin. Participants will get the study medicine either as injection(s) under the skin or as an infusion into a vein by the study staff. The study will last for about 18 months in total for Part A, Part B and Part C. Participants in Part A and Part C will be in the study for about 139 days each, from screening to the final visit while in Part B they will be in the study for about 160 days from screening to the final visit.

Being tested
NNC0491-6075, Placebo
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NNC0491-6075Drug

    NNC0491-6075 will be administered as a subcutaneous injection in a skinfold in the abdomen or intravenously into a vein in the wrist, elbow, or the back of the hand.

  • PlaceboDrug

    Placebo matched to NNC0491-6075 will be administered as a subcutaneous injection in a skinfold in the abdomen or intravenously into a vein in the wrist, elbow, or the back of the hand.

Study groups in NCT05979428
Study groupRoleWhat they receive
Part A Single ascending dose (SAD) cohorts in healthy participants:ExperimentalHealthy participants, randomized in 3:1 ratio in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 5 cohorts (Cohort A1, A2, A3, A4 and A5). In cohorts A1, A2 and A3, the participants will receive subcutaneous injection, whereas in cohorts A4 and A5 the administration will be performed intravenously.
Receives: Drug: NNC0491-6075; Drug: Placebo
Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participantsExperimentalParticipants with dyslipidemia, randomized in the ratio 2:1 in each of the cohorts will receive multiple ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort B1,B2 and B3). Participants will receive subcutaneous injections of either NNC0491-6075 or placebo once weekly for 4 weeks.
Receives: Drug: NNC0491-6075; Drug: Placebo
Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:ExperimentalHealthy Japanese participants, randomized in the ratio 3:1 in each of the cohorts will receive single ascending dose of either NNC0491-6075 or placebo in 3 cohorts (Cohort C1,C2 and C3). The route of administration will be subcutaneous or intravenous.
Receives: Drug: NNC0491-6075; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A (SAD): Number of treatment emergent adverse events (TEAEs)

    Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.

    Measured: From pre-dose (Day 1) to end of study (Day 110)

  2. Part B (MAD): Number of treatment emergent adverse events (TEAEs)

    Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.

    Measured: From pre-dose (Day 1) to end of study (Day 131)

  3. Part C (SAD): Number of treatment emergent adverse events (TEAEs)

    Measured as count of events. An adverse event (AE) is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. A TEAE is defined as an AE that either has onset time after first trial product administration and no later than the end of study visit or Is present before first trial product administration and increases in severity during the treatment period and no later than the end of study visit.

    Measured: From pre-dose (Day 1) to end of study (Day 110)

Secondary outcomes (12)

  1. Part A (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose

    Measured as hours*nanomoles per liter (h*nmol/L)

    Measured: From pre-dose (Day 1) to end of study (Day 110)

  2. Part A (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose

    Measured as nanomoles per liter (nmol/L)

    Measured: From pre-dose (Day 1) to end of study (Day 110)

  3. Part A (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose

    Measured as hours (h)

    Measured: From pre-dose (Day 1) to end of study (Day 110)

  4. Part A (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)

    Measured as hours

    Measured: From pre-dose (Day 1) to end of study (Day 110)

  5. Part B (MAD): AUC0-168h, MD; the area under the NNC0491-6075 serum concentration-time curve from time 0 to 168 hours after last dose

    Measured as h*nmol/L

    Measured: From pre-dose (Day 22) to 168 hours after last dose (Day 29)

  6. Part B (MAD): Cmax, MD; the maximum serum concentration of NNC0491-6075 after last dose

    Measured as nmol/L

    Measured: From pre-dose (Day 22) to end of study (Day 131)

  7. Part B (MAD): t½, MD; the terminal half-life of NNC0491-6075 after last dose

    Measured as hours

    Measured: From pre-dose (Day 22) to end of study (Day 131)

  8. Part B (MAD): tmax, MD; The time to maximum concentration of NNC0491-6075 after last dose

    Measured as hours

    Measured: From pre-dose (Day 22) to end of study (Day 131)

  9. Part C (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose

    Measured as h*nmol/L

    Measured: From pre-dose (Day 1) to end of study (Day 110)

  10. Part C (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose

    Measured as nmol/L

    Measured: From pre-dose (Day 1) to end of study (Day 110)

  11. Part C (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose

    Measured as hours

    Measured: From pre-dose (Day 1) to end of study (Day 110)

  12. Part C (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)

    Measured as hours

    Measured: From pre-dose (Day 1) to end of study (Day 110)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2023
  2. Study start7 Aug 2023
  3. Primary completion14 Mar 2025
  4. Study completion14 Mar 2025

Resources

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05979428
Sponsor's protocol ID
NN6491-4973
Other IDs
U1111-1285-1575
Status last verified
Aug 2026
First submitted
31 Jul 2023
Last updated
1 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NNC0491-6075 in people with Healthy Volunteers and Dyslipidaemia, run by Novo Nordisk A/S at 1 site in United States.

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 20 inclusion and 5 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 1 Sep 2026. 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 States. 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. 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?

Part A (SAD): Number of treatment emergent adverse events (TEAEs) (time frame: From pre-dose (Day 1) to end of study (Day 110)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05979428.

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 1 Sep 2026.

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