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 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
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Contact
Study Contact
- Name: Novo Nordisk
- Phone Number: (+1) 866-867-7178
- Email: clinicaltrials@novonordisk.com
Study Locations
-
-
California
-
Cypress, California, United States, 90630
- Altasciences Clinical LA, Inc.
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
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
Exclusion Criteria:
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%.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Quadruple
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Part A Single ascending dose (SAD) cohorts in healthy participants:
Healthy 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.
|
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.
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.
|
|
Experimental: Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants
Participants 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.
|
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.
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.
|
|
Experimental: Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:
Healthy 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.
|
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.
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.
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Part A (SAD): Number of treatment emergent adverse events (TEAEs)
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
|
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.
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From pre-dose (Day 1) to end of study (Day 110)
|
|
Part B (MAD): Number of treatment emergent adverse events (TEAEs)
Time Frame: From pre-dose (Day 1) to end of study (Day 131)
|
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.
|
From pre-dose (Day 1) to end of study (Day 131)
|
|
Part C (SAD): Number of treatment emergent adverse events (TEAEs)
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
|
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.
|
From pre-dose (Day 1) to end of study (Day 110)
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Part A (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
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Measured as hours*nanomoles per liter (h*nmol/L)
|
From pre-dose (Day 1) to end of study (Day 110)
|
|
Part A (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
|
Measured as nanomoles per liter (nmol/L)
|
From pre-dose (Day 1) to end of study (Day 110)
|
|
Part A (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
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Measured as hours (h)
|
From pre-dose (Day 1) to end of study (Day 110)
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|
Part A (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
|
Measured as hours
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From pre-dose (Day 1) to end of study (Day 110)
|
|
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
Time Frame: From pre-dose (Day 22) to 168 hours after last dose (Day 29)
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Measured as h*nmol/L
|
From pre-dose (Day 22) to 168 hours after last dose (Day 29)
|
|
Part B (MAD): Cmax, MD; the maximum serum concentration of NNC0491-6075 after last dose
Time Frame: From pre-dose (Day 22) to end of study (Day 131)
|
Measured as nmol/L
|
From pre-dose (Day 22) to end of study (Day 131)
|
|
Part B (MAD): t½, MD; the terminal half-life of NNC0491-6075 after last dose
Time Frame: From pre-dose (Day 22) to end of study (Day 131)
|
Measured as hours
|
From pre-dose (Day 22) to end of study (Day 131)
|
|
Part B (MAD): tmax, MD; The time to maximum concentration of NNC0491-6075 after last dose
Time Frame: From pre-dose (Day 22) to end of study (Day 131)
|
Measured as hours
|
From pre-dose (Day 22) to end of study (Day 131)
|
|
Part C (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
|
Measured as h*nmol/L
|
From pre-dose (Day 1) to end of study (Day 110)
|
|
Part C (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
|
Measured as nmol/L
|
From pre-dose (Day 1) to end of study (Day 110)
|
|
Part C (SAD): t½, SD; the terminal half-life of NNC0491-6075 after a single dose
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
|
Measured as hours
|
From pre-dose (Day 1) to end of study (Day 110)
|
|
Part C (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)
Time Frame: From pre-dose (Day 1) to end of study (Day 110)
|
Measured as hours
|
From pre-dose (Day 1) to end of study (Day 110)
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- NN6491-4973
- U1111-1285-1575 (Other Identifier: World Health Organization (WHO))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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