Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Healthy Volunteers
Dyslipidaemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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. Part...
Eligibility Criteria
Inclusion
- 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
- 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%.
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 14 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT05979428
Start Date
August 7 2023
End Date
March 14 2025
Last Update
May 4 2025
Active Locations (1)
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1
Altasciences Clinical LA, Inc.
Cypress, California, United States, 90630