Can a new injection tame high blood fat?
NCT ID NCT05979428
First seen Sep 01, 2026 · Last updated Sep 02, 2026 · Updated 1 time
Summary
This trial tests an experimental medicine called NNC0491-6075 for people with high levels of fat in the blood. The main goal is to check whether the medicine is safe and how the body handles it. Healthy volunteers receive a single dose, while people with high blood fat receive weekly doses for four weeks. Some participants get a placebo, and the treatment is assigned by chance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- NNC0491-6075, an experimental medicine given as an injection under the skin or into a vein
- What this could lead to
- If it works, this could lead to a new treatment option for people with high levels of fat in the blood, potentially lowering their risk of heart problems.
- What could go wrong
- This is an early Phase 1 trial, so the main goal is safety, not proof of effectiveness. The medicine may not work as hoped, and side effects are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
106 people
The number who actually took part.
- Started
-
Aug 2023
- Finished
-
Mar 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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%.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Altasciences Clinical LA, Inc.
Cypress, California, 90630, United States
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