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NCT05979428 · ClinicalTrials.gov registry record · Phase 1
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, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 1
- Development phase
- 106
- Enrollment target
NCT05979428: Completed Phase 1 study, sponsored by Novo Nordisk A/S.
NCT05979428 is a Phase 1 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 106 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05979428, a Phase 1 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 106 participants
- Enrollment target
Study 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. 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.
Primary Outcome
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 treatmen
Interventions
- DRUG Placebo
- DRUG NNC0491-6075
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2023-08-07 |
| Est. Completion | 2025-03-14 |
| Phase | Phase 1 |
What the finished NCT05979428 record still lists
NCT05979428 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05979428 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05979428 about?
NCT05979428 is a clinical study titled "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". 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" withou...
What is the current status of trial NCT05979428?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 106 participants. The study started on 2023-08-07. Estimated completion is 2025-03-14.
What interventions are being tested in trial NCT05979428?
The interventions under investigation include: Placebo (DRUG), NNC0491-6075 (DRUG).
Who is sponsoring clinical trial NCT05979428?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05979428's enrollment target sits among peer trials
106 531st of 2000 higher than 1,468 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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