← Back to Search

Other

NNC0491-6075 for High Cholesterol

Phase 1
Recruiting
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part B: Men or women of non-childbearing potential aged 18-64 years at the time of signing informed consent, with dyslipidaemia at screening, considered generally healthy based on medical history, physical examination, and results of vital signs, electrocardiogram, and clinical laboratory tests, with BMI between 18.5 and 34.9 kg/m^2 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.
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from pre-dose (day 22) to 168 hours after last dose (day 29)
Awards & highlights

Study Summary

This trial tests a new medicine to treat high fat levels in the blood. Participants receive either the new medicine or placebo in three parts, lasting 18 months, to evaluate safety & effectiveness.

Who is the study for?
This trial is for healthy adults aged 18-55, or those with high fat levels in the blood aged 18-64. Participants must have a BMI of 18.5 to 34.9 kg/m^2 and stable health as confirmed by medical exams. Those on statins must be on a steady dose for at least 8 weeks prior.Check my eligibility
What is being tested?
The study tests NNC0491-6075's safety and how it works in the body compared to a placebo. It has three parts: single-dose effects in healthy people (Part A), weekly doses for four weeks in people with high fat levels (Part B), and single-dose effects in healthy Japanese participants (Part C).See study design
What are the potential side effects?
As this is an early-stage trial testing a new medication, potential side effects are not fully known but may include reactions at injection sites, general discomfort, or other unexpected symptoms related to the medicine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18-64, healthy with stable cholesterol treatment, and my BMI is between 18.5 and 34.9.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from pre-dose (day 22) to 168 hours after last dose (day 29)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from pre-dose (day 22) to 168 hours after last dose (day 29) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A (SAD): Number of treatment emergent adverse events (TEAEs)
Part B (MAD): Number of treatment emergent adverse events (TEAEs)
Part C (SAD): Number of treatment emergent adverse events (TEAEs)
Secondary outcome measures
Part A (SAD): AUC0-∞, SD; the area under the NNC0491-6075 serum concentration-time curve from 0 to infinity after a single dose
Part A (SAD): Cmax, SD; the maximum serum concentration of NNC0491-6075 after a single dose
Part A (SAD): tmax, SD; The time to maximum concentration of NNC0491-6075 after a single-dose (only from subcutaneous administration)
+9 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:Experimental Treatment2 Interventions
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.
Group II: Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participantsExperimental Treatment2 Interventions
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.
Group III: Part A Single ascending dose (SAD) cohorts in healthy participants:Experimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,514 Previous Clinical Trials
2,414,962 Total Patients Enrolled
Clinical Transparency dept. 2834Study DirectorNovo Nordisk A/S
36 Previous Clinical Trials
522,900 Total Patients Enrolled

Media Library

NNC0491-6075 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05979428 — Phase 1
Healthy Subjects Research Study Groups: Part A Single ascending dose (SAD) cohorts in healthy participants:, Part C: Single ascending dose (SAD) cohorts in healthy Japanese participants:, Part B Multiple ascending dose (MAD) cohorts in dyslipidemia participants
Healthy Subjects Clinical Trial 2023: NNC0491-6075 Highlights & Side Effects. Trial Name: NCT05979428 — Phase 1
NNC0491-6075 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05979428 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals being accepted as participants in this research project?

"According to the research protocol, only individuals between 18 and 55 years of age are eligible for enrollment."

Answered by AI

Has the FDA sanctioned Part A Single Ascending Dose (SAD) cohorts for healthy participants?

"There is minimal evidence regarding Part A Single ascending dose (SAD) cohorts safety, hence it was assigned a score of 1."

Answered by AI

How many individuals are participating in this medical experiment?

"Affirmative, clinicaltrials.gov displays evidence that this trial is currently seeking participants--it was posted on August 7th 2023 and the most recent update occurred a day later. To complete the study, 106 people need to be recruited from one medical centre."

Answered by AI

Is this medical trial currently taking on new participants?

"Affirmative. According to the information on clinicaltrials.gov, this medical trial is currently recruiting participants who meet its criteria of eligibility. The trial was initially broadcasted on August 7th 2023 and has since been modified as recently as 8/8/2023. Overall, 106 candidates are needed across a single location for full enrolment into the study's protocol."

Answered by AI

What are the ultimate goals of this experiment?

"The main endpoint of this study, which spans from the pre-dose phase (Day 1) to its conclusion (Day 110), involves assessing treatment emergent adverse events. Additionally, secondary objectives include measuring the maximum serum concentration of NNC0491-6075 in nanomoles per liter, determining the terminal half-life of the drug in hours and ascertaining the time it takes for a single dose administered subcutaneously to reach peak levels as measured by hours."

Answered by AI

Am I eligible to join this clinical study?

"The target cohort for this research are healthy individuals ranging in age between 18 and 55. A total of 106 participants need to be recruited."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
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
2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05979428.
~56 spots leftby Feb 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top