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A Research Study Investigating How NNC0385-0434 is Tolerated in People With or Without High Cholesterol Levels

NCT04058834 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2021-12-30

No results posted yet for this study

Summary

In this study, there are two study medicines: NNC0385-0434 (the new medicine being tested) and placebo (a 'dummy' medicine). Participants will only get one of these medicines - which one is decided by chance. The study medicine for each person is chosen by a computer. A dummy medicine (placebo) looks like the study medicine but has no effect on the body. The dummy medicine needs to be used in the study to find out if the study medicine works as expected. The dose of the study medicines that participants receive will depend on which group they get into. The study has 4 groups of 8-15 participants in each. Each group will get a different dose of NNC0385-0434 or placebo. Participants and the study doctor will not know which of the study medicine/dose participants will get. However, if a participant's safety is at risk, the study doctor will be told in order to decide the future treatment. NNC0385-0434 may help to clear cholesterol from the blood. When there is less cholesterol circulating in the blood over a long period of time, then there is less risk of arteries (blood vessels) being clogged or developing diseases of the heart and blood vessels. Each participant will get one injection under the skin and will be in the study for about 4 months.

Conditions

  • Healthy Volunteers
  • Hypercholesterolaemia

Interventions

DRUG

NNC0385-0434

Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)

DRUG

Placebo (NNC0385-0434)

Healthy volunteers will receive one injection s.c.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-20
Primary Completion
2020-04-23
Completion
2020-04-23

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04058834 on ClinicalTrials.gov