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A Research Study on the Effects of NNC0537-1482 in Healthy Individuals When Injected Under the Skin

NCT06625307 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2025-06-25

No results posted yet for this study

Summary

The study is testing a new medicine to potentially treat people with heart failure. The main purpose of the study is to see if the new study medicine is safe and how it works in the body. It is the first time NNC0537-1482 (the new study medicine) is tested in humans and will be tested in healthy individuals (men and postmenopausal women). Participant will either get NNC0537-1482 or placebo (a "dummy medicine" without any active ingredients). Which treatment the participant get is decided by chance and the participant will only get either the study medicine or placebo on one occasion. It will be injected under the skin of the stomach by the study staff and the number of injections will depend on the cohort participant is assigned to. NNC0537-1482 cannot be prescribed by doctors. The study consists of 6 cohorts (groups) with 6 different dosing levels. The study will last for about 9 months. Participation in the study will last up to 42 days (depending on the cohort participant are assigned to) with an additional screening period that can be up to 28 days. Participant will have up to 10 visits to the clinic during the study period. However, the total number of visits depend on which cohort participant is assigned to.

Conditions

Interventions

DRUG

NNC0537-1482

Administered via subcutaneous route

DRUG

Placebo

Administered via subcutaneous route

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency '(dept. 2834)' · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
22 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-10-03
Primary Completion
2025-05-04
Completion
2025-05-04

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases
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 NCT06625307 on ClinicalTrials.gov