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A Research Study of How Safe a New Medicine Called NNC0519 0130 is and to Test Its Effect in People Living With Excess Body Weight With or Without Type 2 Diabetes

NCT06567041 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-12-31

No results posted yet for this study

Summary

A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart activity. The study consists of two groups, with participants receiving either the study medicine (NNC0519-0130) or a placebo. Which treatment participants get is decided by chance and they can only participate in one group. Participants will be given the study medicine once weekly, and it should be taken on the same day each week. The treatment duration depends on the group participants are enrolled in, with the study lasting for 37 weeks for Group 1 and 34 weeks for Group 2.

Conditions

  • Diabetes Mellitus, Type 2
  • Obesity

Interventions

DRUG

NNC0519-0130

NNC0519-0130 will be administered subcutaneously.

DRUG

Placebo

Placebo will be administered subcutaneously.

Sponsors & Collaborators

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2025-12-10
Completion
2025-12-10

Countries

  • Germany

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 NCT06567041 on ClinicalTrials.gov