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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

NCT ID: NCT06567041

Last Updated: 2025-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-07

Study Completion Date

2025-12-10

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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NNC0519-0130

Participants will receive NNC0519-0130 once weekly (QW) subcutaneously(s.c.).

Group Type EXPERIMENTAL

NNC0519-0130

Intervention Type DRUG

NNC0519-0130 will be administered subcutaneously.

Placebo

Participants will receive once weekly s.c. volume-matched placebo to NNC0519-0130.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be administered subcutaneously.

Interventions

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NNC0519-0130

NNC0519-0130 will be administered subcutaneously.

Intervention Type DRUG

Placebo

Placebo will be administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
* Male or female of non-childbearing potential.
* Age 18-55 years (both inclusive) at the time of signing the informed consent.
* Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Participants with obesity only:

* Body mass index between 30.0 kilogram per meter square (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.

Participants with type 2 diabetes with either overweight or obesity:

* Body mass index between 27.0 kg/m\^2 and 39.9kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
* Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening.
* Glycated haemoglobin (HbA1c) in the range of 6.5 percentage (%) (inclusive) and 9.5% (inclusive).

Exclusion Criteria

* Any condition, except T2D and hypertension, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological conditions (except diabetes mellitus and hypertension).
* Presence or history of cardiovascular disease including stable and unstable angina pectoris, myocardial infarction, transient ischaemic attack, stroke, cardiac decompensation, clinically significant arrhythmias or clinically significant conduction disorders.
* Participant is breastfeeding.

Participants with obesity only:

* HbA1c ≥ 6.5 % (48 millimoles per mol \[mmol/mol\]) at screening.

Participants with type 2 diabetes with either overweight or obesity:

* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Recurrent severe hypoglycaemia within the last year as judged by the investigator.
* Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Parexel International GmbH

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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U1111-1305-5164

Identifier Type: OTHER

Identifier Source: secondary_id

2024-512719-28

Identifier Type: OTHER

Identifier Source: secondary_id

NN9541-8116

Identifier Type: -

Identifier Source: org_study_id