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

Investigation of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Weekly Doses of NNC0519-0130 in Participants With Obesity and in Participants With Type 2 Diabetes With Either Overweight or Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: NNC0519-0130

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 1

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 14050
    • Parexel International GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NNC0519-0130; Participants will receive NNC0519-0130 once weekly (QW) subcutaneously(s.c.).	Drug: NNC0519-0130; NNC0519-0130 will be administered subcutaneously.
Placebo Comparator: Placebo; Participants will receive once weekly s.c. volume-matched placebo to NNC0519-0130.	Drug: Placebo; Placebo will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse events	Measured in number of events.	From time of first dosing (day 1) until completion of the end of study visit (day 274/253)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 12-lead electrocardiogram, Individual-specific heart rate corrected QT interval (QTcI)	Measured in milliseconds (ms).	From baseline (day - 1) until completion of the end of study visit (day 274/253)
Change in 12-lead electrocardiogram, Fridericia heart rate corrected QT interval (QTcF)	Measured in ms.	From baseline (day - 1) until completion of the end of study visit (day 274/253)
Area under the NNC0519-0130 plasma concentration-time curve in steady state	Measured in hours*nanomoles per liter (h*nmol/L).	From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
Maximum plasma concentration of NNC0519-0130 in steady state	Measured in nanomoles per liter (nmol/L).	From pre-dose until 7 days post-dose, for third and last doses in the maintenance period

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2024
• Primary Completion (Actual): December 10, 2025
• Study Completion (Actual): December 10, 2025

Study Registration Dates

• First Submitted: August 20, 2024
• First Submitted That Met QC Criteria: August 20, 2024
• First Posted (Actual): August 22, 2024

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NN9541-8116; U1111-1305-5164 (Other Identifier: Universal Trial Number); 2024-512719-28 (Other Identifier: EU CT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No