A Research Study Comparing Different Ways of Increasing the Dose of NNC0519-0130 in Participants With Overweight or Obesity

NCT06718998 | Recruiting Phase 1

• 3 other identifiers: NN9541-7760U1111-1298-93402023-508940-23
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief Summary

Novo Nordisk is developing a new study medicine NNC0519-0130 to improve the treatment options for people living with type 2 diabetes and people with excess body weight. This study will look at the safety and tolerability of NNC0519-0130. The purpose of this study is to investigate if different ways of increasing the dose of NNC0519-0130 in the main and extension phase can lessen the side effects that may occur when people take NNC0519-0130. There will be four different ways of increasing the dose of the study medicine and participants will get assigned to one of these - which one the participants get is decided by chance. This study will last for about 24 weeks.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Number of Adverse Events (AEs)

  Measured as number of events.

  From randomisation (week 0) to week 18

Study Arms (4)

Arm 1: NNC0519-0130

EXPERIMENTAL

Participants will receive once-weekly subcutaneous (s.c) injections of NNC0519-0130 following a predetermined dose escalation regimen 1 in the main and extension phase.

Drug: NNC0519-0130

Arm 2: NNC0519-0130

EXPERIMENTAL

Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 2 in the main phase and extension phase.

Drug: NNC0519-0130

Arm 3: NNC0519-0130

EXPERIMENTAL

Participants will receive twice-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 3 in the main phase and extension phase.

Drug: NNC0519-0130

Arm 4: NNC0519-0130

EXPERIMENTAL

Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase.

Drug: NNC0519-0130

Interventions

NNC0519-0130 DRUG

Participants will receive once-weekly or twice weekly NNC0519-0130 subcutaneously.

Arm 1: NNC0519-0130; Arm 2: NNC0519-0130; Arm 3: NNC0519-0130; Arm 4: NNC0519-0130

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Female of non-childbearing potential, or male.
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 27.0 and 44.9 kilogram per square meter (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Considered to be otherwise healthy 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.

You may not qualify if:

• Any disorder, unwillingness or inability which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol.
• Glycated haemoglobin (HbA1c) greater than or equal to (\>=) 6.5 percentage (48 millimoles per mole \[mmol/mol\]) at screening.
• Use of prescription medicinal products or non-prescription drugs, except routine vitamins, occasional use of paracetamol, NSAIDs (nonsteroidal anti-inflammatory drugs), acetylsalicylic acid, or topical medication not reaching systemic circulation, within 14 days before screening.
• Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Medical University of Graz

Graz, 8010, Austria

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2024
• First Posted: December 5, 2024
• Study Start: November 20, 2024
• Primary Completion: January 8, 2026
• Study Completion: January 8, 2026
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)