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

Phase 1

Recruiting

• Conditions: Obesity
• Interventions: Drug: NNC0519-0130

• Registration Number: NCT06718998
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-20
• Status Verified: 2024-12
• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Last Update Submitted: 2024-12-02
• Study First Posted: 2024-12-05
• Last Update Posted: 2024-12-05
• Primary Completion: 2025-04-07
• Study Completion: 2025-11-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1: NNC0519-0130	NNC0519-0130	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.
Arm 2: NNC0519-0130	NNC0519-0130	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.
Arm 3: NNC0519-0130	NNC0519-0130	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.
Arm 4: NNC0519-0130	NNC0519-0130	Participants will receive once-weekly s.c injections of NNC0519-0130 following a predetermined dose escalation regimen 4 in the main and extension phase.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events (AEs)	From randomisation (week 0) to week 18	Measured as number of events.

Trial Locations

Locations (1)

Clinical Trials Unit / Center for Medical Research; 🇦🇹 Graz, Austria