NCT05363774

A Research Study of a New Medicine NNC0519-0130 in Healthy People, People With High Body Weight and People With Type 2 Diabetes.

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of NNC0519-0130 in Healthy Participants and Multiple Subcutaneous and Oral Doses of NNC0519-0130 in Participants With Overweight or Obesity and Participants With Type 2 Diabetes

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 161 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

NNC0519-0130 is a new medicine which may possibly help participants with type 2 diabetes, as it is expected to lower elevated sugar levels in the blood. The medicine may also lower the appetite. This could help reducing overweight which is often present in participants with type 2 diabetes. In this study NNC0519-0130 is given to humans for the first time. This study will be looking into how safe the new medicine NNC0519-0130 is and will measure its concentrations in the blood. Moreover, effects on blood sugar, blood fat and body weight will be tested. There are different study parts with different participants. Healthy participants (men), healthy participants (men) with high body weight and people with diabetes (men and women) take part. Single doses and multiple doses are tested and the medicine is studied as an injection or when given orally (as a tablet). The participants are invited to take part in a part of the study which will look at the effects of weekly injected doses of NNC0519-0130 taken over the course of several weeks. It is planned that participants will be given the study medicine once weekly. The dose will be increased every three weeks, if safety and tolerability allow. Participants will take up to six different dose levels. This means that the period with weekly injections of study medicine will in total last up to 18 weeks. Participants will either get the study medicine NNC0519-0130 or placebo (a 'dummy' medicine that looks like the medicines but without any active medicine). Which medicine participant gets is decided by chance. The injection of study medicine will be done by trained staff into the tissue underneath the skin of belly using a syringe and needle. The total duration of the study could last up to 25 weeks.

Conditions

• Healthy Volunteers (Diabetes Mellitus, Type 2)

Interventions

Type	Name	Description
DRUG	NNC0519-0130	SAD part: Participants will receive up to six dose levels of subcutaneous NNC0519-0130 in a sequential manner with the dose increasing between cohorts. MAD part: The participants in first cohort will receive NNC0519-0130 subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels. T2D part: Participants will receive NNC0519-0130 up to two dose levels with dose escalation within the cohort. MAD QW part: Participants will receive NNC0519-0130 up to 6 dose levels.
DRUG	Placebo (NNC0519-0130)	SAD part: Participants will receive up to six dose levels of subcutaneous placebo (NNC0519-0130) in a sequential manner with the dose increasing between cohorts. MAD part: Participants in first cohort will receive placebo (NNC0519-0130) subcutaneously up to 5 dose levels, and the participants in the second MAD cohort will receive NNC0519-0130 orally up to 4 dose levels. T2D part: Participants will receive placebo (NNC0519-0130) up to two dose levels with dose escalation within the cohort. MAD QW part: Participants will receive Placebo up to 6 dose levels.

Timeline

• Start date: 2022-04-20
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2022-05-06
• Last updated: 2025-12-31

Locations

3 sites across 2 countries: Denmark, Germany