CompletedPhase 1

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

Denmark, Germany161 participantsStarted 2022-04-20

Plain-language 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.

Who can participate

Age range

18 Years – 64 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Single ascending dose (SAD) part: * Male aged 18-55 years (both inclusive) at screening * Body mass index between 18.5 kilogram per meter square (kg/m\^2) and 27.0 kg/m\^2 (both inclusive) at screening * Considered to be generally 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 * Multiple ascending dose (MAD) part (MAD QD and MAD QW): * Male aged 18-55 years (both inclusive) at screening * Body mass index between 25.0 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 * 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 * Type 2 diabetes (T2D) part: * Female of non-childbearing potential or male aged 18-64 years (both inclusive) at screening * Body mass index between 25.0 kg/m\^2 and 39.9 kg/m\^2 (both inclusive) at screening * Diagnosed with type 2 diabetes mellitus greater than or equal to (≥) 180 days before screening * Treatment naive to antidiabetic drugs or on a stable daily dose(s) of metformin therapy (any metformin formulation any dose) greater than or equal to (\>=) 60 days before screening * Insulin naive. However, short-term insulin t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part

Timeframe: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 22 days)

Number of treatment emergent adverse events (TEAE) in the Multiple ascending dose with daily dosing (MAD QD) subcutaneous cohort

Timeframe: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Number of treatment emergent adverse events (TEAE) in MAD QW s.c. cohort

Timeframe: From time of first dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Number of treatment emergent adverse events (TEAE) in T2D QW cohort

Timeframe: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)

Trial details

NCT IDNCT05363774

SponsorNovo Nordisk A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-04-02

View on ClinicalTrials.gov More Healthy Volunteers (Diabetes Mellitus, Type 2) trials