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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
161
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.
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.
Novo Nordisk Investigational Site
Søborg, Denmark
Profil GmbH & Co. KG
Mainz, Germany
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Number of treatment emergent adverse events (TEAE) in single ascending dose (SAD) part
Measured as Number of events
Time frame: 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
Measured as Number of events
Time frame: 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
Measured as Number of events
Time frame: 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
Measured as number of events
Time frame: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 133 days)
AUC0-∞,NNC0519-0130,SD: Area under the NNC0519-0130 plasma concentration-time curve from time 0 (time of dosing) to infinity after a single dose
Measured in h\*nmol/L
Time frame: From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)
Cmax,NNC0519-0130,SD: Maximum plasma concentration of NNC0519-0130 after a single dose
Measure in nmol/L
Time frame: From pre-dose (day 1) until completion of the follow-up visit (assessed up to 22 days)
Number of treatment emergent adverse events (TEAE) in the MAD QD oral cohort
Measured as Number of events
Time frame: From time of dosing (day 1) until completion of the follow-up visit (assessed up to 112 days)
AUC0-24h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in MAD QD part
Measured in h\*nmol/L
Time frame: From pre-dose (last dose in each treatment period) until 24 hours post-dose
Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in MAD QD part
Measured in nmol/L
Time frame: From pre-dose (last dose in each treatment period) until 24 hours postdose
AUC0-168h,NNC0519-0130,MD: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in T2D QW cohort
Measured in h\*nmol/L
Time frame: From pre-dose (last dose) until 168 hours post-dose
Cmax,NNC0519-0130,MD: Maximum plasma concentration of NNC0519-0130 after the last dose in T2D QW cohort
Measured in nmol/L
Time frame: From pre-dose (last dose) until 168 hours post-dose
AUC0-168h,NNC0519-0130,SS: Area under the NNC0519-0130 plasma concentration-time curve after the last dose in each treatment period in the MAD QW s.c. cohort
measured in h\*nmol/L
Time frame: From pre-dose (last dose in each treatment period) until 168 hours post-dose
Cmax,NNC0519-0130,SS: Maximum plasma concentration of NNC0519-0130 after the last dose in each treatment period in the MAD QW s.c. cohort
Measured in nmol/L
Time frame: From pre-dose (last dose in each treatment period) until 168 hours post-dose
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