Parexel International GmbH
Berlin, 14050, Germany
NCT Number: NCT06567041
A new study medicine called NNC0519-0130 to improve treatment options for people living with excess body weight, with or without type 2 diabetes. The purpose of the study is to investigate potential side effects and blood levels of NNC0519-0130, as well as changes in body weight, blood sugar levels, and heart activity. The study consists of two groups, with participants receiving either the study medicine (NNC0519-0130) or a placebo. Which treatment participants get is decided by chance and they can only participate in one group. Participants will be given the study medicine once weekly, and it should be taken on the same day each week. The treatment duration depends on the group participants are enrolled in, with the study lasting for 37 weeks for Group 1 and 34 weeks for Group 2.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Berlin, 14050, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants with obesity only:
Participants with type 2 diabetes with either overweight or obesity:
Exclusion criteria
Participants with obesity only:
Participants with type 2 diabetes with either overweight or obesity:
NNC0519-0130 will be administered subcutaneously.
Placebo will be administered subcutaneously.
Time frame: From time of first dosing (day 1) until completion of the end of study visit (day 274/253)
Measured in number of events.
Time frame: From baseline (day - 1) until completion of the end of study visit (day 274/253)
Measured in milliseconds (ms).
Time frame: From baseline (day - 1) until completion of the end of study visit (day 274/253)
Measured in ms.
Time frame: From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
Measured in hours*nanomoles per liter (h*nmol/L).
Time frame: From pre-dose until 7 days post-dose, for third and last doses in the maintenance period
Measured in nanomoles per liter (nmol/L).
Novo Nordisk A/S
Industry
Investigation of the Safety, Tolerability, Pharmacokinetics and Efficacy of Subcutaneous Weekly Doses of NNC0519-0130 in Participants With Obesity and in Participants With Type 2 Diabetes With Either Overweight or Obesity
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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