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Clinical Trials associated with Semaglutide (Novo Nordisk)/NNC0480-0389Investigation of the Safety and Efficacy of Semaglutide s.c. in Combination With NNC0480-0389 in Participants With Type 2 Diabetes - a Dose Finding Study
This study is looking at semaglutide in combination with a potential new medicine (NNC0480-0389) in people with type 2 diabetes.
The study is being conducted to see how well semaglutide, in combination with different doses of NNC0480-0389, work to lower blood sugar levels. Results from this study will be used to select the doses of the two medicines for other studies.
Participants will either get:
Semaglutide (a medicine doctors can already prescribe for treatment of type 2 diabetes) in combination with NNC0480-0389 (a potential new medicine) or placebo (a 'dummy' medicine that looks like the medicines but without any medicine).
NNC0480-0389 alone, or semaglutide alone which treatment participant get is decided by chance.
Participant will need to take 2-3 injections once every week during the study. One injection will be with semaglutide or placebo and 1-2 injections will be with NNC0480-0389 or placebo.
Participant must inject the study medicines themself into the stomach, thigh, or upper arm.
The study will last for about 41weeks. Participant will have 20 clinic visits. Participant will have blood samples taken at all clinic visits. At 3 clinic visits, participant will also have an electrocardiogram (ECG). This is a test to check participants heart. Participant will have their eyes checked before or at the start of the study and at the end of the study.
Women can only take part in the study if they are not able to become pregnant
A Study to Investigate the Pharmacokinetics of Semaglutide and NNC0480-0389 When Subcutaneously Administered as a Co-formulation or as Separate Injections in Healthy Participants
In this study, participants will receive semaglutide and NNC0480-0389 together at the same time. Semaglutide is a medicine that can already be prescribed, whereas NNC0480-0389 is a new potential medicine. Giving the medicines at the same time will be investigated once by using two separate syringes and once by using only one syringe containing both medicines ("co-formulation"). The co-formulation will be given together with an injection of placebo. Both medicines are tested for the treatment of type 2 diabetes. Giving the two complementary medicines at the same time is intended to lower blood sugar in people with type 2 diabetes. NNC0480-0389, in combination with semaglutide, is already being investigated in an ongoing human clinical study.
The aim of this study is to compare the amount of medicine (semaglutide and NNC0480-0389) in the blood: after participants received the medicines at the same time (0.5 mg semaglutide and 5 mg NNC0480-0389) using only one syringe (co-formulation)after participants received the medicines separately using two syringes.
For this purpose, the amount of semaglutide and NNC0480-0389 in the blood will be measured after participants received the medicines in co-formulation and after participants received the medicines using separate syringes. There will be two treatment periods: One period where participants receive the two medicines as two separate injections and another period where participants receive the two medicines in one injection (co-formulation), together with an injection of placebo. It will be randomly determined in which order participants will receive the 2 treatments (separate injections first or co-formulation first).
For both treatments the study medicines will be injected into a skin fold in the left and right stomach using a thin needle.Giving the medicines in the two treatment periods will take place at an interval of at least 8 weeks. The study can last for up to 19 weeks for each participant. This includes a screening period (up to 4 weeks), two treatment periods (5 weeks each) and a washout period (3 - 5 weeks). The washout period ensures that the given treatments and their effects have disappeared from the body. Participants will not receive any study medicines during this time. Participants will have 21 clinic visits. Some of the visits include overnight stays. Participants will have blood tests at every clinic visit.
For 4 visits (Visits 2, 11, 12 and 21; Day 1 and 36 of each period) participants must not have had any food or drink (water is allowed) for up to 8 hours before participantsr body weight is measured. Participants must be healthy and have a body mass index (BMI) between 20.0 and 29.9 kg/m2. If participants are a woman participants can only take part in this clinical study, if participants cannot get pregnant, for example, after menopause. A hormone test will be done to confirm this.
100 Clinical Results associated with Semaglutide (Novo Nordisk)/NNC0480-0389
100 Translational Medicine associated with Semaglutide (Novo Nordisk)/NNC0480-0389
100 Patents (Medical) associated with Semaglutide (Novo Nordisk)/NNC0480-0389
100 Deals associated with Semaglutide (Novo Nordisk)/NNC0480-0389