NCT04259801

First Research Study to Look at How Two Medicines, NNC0480-0389 and Semaglutide, Work Together in Healthy People, in People With High Body Weight and in People With Diabetes

Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of NNC0480-0389 in Combination With Semaglutide s.c.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to investigate how safe, and how well tolerated, the new study drug NNC0480-0389 is when it is given together with semaglutide. This will be investigated in healthy participants, participants with high bodyweight and participants with type 2 diabetes (T2D). NNC0480-0389 has not been given to humans before. It has been previously tested in the laboratory and on animals. NNC0480-0389 will be tested at various dose levels. Semaglutide is a new approved drug and is already available on the market for treatment of diabetes. It will also be investigated how quickly and to what extent NNC0480-0389 and semaglutide are taken up and eliminated from the body. This is called pharmacokinetics. The effect of NNC0480-0389 given together with semaglutide will also be investigated on body weight and glucose levels in the blood. This is called pharmacodynamics. The effects of NNC0480-0389 and/or semaglutide will be compared to the effects of a placebo. A placebo is a "dummy" medicine without any active medicine. Placebo looks like NNC0480-0389 and/or semaglutide. There are 4 possibilities for which treatment participants will get; participants will receive NNC0480-0389 and semaglutide or NNC0480-0389 and placebo or placebo with semaglutide, or placebo with placebo. Participants and the responsible doctor will not know which combination participants will be given. This is called a double-blinded study. However, this information can be looked up during the study if it is important for participants' health. The study medicines will be given as injections under the skin. Participants will be in the study for about 25 weeks.

Conditions

• Healthy Volunteers
• Overweight
• Obesity
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	NNC0480-0389	Part 1: A single dose of NNC0480-0389, dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of NNC0480-0389, dose increased in each cohort.
DRUG	Semaglutide	Part 1: Single dose of semaglutide (0.5 mg). Part 2: Weekly doses of semaglutide alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.
DRUG	Placebo (NNC0480-0389)	Placebo for NNC0480-0389. Part 1: A single dose of placebo (NNC0480-0389), dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of placebo A, dose increased in each cohort.
DRUG	Placebo (semaglutide)	Part 1: Single dose of placebo (semaglutide) (0.5 mg). Part 2: Weekly doses of placebo (semaglutide) alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.

Timeline

• Start date: 2020-02-17
• Primary completion: 2022-03-16
• Completion: 2022-03-16
• First posted: 2020-02-06
• Last updated: 2023-11-13

Locations

1 site across 1 country: Netherlands