NCT03707990

A Research Study of NNC0165-1875 Alone or Together With Semaglutide in People Who Are Overweight or Obese

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Single Doses of NNC0165-1875 as Monotherapy and in Combination With Semaglutide in Subjects With Overweight or Obesity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: —
• Healthy volunteers: Accepted

Summary

The study is looking at possible new medicines for weight control in people with high body weight. The study looks at how the new medicines work in the body. The study consists of two parts. If participants take part in Part 1, they will either get a single dose of NNC0165-1875 or a "dummy" medicine (placebo). If participants take part in Part 2, they will either get a single dose of NNC0165-1875 or "dummy" medicine and also a single dose of semaglutide. Which treatment participants get is decided by chance. For Part 1 participants will get 1 injection. For Part 2 participants will get 2 injections. A study nurse at the clinic will inject the medicine with a thin needle in a skin fold in the stomach. The study will last for about 9 weeks. Participants will have 7 visits to the clinic with the study doctor.

Conditions

• Obesity and Overweight

Interventions

Type	Name	Description
DRUG	NNC0165-1875	Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg.
DRUG	Placebo (NNC0165-1875)	Participants will receive a single dose of s.c. placebo injection.
DRUG	Semaglutide	Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.

Timeline

• Start date: 2018-10-15
• Primary completion: 2019-08-13
• Completion: 2019-08-13
• First posted: 2018-10-16
• Last updated: 2019-09-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study