NCT03574584

A Research Study of NNC0165-1562 and Semaglutide in People Who Are Overweight or Obese

An Ascending Dose Trial Investigating Safety, Tolerability and Pharmacokinetics of Multiple Weekly Doses of NNC0165-1562 and Semaglutide in Subjects With Overweight or Obesity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

The study is investigating new medicines for weight control in people with high body weight. The study looks at how the study medicines work in the body. Participants will get semaglutide and either NNC0165-1562 or "dummy" medicine -which treatment participants get is decided by chance. Participants will get 2 injections per week for 5 months. 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 7 months. Participants will have 27 visits to the clinic.

Conditions

• Metabolism and Nutrition Disorders
• Overweight or Obesity

Interventions

Type	Name	Description
DRUG	NNC0165-1562	Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
DRUG	Semaglutide	Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
DRUG	Placebo (NNC0165-1562)	Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.

Timeline

• Start date: 2018-06-18
• Primary completion: 2019-07-27
• Completion: 2019-07-27
• First posted: 2018-07-02
• Last updated: 2021-07-02

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study