NCT04010786

A Research Study Investigating NNC0247-0829 for Weight Management in People With Overweight or Obesity

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Subcutaneous Injections of NNC0247-0829 in Adults With Overweight or Obesity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study looks at NNC0247-0829 (a potential new medicine) for weight management in people with overweight or obesity. The study looks at how NNC0247-0829 works in the body. Participants will either get NNC0247-0829 or placebo (a 'dummy' medicine) - which treatment is decided by chance. NNC0247-0829 is an experimental medicine which has not been approved by the US FDA. Participants will get either 1 injection or a total of 4 injections (one week apart) by a study nurse at the clinic depending on what group they are in. The study will last for about 18 months, but participation will last from 11 to 23 weeks. This will depend on the group participants are in. Participants will attend 8 to 14 visits at the clinic with the study staff. Some participants will have one 16-day, 15-night visit and one 2-day, 1-night visit. Others will have two 2-day, 1-night visits. At all visits except one, participants will have blood tests and other checks. They will be asked about their health, medical history and habits including mental health questionnaires.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	NNC0247-0829	Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.
DRUG	Placebo (NNC0247-0829)	Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.

Timeline

• Start date: 2019-07-11
• Primary completion: 2022-06-11
• Completion: 2022-06-21
• First posted: 2019-07-08
• Last updated: 2024-01-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study