NCT02568306

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects

A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses and Multiple Doses of NNC0165-1562 in Overweight to Obese But Otherwise Healthy Subjects.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial is conducted in the United States of America. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	NNC0165-1562	Administered subcutaneously (s.c., under the skin) single dose \[SD\] or multiple dose \[MD\] with daily dosing.
DRUG	placebo	Administered subcutaneously (s.c., under the skin) single dose \[SD\]) or multiple dose \[MD\] with daily dosing.

Timeline

• Start date: 2015-10-05
• Primary completion: 2017-02-07
• Completion: 2017-02-07
• First posted: 2015-10-05
• Last updated: 2018-07-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study