NCT00665665

Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Male and Female Volunteers

Safety, Efficacy, Tolerability and Pharmacokinetics of NNC 0070-0002-0182 in Overweight or Obese Healthy Male and Female Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial will be conducted in the United States of America (USA). The aim of the trial is to investigate whether the drug is safe, well tolerated and to investigate the efficacy of NNC 0070-0002-0182 for the treatment of obesity. The subjects will be treated with drug and placebo. This registration covers the phase 2 part of a combined phase 1/phase 2 trial (phase 1 part of trial conducted between November 2007 and April 2008).

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	NNC 0070-0002-0182	4mg initial dose (12 subjects active; 3 subjects placebo); 2mg weekly maintenance dose; for s.c. injection 20mg/vial
DRUG	placebo	Placebo for s.c. injection
DRUG	NNC 0070-0002-0182	12mg initial dose (12 subjects active; 3 subjects placebo); 6mg weekly maintenance dose; for s.c. injection 20mg/vial
DRUG	NNC 0070-0002-0182	32mg initial dose (12 subjects active; 3 subjects placebo); 16mg weekly maintenance dose; for s.c. injection 20mg/vial
DRUG	NNC 0070-0002-0182	60mg initial dose (12 subjects active; 3 subjects placebo); 30mg weekly maintenance dose; for s.c. injection 20mg/vial

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-04-24
• Last updated: 2016-12-23

Locations

2 sites across 1 country: United States