NCT00728455

Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers

Single Subcutaneous Dose Rising Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0349 in Overweight/Obese Male Subjects

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated. Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated. Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.

Conditions

• Metabolism and Nutrition Disorder
• Obesity

Interventions

Type	Name	Description
DRUG	NNC 0070-0002-0349	Dose level 1: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
DRUG	NNC 0070-0002-0349	Dose level 2: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
DRUG	NNC 0070-0002-0349	Dose level 3: (6 subjects active, 2 subjects placebo). Subjects administered NNC 0070-0002-0349 will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
DRUG	NNC 0070-0002-0349	Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo)
DRUG	NNC 0070-0002-0349	Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo)
DRUG	placebo	Dose level 1: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
DRUG	placebo	Dose level 2: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
DRUG	placebo	Dose level 3: NNC 0070-0002-0349 placebo. Subjects administered placebo will receive a subcutaneous injection. Subjects in the first 3 dose groups will receive two injections: one of randomized treatment (drug or placebo) and placebo
DRUG	placebo	Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection
DRUG	placebo	Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection

Timeline

• Start date: 2008-07-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2008-08-05
• Last updated: 2014-10-17