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

Phase 1

Withdrawn

• Conditions: Obesity; Metabolism and Nutrition Disorder
• Interventions: Drug: NNC 0070-0002-0349; Drug: placebo

• Registration Number: NCT00728455
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-07-31
• Study First Posted: 2008-08-05
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-16
• Last Update Posted: 2014-10-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

• BMI greater than 27.0 and less than 35.0 kg/m2

Exclusion Criteria

• Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg
• Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item)
• Eating disorders
• Unusual diets or eating habits
• Dieting, use of diet drugs or obesity surgery
• Diabetes history or abnormal fasting glucose

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	NNC 0070-0002-0349	-
E	placebo	-
A	NNC 0070-0002-0349	-
A	placebo	-
C	NNC 0070-0002-0349	-
D	NNC 0070-0002-0349	-
B	placebo	-
C	placebo	-
D	placebo	-
E	NNC 0070-0002-0349	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)	Including screening and evaluation: after approx. 7 weeks

Secondary Outcome Measures

Name	Time	Method
Time to maximum plasma concentration	21 days following dosing
Maximum plasma concentration	21 days following dosing
AUC (area under the curve)	21 days following dosing
Half life	21 days following dosing