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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00728455
• Other study ID #: NN9112-1905
• Status: Withdrawn
• Phase: Phase 1
• First received: July 31, 2008
• Last updated: October 16, 2014
• Start date: July 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2014
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metabolism and Nutrition Disorder
• Nutrition Disorders
• Obesity

Intervention

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
• 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
• 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
• NNC 0070-0002-0349
Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo)
• NNC 0070-0002-0349
Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo)
• 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
• 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
• 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
• placebo
Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection
• placebo
Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)		Including screening and evaluation: after approx. 7 weeks	Yes
Secondary	AUC (area under the curve)		21 days following dosing	Yes
Secondary	Maximum plasma concentration		21 days following dosing	No
Secondary	Time to maximum plasma concentration		21 days following dosing	No
Secondary	Half life		21 days following dosing	No

External Links

•   Clinical Trials at Novo Nordisk