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

Purpose

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.

Condition	Intervention	Phase
Metabolism and Nutrition Disorder Obesity	Drug: NNC 0070-0002-0349 Drug: placebo	Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Obesity

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG) [ Time Frame: Including screening and evaluation: after approx. 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

AUC (area under the curve) [ Time Frame: 21 days following dosing ] [ Designated as safety issue: Yes ]
Maximum plasma concentration [ Time Frame: 21 days following dosing ] [ Designated as safety issue: No ]
Time to maximum plasma concentration [ Time Frame: 21 days following dosing ] [ Designated as safety issue: No ]
Half life [ Time Frame: 21 days following dosing ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	July 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: A	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: 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
Experimental: B	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: 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
Experimental: C	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: 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
Experimental: D	Drug: NNC 0070-0002-0349 Dose level 4 for s.c. injection (6 subjects active, 2 subjects placebo) Drug: placebo Dose level 4: NNC 0070-0002-0349 placebo for s.c. injection
Experimental: E	Drug: NNC 0070-0002-0349 Dose level 5 for s.c. injection (6 subjects active, 2 subjects placebo) Drug: placebo Dose level 5: NNC 0070-0002-0349 placebo for s.c. injection

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728455

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

William Lyness, PhD

Novo Nordisk

More Information

Additional Information:

Clinical Trials at Novo Nordisk This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier:	NCT00728455 History of Changes
Other Study ID Numbers:	NN9112-1905
Study First Received:	July 31, 2008
Last Updated:	June 26, 2012
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Nutrition Disorders
Obesity
Overweight

Overnutrition
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013