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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00728455
First Posted: August 5, 2008
Last Update Posted: October 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novo Nordisk A/S
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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

Further study details as provided by Novo Nordisk A/S:

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 ]

Secondary Outcome Measures:
  • AUC (area under the curve) [ Time Frame: 21 days following dosing ]
  • Maximum plasma concentration [ Time Frame: 21 days following dosing ]
  • Time to maximum plasma concentration [ Time Frame: 21 days following dosing ]
  • Half life [ Time Frame: 21 days following dosing ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00728455


Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00728455     History of Changes
Other Study ID Numbers: NN9112-1905
First Submitted: July 31, 2008
First Posted: August 5, 2008
Last Update Posted: October 17, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
Overweight
Nutrition Disorders
Body Weight
Signs and Symptoms