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

• 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 ]

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.

• Metabolism and Nutrition Disorder
• Obesity

• 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

• Experimental: A
  Interventions:

  • Drug: NNC 0070-0002-0349
  • Drug: placebo
• Experimental: B
  Interventions:

  • Drug: NNC 0070-0002-0349
  • Drug: placebo
• Experimental: C
  Interventions:

  • Drug: NNC 0070-0002-0349
  • Drug: placebo
• Experimental: D
  Interventions:

  • Drug: NNC 0070-0002-0349
  • Drug: placebo
• Experimental: E
  Interventions:

  • Drug: NNC 0070-0002-0349
  • Drug: placebo

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