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

Novo Nordisk

Status and phase: Withdrawn; Phase 1

Conditions: Metabolism and Nutrition Disorder; Obesity

Treatments: Drug: placebo; Drug: NNC 0070-0002-0349

Study type: Interventional

Funder types: Industry

Identifiers

NCT00728455

NN9112-1905

Details and patient eligibility

About

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.

Sex: Male

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 5 patient groups

A

Experimental group

Treatment:

Drug: placebo

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

B

Experimental group

Treatment:

Drug: placebo

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

C

Experimental group

Treatment:

Drug: placebo

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

D

Experimental group

Treatment:

Drug: placebo

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

E

Experimental group

Treatment:

Drug: placebo

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349

Drug: placebo

Drug: NNC 0070-0002-0349