This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the safety, tolerability, efficacy and pharmacokinetics (the rate at which the trial drug is eliminated from the body) of NNC 0070-0002-0453 in overweight/obese, but otherwise healthy male and female volunteers. Selected subjects will continue in a follow-up period of up to 5 years.
Due to an unfavourable benefit-risk profile observed during the phase 1 trial for the obesity project, NN9161, Novo Nordisk has decided to terminate further clinical development.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
117
Administration of a single subcutaneous (under the skin) dose. Up to 7 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
Administration of multiple subcutaneous (under the skin) doses for 10 weeks. Up to 4 escalating dose levels will be investigated. Progression to next dose level will be based on a safety evaluation.
Placebo will be administered as a comparator at each dose level.
Novo Nordisk Investigational Site
Evansville, Indiana, United States
Number and severity of adverse events
Time frame: From the first trial related activity (Day 1) and until completion of the post treatment follow-up visit (Day 22 +/- 1)
Terminal half-life (t½)
Time frame: After administration of a single dose of trial drug
AUC 0-24h, area under the '2-453 concentration-time curve
Time frame: From 0 to 24 hours after steady state
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