A Phase 1 interventional study of NNC 0070-0002-0453 and '2-0453 in Metabolism and Nutrition Disorder and Obesity, sponsored by Novo Nordisk A/S. Terminated at 1 site in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-07-27.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.
This study's enrollment of 117 is above the median of 78 across 4,878 interventional studies indexed under Obesity.
Browse Obesity studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: NNC 0070-0002-0453 · Drug: placebo
Drug: '2-0453 · Drug: placebo
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.
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
This study is terminated, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S