A Phase 1 interventional study of NNC0165-1562 and placebo in Metabolism and Nutrition Disorder and Obesity, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-13.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in the United States of America. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) for single doses and multiple doses of NNC0165-1562 in overweight to obese but otherwise healthy subjects.
279 studies on the registry are indexed under Nutrition Disorders; 31 are open to participants now.
This study's enrollment of 93 is below the median of 115 across 198 interventional studies indexed under Nutrition Disorders.
Browse Nutrition Disorders studies →Novo Nordisk A/S is the lead sponsor of 1,401 studies on the registry; 102 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Drug: NNC0165-1562
Drug: placebo
Administered subcutaneously (s.c., under the skin) single dose \[SD\] or multiple dose \[MD\] with daily dosing.
Administered subcutaneously (s.c., under the skin) single dose \[SD\]) or multiple dose \[MD\] with daily dosing.
Number of treatment emergent adverse events (TEAEs), Part I (SD)
Time frame: From time of dosing (Day1) until completion of the follow-up visit (Day 29)
Number of TEAEs, Part II (MD)
Time frame: From time of dosing (Day 1) until completion of the follow-up visit (Day 85)
The area under the NNC0165-1562 plasma concentration-time curve, Part I (SD)
Time frame: From time 0 to 24 hours after a single s.c. dose. From baseline (Day 1) until the follow-up visit (Day 29)
The maximum plasma concentration of NNC0165-1562 after a single s.c. dose, Part I (SD)
Time frame: From baseline (Day 1) until the follow-up visit (Day 29)
The time to maximum plasma concentration of NNC0165-1562 after a single s.c.dose, Part I (SD)
Time frame: From baseline (Day 1) until the follow-up visit (Day 29)
The area under the NNC0165-1562 plasma concentration-time curve, Part II (MD)
Time frame: From time 0 to 24 hours at steady state. From baseline (Day 1) until the follow-up visit (Day 85)
The maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)
Time frame: From baseline (Day 1) until the follow-up visit (Day 85)
The time to maximum plasma concentration of NNC0165-1562 at steady state, Part II (MD)
Time frame: From baseline (Day 1) until the follow-up visit (Day 85)
Ran from Oct 2015 to primary completion in Feb 2017, 16 months.
Of 21 phase 1 interventional studies under Nutrition Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 16. This study's 16 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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