NCT01706783View on ClinicalTrials.gov

A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

PHASE1CompletedINTERVENTIONAL
Enrollment

35

Participants

Timeline

Start Date

October 12, 2012

Primary Completion Date

November 18, 2013

Study Completion Date

November 18, 2013

Conditions
Growth Hormone DisorderAdult Growth Hormone Deficiency
Interventions
DRUG

somapacitan

Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order

DRUG

Norditropin NordiFlex®

Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency

Trial Locations (4)

2100

Novo Nordisk Investigational Site, København Ø

5000

Novo Nordisk Investigational Site, Odense

8000

Novo Nordisk Investigational Site, Århus C

141 86

Novo Nordisk Investigational Site, Stockholm

Sponsors

Lead Sponsor

Novo Nordisk A/S
All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT01706783 - A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency | Biotech Hunter | Biotech Hunter