4054 - REAL 1 NNC0195-0092 in adults with growth hormone deficiency
Research type
Research Study
Full title
A multicentre, multinational, randomised, parallel-group, placebo-controlled (double blind) and active-controlled (open) trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, with a 53-week extension period
IRAS ID
162389
Contact name
Andrew Toogood
Contact email
Sponsor organisation
Novo Nordisk A/S
Eudract number
2013-002892-16
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This study is designed to assess the safety and efficacy of once weekly dosing with NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency for 35 weeks, with a 53-week extension period.
The assignment of treatment for the NNC0195-0092 and placebo will be done in a randomised, double blind manner, Norditropin will be open labelled - all assignments are done via an interactive voice response system (IVRS). This will be done in a 2:1:2 manner for MMC0195-0092:placebo:Norditropin.
During the first 8 weeks of the main phase and the extension phase titration of the patients' dose will take place. After the titration period patients will take a fixed dose of trial product.
Patients that were allocated to receive placebo during the main phase of the trial will be switched to receive NNC0195-0092 during the extension phase. This will be done in a double blinded fashion. 50% of patients who were on the Norditropin in the main phase will transfer to receive the NNC0195-0092 product in the extension phase.
The primary endpoint for this study is the change from baseline to end of main trial period (Week 34) in truncal fat percentage. This will be measured using DXA scans.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
14/WM/1188
Date of REC Opinion
20 Nov 2014
REC opinion
Further Information Favourable Opinion