Inspire Upper Airway Stimulation Post-FDA Approval Study
The purpose of this study is to obtain additional long-term safety and efficacy data on the use of the Inspire Upper Airway Stimulation System to treat obstructive sleep apnea.
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, followed by a 53-week open-label extension period
Rationale: The aim of the project is to develop a long-acting once-weekly GH product which is a safe and efficacious but has greater convenience and thus potentially better compliance compared to standard once daily GH treatment.
Intervention: Subjects will receive subcutaneous injection of study drug ( NNC0195-0092, Norditropin FlexPro or placebo. ) and being monitored efficacy and safety with AE, MRI, DEXA scan, Vital signs, Hts and weights, Hematology, Biochemistry, thyroid function, Hormones ,ECG and Eye exams.
Objectives or purpose: The primary objective is to access the efficacy and the secondary objective is to evaluate the clinical safety.
Study population or sample characteristics: This study is aiming for subjects who is between age of 23-79 with diagnosis of GHD who has no history of or active malignant disease.
Study methodology: Two hundred and eighty will be randomized in a 2:2:1 (NNC0195-0092: Norditropin FlexPro: placebo) ratio. The trial will compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily dosing of Norditropin FlexPro in adults with GHDs during the 35-week period (8 week dose titration, 26 week fixed dose treatment followed by 1 week washout), with a 53-week extension period (8 week dose titration, 44 week fixed dose treatment followed by 1 week washout). After the main trial period placebo subjects will be switched to NNC0195-0092 treatment and Norditropin FlexPro subjects will be randomised 1:1 to NNC0195-0092 or Norditropin FlexPro.
Study endpoints or outcomes: The primary endpoint will be at week 34 for the main trial and the secondary endpoint will be at 86 weeks for the extension period of trial. The study is looking for the outcome of changing in truncal fat mass and truncal lean body mass after the treatment, as well as to evaluate the safety of this drug.
Follow-up: Follow up visit will be scheduled 2 weeks after last treatment.
Statistics and plans for analysis: For each of the complete data sets, the change from baseline to 34 weeks is analysed using an ANCOVA model with treatment, GHD onset type, sex, region, DM and sex by region by DMinteraction as factors and the baseline truncal fat value as a covariate. From the pooled estimates, the treatment difference at Week 34 between NNC0195-0092 and placebo willbe estimated and the corresponding 95% CI and p-value will be calculated.Superiority of NNC0195-0092 over placebo will be considered confirmed if the upper boundary of
the two-sided 95% CI of the treatment difference (NNC0195-0092 placebo) is below 0. Sensitivity analysis will also be completed. Two partial database locks are planned during the trial.
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