Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03075644 | A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency | PHASE3 | COMPLETED | 62 | — | — | Mar 3, 2017 | Oct 4, 2018 | Nov 23, 2020 | 12 | Japan |
| NCT02229851 | Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. | PHASE3 | COMPLETED | 301 | — | — | Oct 31, 2014 | May 7, 2018 | Nov 23, 2020 | 117 | United States, Australia +17 |
| NCT02616562 | Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency | PHASE2 | COMPLETED | 76 | — | — | Mar 31, 2016 | Sep 26, 2024 | Jan 16, 2026 | 89 | United States, Austria +12 |
| NCT03212131 | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function. | PHASE1 | COMPLETED | 34 | — | — | Aug 16, 2017 | Mar 8, 2018 | May 24, 2019 | 1 | Slovakia |
| NCT03186495 | Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function | PHASE1 | COMPLETED | 44 | — | — | Jun 20, 2017 | May 17, 2018 | Apr 17, 2020 | 1 | Germany |
| NCT01973244 | A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency | PHASE1 | COMPLETED | 32 | — | — | Dec 16, 2013 | Nov 4, 2014 | Dec 24, 2020 | 22 | Austria, Belgium +8 |
| 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 | PHASE1 | COMPLETED | 35 | — | — | Oct 12, 2012 | Nov 18, 2013 | Dec 24, 2020 | 4 | Denmark, Sweden |
| NCT01514500 | First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects | PHASE1 | COMPLETED | 105 | — | — | Jan 16, 2012 | Mar 18, 2013 | Dec 24, 2020 | 1 | Germany |
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment. Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented.
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 26 as: HV = (height at 26 weeks visit- height at baseline) / (time from baseline to 26 weeks visit in years).
This primary outcome measure was analysed by cohort using descriptive statistics. Adverse event per 100 patient years are presented in this outcome measure.
Calculated based on somapacitan measured in blood
| Arm | Type | Description |
|---|---|---|
| Somapacitan | EXPERIMENTAL | - |
| Norditropin | ACTIVE_COMPARATOR | - |
| NNC0195-0092 (somapacitan) | EXPERIMENTAL | - |
| Daily hGH | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Switch to NNC0195-0092 (somapacitan) treatment in the extension period. |
| Cohort I Norditropin/somapacitan | EXPERIMENTAL | Participants received Norditropin subcutaneously daily in main trial period, extension trial period and safety extension trial period. After completing the safety extension trial period (week 156), participants who received Norditropin were allocated to open-labelled Somapacitan dose 3 subcutaneously once weekly for the 208-week (up till week 364) long-term safety extension period. After week 364, participants received somapacitan dose 3 subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest. |
| Cohort I somapacitan pooled | EXPERIMENTAL | Participants were randomized (1:1:1) to receive Somapacitan treatment (dose 1/dose 2/dose 3) subcutaneously once-weekly during the 26-week main trial period and the 26-week extension trial period. After completing the main and extension trial periods (week 52), all participants initially randomized to double-blinded Somapacitan received open-labelled Somapacitan dose 3 for the 104-week safety extension trial period. After completing the safety extension trial period (week 156), all participants in cohort I were allocated to open-labelled somapacitan dose 3 for the 208-week (up till week 364) long-term safety extension period. In extension after week 364 period participants received somapacitan dose 3 subcutaneously once weekly until somapacitan was available for prescription for children with GHD in their country or until August 2024, at the latest. |
| Cohort II somapacitan previously treated | EXPERIMENTAL | Participant who was previously treated with GH (Growth hormone) prior to enrollment in the trial at week 156, received somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest. |
| Cohort III somapacitan treatment naive | EXPERIMENTAL | Participants who were naive to treatment with GH prior to enrolment in the trial at week 156, received open-labelled somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest. |
| Cohort III somapacitan previously treated | EXPERIMENTAL | Participants who were previously treated with GH prior to enrollment in the trial at week 156, received open-labelled somapacitan dose 3 subcutaneously once weekly until it was available for prescription in participants' respective countries or until August 2024, at the latest. |
| Normal hepatic function | EXPERIMENTAL | Subjects with normal hepatic function |
| Mild hepatic impairment | EXPERIMENTAL | Subjects with mild hepatic impairment |
| Moderate hepatic impairment | EXPERIMENTAL | Subjects with moderate hepatic impairment |
| Normal renal function | EXPERIMENTAL | Subjects with normal renal function |
| Mild renal impairment | EXPERIMENTAL | Subjects with mild renal impairment |
| Moderate renal impairment | EXPERIMENTAL | Subjects with moderate renal impairment |
| Severe renal impairment | EXPERIMENTAL | Subjects with severe renal impairment |
| Requiring haemodialysis treatment | EXPERIMENTAL | Subjects requiring haemodialysis treatment |
| Norditropin® | ACTIVE_COMPARATOR | - |
| Norditropin NordiFlex® | ACTIVE_COMPARATOR | - |
| Single dose (SD) | EXPERIMENTAL | Single dose administered s.c. (subcutaneously, under the skin). Escalation to the next dose level will be based on safety evaluation |
| Multiple dose (MD) | EXPERIMENTAL | Multiple doses administered s.c. (subcutaneously, under the skin). All subjects will be dosed four times with a dosing frequency of once weekly. Escalation to the next dose level will be based on safety evaluation |
| Name | Type | Description |
|---|---|---|
| somapacitan | DRUG | Once weekly subcutaneous injections (s.c., under the skin) |
| Norditropin | DRUG | Daily subcutaneous injections (s.c., under the skin) |
| somatropin | DRUG | Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration. |
| placebo | DRUG | Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. |
| Norditropin® FlexPro® pen | DRUG | Administered subcutaneously (s.c., under the skin) once daily. |
| Norditropin NordiFlex® | DRUG | 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 |
| placebo (somapacitan) | DRUG | Single or multiple placebo doses administered s.c. (subcutaneously, under the skin) |
Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at sc...