somapacitan
Sponsors
Novo Nordisk A/S
Conditions
Adult Growth Hormone DeficiencyDiabetes Mellitus Type 2Growth Hormone DeficiencyGrowth Hormone Deficiency in ChildrenGrowth Hormone DisorderHealthyHealthy VolunteersISS
Phase 1
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
CompletedNCT01514500
Start: 2012-01-16End: 2013-03-18Updated: 2020-12-24
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
CompletedNCT01706783
Start: 2012-10-12End: 2013-11-18Updated: 2020-12-24
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
CompletedNCT01973244
Start: 2013-12-16End: 2014-11-04Updated: 2020-12-24
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
CompletedNCT02962440
Start: 2016-11-30End: 2017-01-31Updated: 2017-06-07
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
CompletedNCT03186495
Start: 2017-06-20End: 2018-05-17Updated: 2020-04-17
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.
CompletedNCT03212131
Start: 2017-08-16End: 2018-03-08Updated: 2019-05-24
A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects
CompletedNCT03905850
Start: 2019-03-29End: 2019-07-15Updated: 2019-08-06
Phase 2
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
CompletedNCT02616562
Start: 2016-03-31End: 2024-09-26Updated: 2026-01-16
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Active, not recruitingNCT03878446
Start: 2019-07-04End: 2026-12-23Updated: 2026-08-13
Phase 3
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
CompletedNCT02229851
Start: 2014-10-31End: 2018-05-07Updated: 2020-11-23
A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency
CompletedNCT02382939
Start: 2015-02-12End: 2016-01-04Updated: 2020-07-09
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
CompletedNCT03075644
Start: 2017-03-03End: 2018-10-04Updated: 2020-11-23
A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)
CompletedNCT03811535
Start: 2019-05-20End: 2025-09-30Updated: 2026-05-22
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.
CompletedNCT04970654
Start: 2021-07-22End: 2023-12-18Updated: 2026-01-06
A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow
Active, not recruitingNCT05330325
Start: 2022-08-10End: 2027-10-29Updated: 2026-06-12
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
Active, not recruitingNCT05723835
Start: 2023-02-01End: 2027-10-29Updated: 2026-08-13
Unknown Phase
Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®
Active, not recruitingNCT05230550
Start: 2022-02-03End: 2026-12-31Target: 200Updated: 2026-04-13
A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information
Enrolling by invitationNCT05718570
Start: 2023-02-03End: 2032-12-15Target: 400Updated: 2026-06-12
Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed
Enrolling by invitationNCT06109935
Start: 2023-10-04End: 2026-12-31Target: 200Updated: 2026-04-29
A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters
Enrolling by invitationNCT06709040
Start: 2024-12-13End: 2034-04-14Target: 500Updated: 2026-04-06
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