Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Somapacitan · 16 trials · 12 indications
This outcome measure reported number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
This outcome measure reported number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
This outcome measure reported number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
This outcome measure reported number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Measured in centimeter per year (cm/year)
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).
Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.
Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.
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.
An adverse event can be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Presented results are event rate per 100 patient years of exposure.
Presented results are event (injection site reaction) rate per 100 patient years of exposure.
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.
ng\*h/mL
ng/mL
Calculated based on somapacitan measured in blood
| Arm | Type | Description |
|---|---|---|
| Somapacitan | EXPERIMENTAL | Participants will receive Somapacitan for 26-week main phase followed by 130-week extension phase. |
| Norditropin® | ACTIVE_COMPARATOR | Participants will receive Norditropin® for 52 weeks (main treatment period) and Somapacitan for 221 weeks (extension period) |
| Somapacitan weekly | EXPERIMENTAL | participants will receive once-weekly somapacitan for 52 weeks |
| Norditropin® daily | ACTIVE_COMPARATOR | Participants will receive Norditropin® daily for 52 weeks |
| Norditropin | ACTIVE_COMPARATOR | - |
| hGH (somatropin) | ACTIVE_COMPARATOR | - |
| NNC0195-0092 (somapacitan) | EXPERIMENTAL | - |
| Daily hGH | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Switch to NNC0195-0092 (somapacitan) treatment in the extension period. |
| Somapacitan 0.24 mg/kg/week | EXPERIMENTAL | Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
| Somapacitan 0.20 mg/kg/week | EXPERIMENTAL | Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
| Somapacitan 0.16 mg/kg/week | EXPERIMENTAL | Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
| Norditropin® 0.035 mg/kg/day | ACTIVE_COMPARATOR | Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
| Norditropin® 0.067 mg/kg/day | ACTIVE_COMPARATOR | Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase. |
| 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. |
| Somapacitan 5/10/10 mg | EXPERIMENTAL | One dose of somapacitan 5 mg/1.5 ml followed by two doses of somapacitan 10 mg/1.5 ml. Each dose will be followed by a 3 week observation period. |
| Somapacitan 10/5/10 mg | EXPERIMENTAL | One dose of somapacitan 10 mg/1.5 ml followed by a 5 mg/1.5 ml dose followed by a 10 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. |
| Somapacitan 10/10/5 mg | EXPERIMENTAL | Two doses of 10 mg/1.5 ml somapacitan followed by a 5 mg/1.5 ml dose. Each dose will be followed by a 3 week observation period. |
| 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 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 | Somapacitan 0.24 milligrams per kilograms per week (mg/kg/week) will be administered subcutaneously (s.c.) using PDS290 pen-injector. |
| Norditropin® | DRUG | Norditropin® will be administered s.c. once daily using FlexPro® pen-injector. |
| Norditropin | DRUG | Daily subcutaneous injections (s.c., under the skin) |
| somatropin | DRUG | Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout. |
| 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: Applicable to children with SGA: * Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards). * Age: \- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening. \- Female...
Somapacitan is an investigational drug being studied for growth disorders, including short stature in children born small for gestational age (SGA), growth hormone deficiency in children and adults, Turner Syndrome, Noonan Syndrome, and idiopathic short stature (ISS). It is currently in Phase 3 clinical development.
Somapacitan is being developed by Novo Nordisk A/S, a pharmaceutical company listed on the stock exchange under the ticker NVO. The company is conducting clinical trials to evaluate the drug's safety and efficacy in children and adults with growth-related conditions.
Somapacitan is in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials to assess its safety and effectiveness for treating growth disorders.
Somapacitan has been studied in several clinical trials, including NCT02962440 (a Phase 1 study in healthy volunteers), NCT03878446 (a Phase 2 study in children born small for gestational age), NCT05330325 (a Phase 3 study in children with SGA, Turner Syndrome, Noonan Syndrome, or ISS), and NCT05723835 (a Phase 3 study in children needing growth help).
No, Somapacitan is not the same as Norditropin. Somapacitan is an investigational drug being developed by Novo Nordisk, while Norditropin is an existing growth hormone product. Clinical trials are comparing Somapacitan, given once a week, against Norditropin, given once a day, to evaluate their effects.