Somapacitan vs Norditropin for Growth Disorders
(REAL 8 Trial)
Recruiting in Palo Alto (17 mi)
+326 other locations
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Novo Nordisk A/S
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial compares two growth hormone treatments for children with growth issues. Somapacitan is a new treatment, while Norditropin® is an existing treatment. The study aims to find out which treatment helps these children grow better. Somapacitan is a long-acting growth hormone derivative in development for treatment of GH deficiency.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop all current medications. However, you cannot have had prior growth-promoting therapy, and certain medications affecting growth, like systemic corticosteroids or treatments for ADHD, are not allowed. Thyroid hormone therapy must be stable for 90 days if applicable.
What data supports the idea that Somapacitan vs Norditropin for Growth Disorders is an effective treatment?
The available research shows that Somapacitan, which is taken once a week, is designed to be more convenient compared to Norditropin, which is taken daily. This convenience can lead to better treatment satisfaction. For Norditropin, studies have shown that it effectively increases height in children with growth disorders, such as Noonan syndrome, over a two-year period. While the research does not directly compare the effectiveness of Somapacitan and Norditropin in terms of growth outcomes, the convenience of Somapacitan's weekly dosage could improve patient compliance, which is important for long-term treatment success.
12345What safety data is available for Somapacitan and Norditropin in treating growth disorders?
The provided research does not contain safety data for Somapacitan, Norditropin, or related names such as Somatropin, Sogroya, somapacitan-beco, or NNC0195-0092. The studies focus on unrelated treatments and conditions.
678910Is the drug Norditropin® (Somapacitan) promising for treating growth disorders?
Yes, Norditropin® (Somapacitan) is promising for treating growth disorders because it offers the convenience of once-weekly dosing, which can improve patient satisfaction and compliance compared to daily treatments. It has been shown to be effective in both adults and children with growth hormone deficiency.
12111213Eligibility Criteria
This trial is for children who were born small and remain small, or have Turner Syndrome, Noonan Syndrome, or idiopathic short stature. They must not have had growth-promoting therapy before and meet specific criteria related to age, puberty status, BMI, and height. Children with certain medical conditions or on conflicting medications are excluded.Inclusion Criteria
My son is between 2.5 and 11 years old with small testes.
I, or my legal guardian, have given permission for me to participate in this study.
My son is between 2.5 and 11 years old with small testes.
+8 more
Exclusion Criteria
Any disorder, which in the investigator's opinion, might jeopardize participant's safety or compliance with the protocol
The participant or the parent/legally acceptable representative is likely to be non-compliant in respect to study conduct, as judged by the investigator
My child has been on high-dose asthma medication for more than a month in the past year.
+16 more
Participant Groups
The study compares somapacitan (a new medicine given once a week) with Norditropin® (an existing treatment taken daily). Over three years, participants will either receive somapacitan the whole time or start with Norditropin® for one year followed by somapacitan for two years. The assignment of treatments is random.
2Treatment groups
Experimental Treatment
Active Control
Group I: SomapacitanExperimental Treatment1 Intervention
Participants will receive Somapacitan for 156 weeks
Group II: Norditropin®Active Control1 Intervention
Participants will receive Norditropin® for 52 weeks (main phase) and Somapacitan for 104 weeks (extension phase)
Norditropin® is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Norditropin for:
- Pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH)
- Short stature associated with Noonan syndrome
- Short stature associated with Turner syndrome
- Short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years
- Idiopathic Short Stature (ISS)
- Growth failure due to Prader-Willi syndrome (PWS)
- Replacement of endogenous GH in adults with growth hormone deficiency (GHD)
🇪🇺 Approved in European Union as Norditropin for:
- Pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone (GH)
- Short stature associated with Noonan syndrome
- Short stature associated with Turner syndrome
- Short stature born small for gestational age (SGA) with no catch-up growth by age 2 to 4 years
- Idiopathic Short Stature (ISS)
- Growth failure due to Prader-Willi syndrome (PWS)
- Replacement of endogenous GH in adults with growth hormone deficiency (GHD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Novo Nordisk Investigational SiteMorristown, NJ
Novo Nordisk Investigational SiteKansas City, MO
Novo Nordisk Investigational SiteCentennial, CO
UPMC Child Hosp-PittsburghPittsburgh, PA
More Trial Locations
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Who Is Running the Clinical Trial?
Novo Nordisk A/SLead Sponsor
References
Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial. [2019]Label="OBJECTIVE" NlmCategory="OBJECTIVE">Somapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin®. Local tolerability and treatment satisfaction were also assessed.
Norditropin SimpleXx: a liquid human growth hormone formulation, a pen system and an auto-insertion device. [2022]Patient compliance is of vital importance for the outcome of any medical therapy. Compliance is especially a problem in long-term treatment of non-life threatening diseases, such as growth retardation in children. Until recently, all human growth hormone (hGH) products required a reconstitution process. Norditropin((R)) SimpleXx(TM) is a liquid formulation of the biosynthetic hGH product Norditropin((R)), and, together with an improved NovoPen((R)) 1.5, NordiPen(TM), and an auto-insertion device, PenMate(TM)/NordiPenMate(TM), it has been developed in order to ease the injection process for patients. A randomized, open, multicentre, crossover trial compared Norditropin((R)) SimpleXx(TM)/improved NovoPen((R)) 1.5 with freeze-dried Norditropin((R)) PenSet((R))/Nordiject((R)). A total of 67 children with GH deficiency, aged 5-18 years, were treated with either Norditropin((R)) SimpleXx(TM) for 6 weeks followed by Norditropin((R)) for 6 weeks or the opposite (sequences I and II, respectively). Acceptability/convenience and pain perception were evaluated by questionnaire after each period. The function and handling of the PenMate(TM) were evaluated in a Dutch trial by 27 GH-treated children with intrauterine growth retardation, aged 4-16 years, and their parents. All children were accustomed to using the Nordiject((R)) pen. The evaluation of the PenMate(TM) was based on a questionnaire. A similar trial was conducted in England, in which the NordiPen(TM) and the NordiPenMate(TM) were evaluated by 25 GH-treated children and their parents. Norditropin((R)) SimpleXx(TM) was found to be easier to inject by 64% of the children, and 98% of the children found the system easier to use overall. There was no difference in pain perception between the two administration systems, as judged by questionnaires and visual analogue scale score. Three out of four patients preferred to continue treatment with Norditropin((R)) SimpleXx(TM). The safety profiles of the two systems were similar. In the Dutch trial, the PenMate(TM) was found to be easy and safe to handle, even for very young children (aged 4-5 years). Of patients who took a long time to get used to the injections, 73% found that the new pen would help. A total of 88% of the children would prefer to use the PenMate(TM) in the future. Positive results of the handling tests were also reported in the British trial. The use of Norditropin((R)) SimpleXx(TM) and the auto-insertion device may improve patient compliance.
Comparison of response to 2-years' growth hormone treatment in children with isolated growth hormone deficiency, born small for gestational age, idiopathic short stature, or multiple pituitary hormone deficiency: combined results from two large observational studies. [2022]Few studies have compared the response to growth hormone (GH) treatment between indications such as isolated growth hormone deficiency (IGHD), born small for gestational age (SGA), idiopathic short stature (ISS), and multiple pituitary hormone deficiency (MPHD). The aim of this analysis of data, collected from two large ongoing observational outcome studies, was to evaluate growth and insulin-like growth factor-I (IGF-I) response data for children of short stature with IGHD, MPHD, SGA, or ISS following two years of treatment with the recombinant GH product Norditropin® (Novo Nordisk A/S, Bagsværd, Denmark).
Efficacy and safety of two doses of Norditropin® (somatropin) in short stature due to Noonan syndrome: a 2-year randomized, double-blind, multicenter trial in Japanese patients. [2022]This randomized double-blind multicenter trial (NCT01927861) evaluated the growth-promoting effect and safety of Norditropin® (NN220; somatropin) in Japanese children with short stature due to Noonan syndrome. Prepubertal children aged 3-<11 years (boys) or 3-<10 years (girls) with Noonan syndrome were randomized to receive GH 0.033 mg/kg/day (n = 25, mean age 6.57 years, 11 females) or 0.066 mg/kg/day (n = 26, mean age 6.06 years, eight females) for 104 weeks. Change in height standard deviation score (HSDS) from baseline was analyzed based on an ANCOVA model. Baseline HSDS was -3.24. Estimated change in HSDS [95% CI] after 104 weeks' treatment was 0.84 [0.66, 1.02] and 1.47 [1.29, 1.64] for the lower and higher doses, respectively; estimated mean difference 0.63 [0.38, 0.88], p < 0.0001. Rates and patterns of adverse events (AEs) were similar between groups. Most were mild and reported as unlikely to be related to Norditropin®. There were no withdrawals due to AEs. Insulin-like growth factor-I SDS increased from -1.71 to -0.64 (0.033 mg/kg/day) and to 0.63 (0.066 mg/kg/day). HbA1c increased slightly (0.033 mg/kg/day: +0.14%; 0.066 mg/kg/day: +0.13%); glucose profiles were almost unchanged; insulin profiles increased in both groups in the oral glucose tolerance test. There were no clinically significant abnormal electrocardiogram or echocardiography findings. We conclude that Norditropin® at doses of 0.033 mg/kg/day or 0.066 mg/kg/day for 104 weeks increases height in Japanese children with short stature due to Noonan syndrome, with a favorable safety profile. The effect was greater with 0.066 mg/kg/day compared with 0.033 mg/kg/day.
Clinicians' Feedback on Patient/Carer Experience After Switching of Growth Hormone Treatment in Pediatric Patients During COVID-19. [2022]Label="PURPOSE" NlmCategory="OBJECTIVE">This study investigated why some clinicians switched growth hormone (GH) brands in pediatric patients with GH-related disorders to Norditropin® since the start of the COVID-19 pandemic, the clinicians' perceptions of the results, and whether observations from this period of disruption could inform clinical practice in the future.
Safety, adherence and discontinuation in varenicline solution nasal spray clinical trials for dry eye disease. [2023]Aim: Herein, we report safety outcomes for varenicline solution nasal spray (VNS) within the context of clinical trial discontinuation, contrasting those with discontinuation outcomes from topical cyclosporine and lifitegrast clinical trials. Materials & methods: 1061 subjects were randomized across three clinical trials to receive either VNS 0.06 mg, VNS 0.03 mg, VNS 0.006 mg or vehicle control. Subjects who discontinued from treatment were noted and assigned to their appropriate categories. Results: Despite treatment emergent adverse events, 93.5% of subjects receiving VNS completed the treatment period. By comparison, only 80% of subjects in the integrated clinical trials for cyclosporine ophthalmic emulsion and 91% of subjects in the integrated trials for lifitegrast ophthalmic solution completed the full treatment period, respectively. Conclusion: In clinical trials, VNS demonstrated improvements in dry eye disease signs and symptoms, was well-tolerated, and had an overall completion rate >93%. Conventional dry eye treatments (e.g., cyclosporine and lifitegrast) noted considerably higher discontinuation rates in their clinical trials.
Bimatoprost ophthalmic solution 0.03% lowered intraocular pressure of normal-tension glaucoma with minimal adverse events. [2021]The aim of this study was to evaluate the efficacy and safety of bimatoprost ophthalmic solution 0.03% (bimatoprost) in Japanese normal-tension glaucoma (NTG) patients with an intraocular pressure (IOP) of 18 mmHg or less.
Effects of beraprost sodium, an oral prostacyclin analogue, in patients with pulmonary arterial hypertension: a randomized, double-blind, placebo-controlled trial. [2021]The purpose of this study was to assess the efficacy and safety of beraprost sodium, an orally active prostacyclin analogue, in New York Heart Association (NYHA) functional class II and III patients with pulmonary arterial hypertension (PAH).
Newly or switching effect of a selective EP2 agonist on intraocular pressure in Japanese patients with open-angle glaucoma. [2022]To evaluate omidenepag isopropyl (OMDI) for its efficacy in intraocular pressure control (IOP) and adverse reactions following administrations in Japanese patients with open-angle glaucoma (OAG) over a 3-month period.
Prolonged effectiveness of bepotastine besilate ophthalmic solution for the treatment of ocular symptoms of allergic conjunctivitis. [2017]This clinical trial evaluated the safety and effectiveness of bepotastine besilate ophthalmic solutions 1.0% and 1.5% compared with placebo for the treatment of ocular itching and conjunctival hyperemia (redness) using the conjunctival allergen challenge (CAC) model of allergic conjunctivitis when dosed 16 h before a CAC test.
Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH. [2023]Somapacitan is a long-acting GH derivative for treatment of GH deficiency (GHD).
Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan. [2021]Somapacitan is a long-acting growth hormone (GH) in development for once-weekly treatment of GH deficiency (GHD). Optimal monitoring of insulin-like growth factor-I (IGF-I) levels must account for weekly IGF-I fluctuations following somapacitan administration.
Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials. [2021]Somapacitan is a long-acting growth hormone (GH) derivative being developed for once-weekly dosing in patients with GH deficiency (GHD). Our objective was to evaluate the impact of kidney or hepatic impairment on somapacitan exposure in adults.