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Growth Hormone

Somapacitan vs. Norditropin® for Small for Gestational Age (SGA) Children

Phase 2
Waitlist Available
Research Sponsored by Novo Nordisk A/S
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pre-pubertal boys aged between 2.5 and 11.0 years at screening with testes volume below 4 ml
Pre-pubertal girls aged between 2.5 and 10.0 years at screening with Tanner stage 1 for breast development, born small for gestational age, impaired height, impaired height velocity, and no prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from screening (visit 1) to week 26
Awards & highlights

Study Summary

This trial is comparing two medicines to see if they are effective in treating children who were born small and stayed small. One medicine is given once a week, and the other is given once a day. The trial will last for four years, and participants will have nine clinic visits.

Who is the study for?
This trial is for pre-pubertal boys aged 2.5-11 years and girls aged 2.5-10 years who were born small, have stayed small, and haven't had growth hormone or IGF-I treatment. Kids with hormonal deficiencies, significant health issues affecting growth, recent steroid treatments, high-dose inhaled steroids, or other growth-affecting drugs can't join.Check my eligibility
What is being tested?
The study compares somapacitan (a new medicine given weekly) to Norditropin® (an existing daily treatment) in children born small for gestational age. It's a randomized trial where both doctors and participants know which treatment is received over the course of one year with follow-up.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site, headaches, muscle or joint pain, and possible development of antibodies to the medication that could reduce its effectiveness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a boy aged 2.5 to 11 years with small testes.
Select...
I am a girl aged 2.5-10, born small for my age, with slow growth and no hormone treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from screening (visit 1) to week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening (visit 1) to week 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Height velocity
Secondary outcome measures
Bone and Bones
Change in fasting plasma glucose
Change in glycated haemoglobin (HbA1c)
+5 more

Side effects data

From 2018 Phase 3 trial • 62 Patients • NCT03075644
48%
Nasopharyngitis
9%
Headache
7%
Influenza
7%
Arthralgia
7%
Gingivitis
7%
Rhinitis
4%
Back pain
4%
Hypoaesthesia
2%
Inguinal hernia
2%
Respiratory tract infection
2%
Large intestine polyp
2%
Rhinitis allergic
2%
Pharyngitis
2%
Chest pain
2%
Oropharyngeal pain
2%
Gastroenteritis
2%
Head injury
100%
80%
60%
40%
20%
0%
Study treatment Arm
Somapacitan
Norditropin®

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Group I: 0.24 mg/kg somapacitanExperimental Treatment1 Intervention
Same treatment in main period (13 weeks) and extension period (39 weeks)
Group II: 0.20 mg/kg somapacitanExperimental Treatment1 Intervention
Same treatment in main period (13 weeks) and extension period (39 weeks)
Group III: 0.16 mg/kg somapacitanExperimental Treatment1 Intervention
Same treatment in main period (13 weeks) and extension period (39 weeks)
Group IV: 0.067 mg/kg Norditropin®Active Control1 Intervention
Same treatment in main period (13 weeks) and extension period (39 weeks)
Group V: 0.035 mg/kg Norditropin®Active Control1 Intervention
Same treatment in main period (13 weeks) and extension period (39 weeks)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
somapacitan
2017
Completed Phase 3
~780

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,503 Previous Clinical Trials
2,385,752 Total Patients Enrolled
Clinical Reporting Anchor and Disclosure 1452Study DirectorNovo Nordisk A/S
10 Previous Clinical Trials
2,115 Total Patients Enrolled

Media Library

Norditropin® (Growth Hormone) Clinical Trial Eligibility Overview. Trial Name: NCT03878446 — Phase 2
Small for Gestational Age (SGA) Research Study Groups: 0.067 mg/kg Norditropin®, 0.16 mg/kg somapacitan, 0.035 mg/kg Norditropin®, 0.24 mg/kg somapacitan, 0.20 mg/kg somapacitan
Small for Gestational Age (SGA) Clinical Trial 2023: Norditropin® Highlights & Side Effects. Trial Name: NCT03878446 — Phase 2
Norditropin® (Growth Hormone) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03878446 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is somapacitan typically used to heal?

"Somapacitan has clinical applications in treating general surgery patients, those with short stature, and those with open epiphyses."

Answered by AI

What is the largest number of people who can be included in this research project?

"Unfortunately, this study isn't looking for any more patients at the moment. The listing was first put up on July 4th, 2019, and the most recent update was on September 15th, 2022. However, there are 12 other trials for patients with dwarfism that are recruiting and 35 for somapacitan."

Answered by AI

Has somapacitan been cleared for public consumption in the United States?

"Somapacitan has not been proven effective in any clinical trials, however it has showed some signs of being safe. For this reason, it received a score of 2."

Answered by AI

What are the other scientific investigations into somapacitan's effects?

"Somapacitan, a novel drug, is being investigated in 35 clinical trials, 14 of which are in Phase 3. Currently, 645 medical centres across the globe are running studies on somapacitan, with several of these locations in Philadelphia, Pennsylvania."

Answered by AI

Would I be able to join this scientific research if I wanted to?

"As this is a clinical trial investigating a potential treatment for dwarfism, patients must have the condition to be eligible. In addition, all participants must be aged 2-11. A total of 62 individuals are being recruited for the trial."

Answered by AI

Does the age limit for this test allow for people in their seventies to participate?

"Children aged 2-11 may be eligible for this study, based on the inclusion criteria."

Answered by AI

How many different hospitals are currently conducting this trial?

"Currently, there are 14 sites conducting this trial with more locations in New york, Oklahoma City and Minneapolis. If you're interested in enrolling, try to select a site that is close to your location to reduce travel times."

Answered by AI
~11 spots leftby Mar 2025