← Back to Search

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

Be younger than 18 years old

Must not have

Prior history or presence of malignancy including intracranial tumors

Children requiring inhaled glucocorticoid therapy at a dose of greater than 400 μg/day of inhaled budesonide or equivalents for longer than 4 consecutive weeks within the last 12 months prior to screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (week 0); week 52

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had cancer before, including brain tumors.

Select...

My child has been on high-dose asthma medication for over a month in the past year.

Select...

I haven't taken steroids for inflammation for more than 2 weeks in the last 3 months.

Select...

I have been diagnosed with ADHD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (week 0); week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline (week 0); week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (week 0); week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Height Velocity

Secondary study objectives

Change in Fasting Plasma Glucose

Change in Glycated Haemoglobin (HbA1c)

Change in Height Standard Deviation Score (HSDS)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Group I: Somapacitan 0.24 mg/kg/weekExperimental Treatment1 Intervention

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.

Group II: Somapacitan 0.20 mg/kg/weekExperimental Treatment1 Intervention

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.

Group III: Somapacitan 0.16 mg/kg/weekExperimental Treatment1 Intervention

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.

Group IV: Norditropin® 0.035 mg/kg/dayActive Control1 Intervention

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.

Group V: Norditropin® 0.067 mg/kg/dayActive Control1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Somapacitan

2017

Completed Phase 1

~80

0 / 5Eligibility criteria met