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Growth Hormone

Weekly vs Daily Growth Hormone for Growth Hormone Deficiency

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

Cohort I: Boys must have Tanner stage 1 for pubic hair and testis volume below 4 ml, age at least 2 years and 26 weeks and below or equal to 10.0 years at screening. Girls must have Tanner stage 1 for breast development and pubic hair, age at least 2 years and 26 weeks and below or equal to 9.0 years at screening. Confirmed diagnosis of GHD within 12 months prior to screening as determined by two different GH stimulation tests, defined as a peak GH level of below or equal to 7.0 ng/ml. No prior exposure to GH therapy and/or IGF-I treatment. Height of at least 2.0 standard deviations below the mean height for chronological age (CA) and gender. Annualized height velocity (HV) below the 25th percentile for CA and gender or below -0.7 SD score for CA and sex over a time span of minimum 6 months and maximum 18 months

Below 2 years and 26 weeks and a minimum weight of 5 kg at screening.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 26-52

Awards & highlights

No Placebo-Only Group

Summary

This trial is conducted to study the effectiveness and safety of a once-weekly hormone treatment compared to the daily growth hormone treatment in growth hormone naïve children before puberty. The trial has several phases and will follow participants for a long period of time.

Who is the study for?

This trial is for pre-pubertal children with growth hormone deficiency who have never been treated with growth hormones. They must be significantly shorter than average for their age and gender, and diagnosed within the last year through specific tests. Children under 2 years and 26 weeks must weigh at least 5 kg. Those with certain genetic conditions, bone or spinal abnormalities, or a history of cancer are not eligible.

What is being tested?

The study compares the effectiveness and safety of a once-weekly injection of Somapacitan (NNC0195-0092) to daily injections of Norditropin® FlexPro® in children who haven't received growth hormone treatment before. The trial includes several phases over multiple years to assess long-term effects.

What are the potential side effects?

Possible side effects may include reactions at the injection site, headaches, muscle or joint pain, swelling or fluid retention, development of antibodies against the medication which might reduce its effectiveness, and rare but serious complications like increased pressure in the brain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Boys must be between 2.5 and 10 years old and show early signs of puberty. Girls must be between 2.5 and 9 years old and also show early signs of puberty. They must have been diagnosed with growth hormone deficiency within the last 12 months, be shorter than most kids their age, and have a slow growth rate. They should not have received growth hormone or IGF-I treatment before.

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I am younger than 2 years and 6 months and weigh at least 5 kg.

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I have never been treated with GH or IGF-I therapies.

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I am a child with growth hormone deficiency and have open growth plates.

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I am a boy under 10 years old with early puberty signs.

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I am a girl aged 2.5 to 9 years, with early puberty signs.

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I am under 2.5 years old, weigh at least 5 kg, have GHD without prior GH or IGF-I treatment, and my IGF-1 SDS is below -1.0.

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My growth hormone levels are low, as shown by an IGF-1 SDS score below -1.0.

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I have never been treated with growth hormone or IGF-I.

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I am significantly shorter than average for my age and gender.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 26-52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 26-52

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26-52 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cohort I: Height velocity (HV) during the first 26 weeks of treatment, measured as standing height with stadiometer

Cohort II and III: Incidence of adverse events, including injection site reactions, in children with GHD

Secondary study objectives

Bone age

Change in HV (height velocity) SDS

Change in height standard deviation score (SDS)

+10 more

Side effects data

From 2018 Phase 3 trial • 62 Patients • NCT03075644

48%

Nasopharyngitis

Headache

Arthralgia

Influenza

Gingivitis

Rhinitis

Hypoaesthesia

Back pain

Inguinal hernia

Pharyngitis

Large intestine polyp

Rhinitis allergic

Respiratory tract infection

Chest pain

Oropharyngeal pain

Gastroenteritis

Head injury

100%

80%

60%

40%

20%

Study treatment Arm

Somapacitan

Norditropin®

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Blinded NNC0195-0092 (somapacitan) (0.16 mg/kg/week)Experimental Treatment1 Intervention

Participants receive the same dose (0.16 mg/kg/week) of NNC0195-0092 (somapacitan) during all 4 trial periods.

Group II: Blinded NNC0195-0092 (somapacitan) (0.08 mg/kg/week)Experimental Treatment1 Intervention

Participants receive NNC0195-0092 (somapacitan) (0.08 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods.

Group III: Blinded NNC0195-0092 (somapacitan) (0.04 mg/kg/week)Experimental Treatment1 Intervention

Participants receive NNC0195-0092 (somapacitan) (0.04 mg/kg/week) during the main trial and the extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the safety extension and the long-term safety extension periods.

Group IV: Open labelled daily Norditropin® (0.034 mg/kg/day)Active Control2 Interventions

Participants receive Norditropin during the main trial, the extension period and the safety extension period and thereafter NNC0195-0092 (somapacitan) (0.16 mg/kg/week) during the long-term safety extension periods.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

somapacitan

2017

Completed Phase 3

~860

0 / 10Eligibility criteria met