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A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

Primary Purpose

Short Stature Children Born Small for Gestational Age (SGA)

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
somapacitan
Norditropin®
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Short Stature Children Born Small for Gestational Age (SGA)

Eligibility Criteria

2 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pre-pubertal children, boys:

    1. age between 2.5 and 11.0 years at screening.
    2. testes volume below 4 ml.

  • Pre-pubertal children, girls:

    1. age between 2.5 and 10.0 years at screening.
    2. Tanner stage 1 for breast development (no palpable glandular breast tissue).
  • Born small for gestational age (birth length and/or weight below -2 standard deviation scores) (according to national standards).
  • Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening.
  • Impaired height velocity defined as annualised height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening.
  • No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment.

Exclusion Criteria:

  • Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements.
  • Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise.
  • Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
  • 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.
  • Concomitant administration of other treatments that may have an effect on growth, e.g but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder.
  • Diagnosis of attention deficit hyperactivity disorder.
  • Prior history or presence of malignancy including intracranial tumours.

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

0.24 mg/kg somapacitan

0.20 mg/kg somapacitan

0.16 mg/kg somapacitan

0.035 mg/kg Norditropin®

0.067 mg/kg Norditropin®

Arm Description

Same treatment in main period (13 weeks) and extension period (39 weeks)

Same treatment in main period (13 weeks) and extension period (39 weeks)

Same treatment in main period (13 weeks) and extension period (39 weeks)

Same treatment in main period (13 weeks) and extension period (39 weeks)

Same treatment in main period (13 weeks) and extension period (39 weeks)

Outcomes

Primary Outcome Measures

Height velocity
cm/year

Secondary Outcome Measures

Change in bone age
years
Change in height standard deviation score (SDS)
-10 to +10
Change in height velocity SDS
-10 to +10
Change in fasting plasma glucose
mmol/l
Change in homeostatic model assessment (HOMA)
Percent
Change in glycated haemoglobin (HbA1c)
Percentage points
Change in insulin-like growth factor I (IGF-I) SDS
-10 to +10
Change in insulin-like growth factor binding protein 3 (IGFBP-3) SDS
-10 to +10

Full Information

First Posted
March 15, 2019
Last Updated
September 26, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT03878446
Brief Title
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
Official Title
A Dose-finding Trial Evaluating the Effect and Safety of Once-weekly Treatment of Somapacitan Compared to Daily Norditropin® in Children With Short Stature Born Small for Gestational Age With no Catch-up Growth by 2 Years of Age or Older
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 4, 2019 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
May 12, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe). Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 4 years. Participants will take either an injection once every week or once every day. Participants will have 9 clinic visits and will be in the study for 1 year. The follow-up period is at least 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Short Stature Children Born Small for Gestational Age (SGA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.24 mg/kg somapacitan
Arm Type
Experimental
Arm Description
Same treatment in main period (13 weeks) and extension period (39 weeks)
Arm Title
0.20 mg/kg somapacitan
Arm Type
Experimental
Arm Description
Same treatment in main period (13 weeks) and extension period (39 weeks)
Arm Title
0.16 mg/kg somapacitan
Arm Type
Experimental
Arm Description
Same treatment in main period (13 weeks) and extension period (39 weeks)
Arm Title
0.035 mg/kg Norditropin®
Arm Type
Active Comparator
Arm Description
Same treatment in main period (13 weeks) and extension period (39 weeks)
Arm Title
0.067 mg/kg Norditropin®
Arm Type
Active Comparator
Arm Description
Same treatment in main period (13 weeks) and extension period (39 weeks)
Intervention Type
Drug
Intervention Name(s)
somapacitan
Intervention Description
Somapacitan injected under the skin once a week for a total of 52 weeks
Intervention Type
Drug
Intervention Name(s)
Norditropin®
Intervention Description
Norditropin® injected under the skin once a day for a total of 52 weeks
Primary Outcome Measure Information:
Title
Height velocity
Description
cm/year
Time Frame
From baseline (week 0) to week 26
Secondary Outcome Measure Information:
Title
Change in bone age
Description
years
Time Frame
From baseline (week 0) to week 52
Title
Change in height standard deviation score (SDS)
Description
-10 to +10
Time Frame
From baseline (week 0) to week 26
Title
Change in height velocity SDS
Description
-10 to +10
Time Frame
From baseline (week 0) to week 26
Title
Change in fasting plasma glucose
Description
mmol/l
Time Frame
From screening (visit 1) to week 26
Title
Change in homeostatic model assessment (HOMA)
Description
Percent
Time Frame
From screening (visit 1) to week 26
Title
Change in glycated haemoglobin (HbA1c)
Description
Percentage points
Time Frame
From screening (visit 1) to week 26
Title
Change in insulin-like growth factor I (IGF-I) SDS
Description
-10 to +10
Time Frame
From screening (visit 1) to week 26
Title
Change in insulin-like growth factor binding protein 3 (IGFBP-3) SDS
Description
-10 to +10
Time Frame
From screening (visit 1) to week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pre-pubertal children, boys: age between 2.5 and 11.0 years at screening. testes volume below 4 ml. Pre-pubertal children, girls: age between 2.5 and 10.0 years at screening. Tanner stage 1 for breast development (no palpable glandular breast tissue). Born small for gestational age (birth length and/or weight below -2 standard deviation scores) (according to national standards). Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and gender at screening according to the standards of Centers for Disease Control and Prevention at screening. Impaired height velocity defined as annualized height velocity below the 50th percentile for chronological age and gender according to the standards of Prader calculated over a time span of minimum 6 months and maximum 18 months prior to screening. No prior exposure to growth hormone therapy or Insulin-like Growth Factor-I (IGF-I) treatment. Exclusion Criteria: Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with standing height measurements. Children with hormonal deficiencies including suspected or confirmed growth hormone deficiency according to local practise. Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening. 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. Concomitant administration of other treatments that may have an effect on growth, e.g but not limited to methylphenidate for treatment of attention deficit hyperactivity disorder. Diagnosis of attention deficit hyperactivity disorder. Prior history or presence of malignancy including intracranial tumours.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Reporting Anchor and Disclosure 1452
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Novo Nordisk Investigational Site
City
Algiers
ZIP/Postal Code
16000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Constantine
ZIP/Postal Code
25000
Country
Algeria
Facility Name
Novo Nordisk Investigational Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Salzburg
ZIP/Postal Code
A 5020
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
St. Poelten
ZIP/Postal Code
A 3100
Country
Austria
Facility Name
Novo Nordisk Investigational Site
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Novo Nordisk Investigational Site
City
Le Kremlin-bicetre
ZIP/Postal Code
94275
Country
France
Facility Name
Novo Nordisk Investigational Site
City
MARSEILLE Cédex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novo Nordisk Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Novo Nordisk Investigational Site
City
Kochi
State/Province
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Novo Nordisk Investigational Site
City
New Dehli
State/Province
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Novo Nordisk Investigational Site
City
Dublin
ZIP/Postal Code
D12 N512
Country
Ireland
Facility Name
Novo Nordisk Investigational Site
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Novo Nordisk Investigational Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Genova
ZIP/Postal Code
16147
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka-shi, Fukuoka
ZIP/Postal Code
813-0017
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Fukuyama-shi, Hiroshima
ZIP/Postal Code
721-8511
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Kobe-shi, Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Nara-shi, Nara
ZIP/Postal Code
630-8581
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Niigata-shi, Niigata
ZIP/Postal Code
951 8520
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Osaka
ZIP/Postal Code
594-1101
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Saitama-shi, Saitama
ZIP/Postal Code
330-8777
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
157 8535
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Novo Nordisk Investigational Site
City
Riga
ZIP/Postal Code
LV1004
Country
Latvia
Facility Name
Novo Nordisk Investigational Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Novo Nordisk Investigational Site
City
Szczecin
ZIP/Postal Code
71-252
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Facility Name
Novo Nordisk Investigational Site
City
Izhevsk
ZIP/Postal Code
426009
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Moscow
ZIP/Postal Code
119435
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Novosibirsk
ZIP/Postal Code
630048
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Saint-Petersburg
ZIP/Postal Code
191144
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Samara
ZIP/Postal Code
443079
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Tomsk
ZIP/Postal Code
634050
Country
Russian Federation
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Belgrade
ZIP/Postal Code
11070
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Nis
ZIP/Postal Code
18 000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Facility Name
Novo Nordisk Investigational Site
City
Esplugues Llobregat(Barcelona)
ZIP/Postal Code
08950
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Novo Nordisk Investigational Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
Novo Nordisk Investigational Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novo Nordisk Investigational Site
City
Kharkiv
ZIP/Postal Code
61000
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Novo Nordisk Investigational Site
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Novo Nordisk Investigational Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

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