Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

PHASE3CompletedINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

October 31, 2014

Primary Completion Date

April 21, 2017

Study Completion Date

May 7, 2018

Conditions
Growth Hormone DisorderAdult Growth Hormone Deficiency
Interventions
DRUG

somapacitan

Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.

DRUG

somatropin

Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.

DRUG

placebo

Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.

Trial Locations (117)

2010

Novo Nordisk Investigational Site, Darlinghurst

2013

Novo Nordisk Investigational Site, Johannesburg

2065

Novo Nordisk Investigational Site, St Leonards

2148

Novo Nordisk Investigational Site, Blacktown

2193

Novo Nordisk Investigational Site, Johannesburg

2450

Novo Nordisk Investigational Site, Coffs Harbour

3052

Novo Nordisk Investigational Site, Parkville

3128

Novo Nordisk Investigational Site, Box Hill

4102

Novo Nordisk Investigational Site, Woolloongabba

6009

Novo Nordisk Investigational Site, Nedlands

7505

Novo Nordisk Investigational Site, Tygerberg

10032

Novo Nordisk Investigational Site, New York

10117

Novo Nordisk Investigational Site, Berlin

10990

Novo Nordisk Investigational Site, Pulau Pinang

13352

Novo Nordisk Investigational Site, Berlin

15212

Novo Nordisk Investigational Site, Pittsburgh

19104

Novo Nordisk Investigational Site, Philadelphia

19107

Novo Nordisk Investigational Site, Philadelphia

21205

Novo Nordisk Investigational Site, Baltimore

26122

Novo Nordisk Investigational Site, Oldenburg

30076

Novo Nordisk Investigational Site, Roswell

30318

Novo Nordisk Investigational Site, Atlanta

34098

Novo Nordisk Investigational Site, Istanbul

34390

Novo Nordisk Investigational Site, Istanbul

35100

Novo Nordisk Investigational Site, Izmir

35233

Novo Nordisk Investigational Site, Birmingham

41380

Novo Nordisk Investigational Site, Kocaeli

44195

Novo Nordisk Investigational Site, Cleveland

48824

Novo Nordisk Investigational Site, East Lansing

49100

Novo Nordisk Investigational Site, Petah Tikva

50009

Novo Nordisk Investigational Site, Kaunas

52074

Novo Nordisk Investigational Site, Aachen

52621

Novo Nordisk Investigational Site, Tel Litwinsky

60596

Novo Nordisk Investigational Site, Frankfurt

62250

Novo Nordisk Investigational Site, Putrajaya

63110

Novo Nordisk Investigational Site, St Louis

64239

Novo Nordisk Investigational Site, Tel Aviv

66606

Novo Nordisk Investigational Site, Topeka

68105

Novo Nordisk Investigational Site, Omaha

75093

Novo Nordisk Investigational Site, Plano

77030

Novo Nordisk Investigational Site, Houston

78229

Novo Nordisk Investigational Site, San Antonio

78231

Novo Nordisk Investigational Site, Shavano Park

79935

Novo Nordisk Investigational Site, El Paso

80045

Novo Nordisk Investigational Site, Aurora

84103

Novo Nordisk Investigational Site, Salt Lake City

89128

Novo Nordisk Investigational Site, Las Vegas

89511

Novo Nordisk Investigational Site, Reno

90033

Novo Nordisk Investigational Site, Los Angeles

90095

Novo Nordisk Investigational Site, Los Angeles

93586

Novo Nordisk Investigational Site, Kuching

97239

Novo Nordisk Investigational Site, Portland

98003

Novo Nordisk Investigational Site, Federal Way

110029

Novo Nordisk Investigational Site, New Dehli

117036

Novo Nordisk Investigational Site, Moscow

119435

Novo Nordisk Investigational Site, Moscow

160012

Novo Nordisk Investigational Site, Chandigarh

300736

Novo Nordisk Investigational Site, Timișoara

400008

Novo Nordisk Investigational Site, Mumbai

400349

Novo Nordisk Investigational Site, Cluj-Napoca

420061

Novo Nordisk Investigational Site, Kazan'

500033

Novo Nordisk Investigational Site, Hyderabad

500034

Novo Nordisk Investigational Site, Hyderabad

540142

Novo Nordisk Investigational Site, Târgu Mureş

550166

Novo Nordisk Investigational Site, Sibiu

560034

Novo Nordisk Investigational Site, Bangalore

630099

Novo Nordisk Investigational Site, Novosibirsk

634050

Novo Nordisk Investigational Site, Tomsk

660022

Novo Nordisk Investigational Site, Krasnoyarsk

682041

Novo Nordisk Investigational Site, Kochi

700032

Novo Nordisk Investigational Site, Kolkata

700111

Novo Nordisk Investigational Site, Iași

02114

Novo Nordisk Investigational Site, Boston

68198-4120

Novo Nordisk Investigational Site, Omaha

98122-5789

Novo Nordisk Investigational Site, Seattle

01228-000

Novo Nordisk Investigational Site, São Paulo

113-8603

Novo Nordisk Investigational Site, Bunkyo-ku, Tokyo

260-8677

Novo Nordisk Investigational Site, Chiba-shi, Chiba

812-8582

Novo Nordisk Investigational Site, Fukuoka-shi, Fukuoka

431-3192

Novo Nordisk Investigational Site, Hamamatsu-shi, Shizuoka

173-8606

Novo Nordisk Investigational Site, Itabashi-ku, Tokyo

890-8520

Novo Nordisk Investigational Site, Kagoshima

612-8555

Novo Nordisk Investigational Site, Kyoto-shi Kyoto

105-8470

Novo Nordisk Investigational Site, Minato-ku, Tokyo

700-8558

Novo Nordisk Investigational Site, Okayama, Okayama

252-0375

Novo Nordisk Investigational Site, Sagamihara-shi, Kanagawa

060-8648

Novo Nordisk Investigational Site, Sapporo, Hokkaido

060 8648

Novo Nordisk Investigational Site, Sappro-shi, Hokkaido

134-0088

Novo Nordisk Investigational Site, Tokyo

990-9585

Novo Nordisk Investigational Site, Yamagata-shi, Yamagata

222-0036

Novo Nordisk Investigational Site, Yokohama, Kanagawa

LV-1002

Novo Nordisk Investigational Site, Riga

08661

Novo Nordisk Investigational Site, Vilnius

0027

Novo Nordisk Investigational Site, Oslo

15-879

Novo Nordisk Investigational Site, Bialystok

80-952

Novo Nordisk Investigational Site, Gdansk

31-455

Novo Nordisk Investigational Site, Krakow

02-507

Novo Nordisk Investigational Site, Warsaw

04-141

Novo Nordisk Investigational Site, Warsaw

50-311

Novo Nordisk Investigational Site, Wroclaw

50-367

Novo Nordisk Investigational Site, Wroclaw

011863

Novo Nordisk Investigational Site, Bucharest

0044

Novo Nordisk Investigational Site, Pretoria

413 45

Novo Nordisk Investigational Site, Gothenburg

171 76

Novo Nordisk Investigational Site, Stockholm

751 85

Novo Nordisk Investigational Site, Uppsala

01130

Novo Nordisk Investigational Site, Adana

01021

Novo Nordisk Investigational Site, Kiev

04114

Novo Nordisk Investigational Site, Kyiv

B15 2TH

Novo Nordisk Investigational Site, Birmingham

CV2 2DX

Novo Nordisk Investigational Site, Coventry

EX2 5DW

Novo Nordisk Investigational Site, Exeter

HU3 2RW

Novo Nordisk Investigational Site, Hull

LS9 7TF

Novo Nordisk Investigational Site, Leeds

EC1A 7BE

Novo Nordisk Investigational Site, London

SE5 9RS

Novo Nordisk Investigational Site, London

M20 4BX

Novo Nordisk Investigational Site, Manchester

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novo Nordisk A/S

INDUSTRY

NCT02229851 - Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency. | Biotech Hunter | Biotech Hunter