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

NCT ID: NCT02229851

Last Updated: 2020-11-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2018-05-07

Brief Summary

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This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.

Detailed Description

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Conditions

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Growth Hormone Disorder Adult Growth Hormone Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NNC0195-0092 (somapacitan)

Group Type EXPERIMENTAL

somapacitan

Intervention Type DRUG

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.

Daily hGH

Group Type ACTIVE_COMPARATOR

somatropin

Intervention Type DRUG

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.

Placebo

Switch to NNC0195-0092 (somapacitan) treatment in the extension period.

Group Type PLACEBO_COMPARATOR

somapacitan

Intervention Type DRUG

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.

placebo

Intervention Type DRUG

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

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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NNC0195-0092

Eligibility Criteria

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Inclusion Criteria

* Male or female of at least 23 years of age and not more than 79 years of age at the time of signing informed consent
* Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone (GH) secretagogues for at least 180 days prior to randomisation with any registered or investigational hGH or GH secretagogue product (if only used in connection with stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be included)
* If applicable, hormone replacement therapies for any other hormone deficiencies, adequate and stable for at least 90 days prior to randomisation as judged by the investigator
* FOR ALL COUNTRIES EXCEPT JAPAN:

Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the following criterion and documentation of test results must be available before randomisation (either from subjects' file or new test):

1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m\^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI 25-30 kg/m\^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m\^2, a peak GH less than 4 ng/mL (4 mcg/L)
3. Three or more pituitary hormone deficiencies and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth hormone deficiency (AGHD) need to satisfy at least one of the following criteria, subjects with a history of childhood GHD need to satisfy at least 2 of the following criteria):

a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)

Exclusion Criteria

* Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin
* Subjects with GHD attributed to treatment of intracranial malignant tumours or leukaemia, provided that a recurrence-free survival period of at least 5 years is documented in the subject's file
Minimum Eligible Age

23 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor and Disclosure' (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Birmingham, Alabama, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Aurora, Colorado, United States

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Atlanta, Georgia, United States

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Roswell, Georgia, United States

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Topeka, Kansas, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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East Lansing, Michigan, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Omaha, Nebraska, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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New York, New York, United States

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Cleveland, Ohio, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Shavano Park, Texas, United States

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Salt Lake City, Utah, United States

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Federal Way, Washington, United States

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Seattle, Washington, United States

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Blacktown, New South Wales, Australia

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Coffs Harbour, New South Wales, Australia

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Darlinghurst, New South Wales, Australia

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St Leonards, New South Wales, Australia

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Woolloongabba, Queensland, Australia

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Box Hill, Victoria, Australia

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Parkville, Victoria, Australia

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Nedlands, Western Australia, Australia

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São Paulo, São Paulo, Brazil

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Aachen, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Frankfurt, , Germany

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Oldenburg, , Germany

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Hyderabad, Andhra Pradesh, India

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Bangalore, Karnataka, India

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Kochi, Kerala, India

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Mumbai, Maharashtra, India

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New Dehli, New Delhi, India

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Chandigarh, Punjab, India

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Hyderabad, Telangana, India

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Kolkata, West Bengal, India

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Bunkyo-ku, Tokyo, , Japan

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Chiba-shi, Chiba, , Japan

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Fukuoka-shi, Fukuoka, , Japan

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Hamamatsu-shi, Shizuoka, , Japan

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Itabashi-ku, Tokyo, , Japan

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Kagoshima, , Japan

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Kyoto-shi Kyoto, , Japan

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Minato-ku, Tokyo, , Japan

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Okayama, Okayama, , Japan

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Sagamihara-shi, Kanagawa, , Japan

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Sapporo, Hokkaido, , Japan

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Sappro-shi, Hokkaido, , Japan

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Tokyo, , Japan

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Yamagata-shi, Yamagata, , Japan

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Yokohama, Kanagawa, , Japan

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Riga, , Latvia

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Kaunas, , Lithuania

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Vilnius, , Lithuania

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Kuching, , Malaysia

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Pulau Pinang, , Malaysia

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Putrajaya, , Malaysia

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Oslo, , Norway

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Bialystok, , Poland

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Gdansk, , Poland

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Krakow, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Wroclaw, , Poland

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Cluj-Napoca, Cluj, Romania

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Târgu Mureş, Mureș County, Romania

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Bucharest, , Romania

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Iași, , Romania

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Sibiu, , Romania

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Timișoara, , Romania

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Kazan', , Russia

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Krasnoyarsk, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Novosibirsk, , Russia

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Tomsk, , Russia

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Johannesburg, Gauteng, South Africa

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Johannesburg, Gauteng, South Africa

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Pretoria, Gauteng, South Africa

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Tygerberg, Western Cape, South Africa

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Gothenburg, , Sweden

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Stockholm, , Sweden

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Uppsala, , Sweden

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Adana, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Kiev, , Ukraine

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Kyiv, , Ukraine

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Birmingham, , United Kingdom

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Coventry, , United Kingdom

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Exeter, , United Kingdom

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Hull, , United Kingdom

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Leeds, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Manchester, , United Kingdom

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Countries

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United States Australia Brazil Germany India Israel Japan Latvia Lithuania Malaysia Norway Poland Romania Russia South Africa Sweden Turkey (Türkiye) Ukraine United Kingdom

References

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Johannsson G, Gordon MB, Hojby Rasmussen M, Hakonsson IH, Karges W, Svaerke C, Tahara S, Takano K, Biller BMK. Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1358-76. doi: 10.1210/clinem/dgaa049.

Reference Type RESULT
PMID: 32022863 (View on PubMed)

Otsuka F, Rasmussen MH, Endo T, Svaerke C, Tahara S, Johannsson G. Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial. Front Endocrinol (Lausanne). 2025 Feb 7;16:1534891. doi: 10.3389/fendo.2025.1534891. eCollection 2025.

Reference Type DERIVED
PMID: 39991735 (View on PubMed)

Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.

Reference Type DERIVED
PMID: 36380045 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2013-002892-16

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1145-0211

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-152767

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN8640-4054

Identifier Type: -

Identifier Source: org_study_id