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A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

NCT ID: NCT03075644

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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-03

Study Completion Date

2018-10-04

Brief Summary

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This trial is conducted in Asia. The aim of this trial is to evaluate the safety of once weekly dosing of somapacitan (NNC0195-0092) and daily Norditropin® FlexPro® for 52 weeks in previously human growth hormone treated Japanese 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

NONE

Study Groups

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Somapacitan

Group Type EXPERIMENTAL

somapacitan

Intervention Type DRUG

Once weekly subcutaneous injections (s.c., under the skin)

Norditropin

Group Type ACTIVE_COMPARATOR

Norditropin

Intervention Type DRUG

Daily subcutaneous injections (s.c., under the skin)

Interventions

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somapacitan

Once weekly subcutaneous injections (s.c., under the skin)

Intervention Type DRUG

Norditropin

Daily subcutaneous injections (s.c., under the skin)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male or female of at least 18 years of age and not more than 79 years of age at the time of signing informed consent - GHD diagnosed for at least 6 months (defined as 180 days) prior to screening - Treatment with hGH for at least 6 consecutive months (defined as 180 days) at screening - 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 Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:1/ Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision 2/ 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 medical records - For subjects with surgical removal or debulking of pituitary adenoma or other benign intracranial tumour within the last 5 years:Evidence of growth of pituitary adenoma or other benign intracranial tumour within the last 12 months (defined as below or equal to 365 days) before randomisation. Absence of growth must be documented by two post-surgery magnetic resonance imaging (MRI) scans or CT scans. The most recent MRI or CT scan must be performed below or equal to 9 months (defined as below or equal to 270 days) prior to randomisation
Minimum Eligible Age

18 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

Locations

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Novo Nordisk Investigational Site

Bunkyo-ku, Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Chiba-shi, Chiba, , Japan

Site Status

Novo Nordisk Investigational Site

Fukuoka, , Japan

Site Status

Novo Nordisk Investigational Site

Kagoshima, , Japan

Site Status

Novo Nordisk Investigational Site

Kobe, Hyogo, , Japan

Site Status

Novo Nordisk Investigational Site

Kyoto-shi Kyoto, , Japan

Site Status

Novo Nordisk Investigational Site

Okayama, Okayama, , Japan

Site Status

Novo Nordisk Investigational Site

Osaka, , Japan

Site Status

Novo Nordisk Investigational Site

Sagamihara-shi, Kanagawa, , Japan

Site Status

Novo Nordisk Investigational Site

Tokyo, , Japan

Site Status

Novo Nordisk Investigational Site

Yamagata-shi, Yamagata, , Japan

Site Status

Novo Nordisk Investigational Site

Yokohama, Kanagawa, , Japan

Site Status

Countries

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Japan

References

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Otsuka F, Takahashi Y, Tahara S, Ogawa Y, Hojby Rasmussen M, Takano K. Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone. Clin Endocrinol (Oxf). 2020 Nov;93(5):620-628. doi: 10.1111/cen.14273. Epub 2020 Aug 14.

Reference Type RESULT
PMID: 32603494 (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 and Statistical Analysis Plan

View Document

Other Identifiers

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U1111-1181-1618

Identifier Type: OTHER

Identifier Source: secondary_id

JapicCTI-173534

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN8640-4244

Identifier Type: -

Identifier Source: org_study_id