NCT02229851|CompletedPhase 3ResultsFDA Drug

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

REAL 1

A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period

Novo Nordisk A/S ClinicalTrials.gov

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4 other identifiers

NN8640-40542013-002892-16U1111-1145-0211JapicCTI-152767

Study Type

interventional

Target

301

Locations

19 countries

Sites

117

Timeline

RegisteredSep 2014

StartedOct 2014

CompletionMay 2018

Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

301

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Oct 2014

Typical duration for phase_3

Geographic Reach

19 countries

117 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

First Submitted

Initial submission to the registry

August 26, 2014

Completed

8 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed

2 months until next milestone

Study Start

First participant enrolled

October 31, 2014

Completed

2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 21, 2017

Completed

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2018

Completed

2.2 years until next milestone

Results Posted

Study results publicly available

July 7, 2020

Completed

Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

2.5 years

First QC Date

August 26, 2014

Results QC Date

April 3, 2020

Last Update Submit

November 3, 2020

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

Change in Truncal Fat Percentage (Week 34)
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Week -3, week 34

Secondary Outcomes (119)

Change in Truncal Fat Percentage (Week 87)
week -3, week 87
Change in Truncal Fat Mass (Week 34)
Week -3, week 34
Change in Truncal Fat Mass (Week 87)
week -3, week 87
Change in Truncal Lean Body Mass (Week 34)
Week -3, week 34
Change in Truncal Lean Body Mass (Week 87)
week -3, week 87
+114 more secondary outcomes

Study Arms (3)

NNC0195-0092 (somapacitan)

EXPERIMENTAL

Drug: somapacitan

Daily hGH

ACTIVE COMPARATOR

Drug: somatropin

Placebo

PLACEBO COMPARATOR

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

Drug: somapacitanDrug: placebo

Interventions

somapacitanDRUG

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.

Also known as: NNC0195-0092

NNC0195-0092 (somapacitan)Placebo

somatropinDRUG

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.

Daily hGH

placeboDRUG

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

Placebo

Eligibility Criteria

Age23 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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):
Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
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)
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)

You may not qualify if:

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

Contact the study team to confirm eligibility.