NCT03075644|CompletedPhase 3Results

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

A Multicentre, Randomised, Open-labelled, Parallel-group, Activecontrolled 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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN8640-4244U1111-1181-1618JapicCTI-173534

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredMar 2017

StartedMar 2017

CompletionOct 2018

Brief Summary

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.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Mar 2017

Geographic Reach

1 country

12 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

1.6 years study duration

First Submitted

Initial submission to the registry

February 28, 2017

Completed

3 days until next milestone

Study Start

First participant enrolled

March 3, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 4, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2018

Completed

2 years until next milestone

Results Posted

Study results publicly available

October 6, 2020

Completed

Last Updated

November 23, 2020

Status Verified

November 1, 2020

Enrollment Period

1.6 years

First QC Date

February 28, 2017

Results QC Date

September 11, 2020

Last Update Submit

November 3, 2020

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency

Outcome Measures

Primary Outcomes (1)

Incidence of Adverse Events, Including Injection Site Reactions
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment. Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented.
Weeks 0-53

Secondary Outcomes (28)

Change in Cross-sectional Total Adipose Tissue Compartments
Week 0, week 52
Change in Subcutaneous Adipose Tissue Compartments
Week 0, week 52
Change in Intra-abdominal or Visceral Adipose Tissue Compartments
Week 0, week 52
Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores
Week 0, week 52
Change in Physical Examination
Week 0, week 52
+23 more secondary outcomes

Study Arms (2)

Somapacitan

EXPERIMENTAL

Drug: somapacitan

Norditropin

ACTIVE COMPARATOR

Drug: Norditropin

Interventions

somapacitanDRUG

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

Somapacitan

NorditropinDRUG

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

Norditropin

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.