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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.

NCT02229851 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2020-11-23

Study results available
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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.

Conditions

  • Growth Hormone Disorder
  • Adult 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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Reporting Anchor and Disclosure' (1452) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
23 Years
Max Age
79 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-04-21
Completion
2018-05-07
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02229851 on ClinicalTrials.gov