Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

Phase 2

Completed

• Conditions: Growth Hormone Disorder; Adult Growth Hormone Deficiency
• Interventions: Drug: NNC126-0083; Drug: placebo

• Registration Number: NCT00715689
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-14
• Study First Submitted QC: 2008-07-14
• Study First Posted: 2008-07-15
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
• Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
• GH replacement therapy for more than 3 months
• Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive

Exclusion Criteria

• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
• Malignant disease
• Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
• Heart insufficiency, NYHA class greater than 2
• Subjects with diabetes with an HbA1C above 8.0%
• Diabetic receiving insulin treatment
• Stable pituitary replacement therapy for less than 3 months
• Impaired liver function
• Impaired kidney function

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	placebo	-
D	placebo	-
C	NNC126-0083	-
A	placebo	-
C	placebo	-
A	NNC126-0083	-
B	NNC126-0083	-
D	NNC126-0083	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability (adverse events, local tolerability, physical examination)	0 to 10 days after third dosing, (day 15-25 after first dose)

Secondary Outcome Measures

Name	Time	Method
Cmax, maximum concentration of IGF-I	after trial product administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇩🇰 Århus C, Denmark