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

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Adult Growth Hormone Deficiency; Growth Hormone Disorder

Treatments: Drug: NNC126-0083; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00715689

NN8630-1823

2008-001061-29 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 33 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 4 patient groups

A

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083

B

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083

C

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083

D

Experimental group

Treatment:

Drug: placebo

Drug: NNC126-0083

Drug: NNC126-0083

Drug: placebo

Drug: NNC126-0083

Drug: placebo

Drug: placebo

Drug: NNC126-0083