Overview

This trial is active, not recruiting.

Conditions growth hormone disorder, adult growth hormone deficiency
Treatments nnc0195-0092, somatropin, placebo
Phase phase 3
Sponsor Novo Nordisk A/S
Start date October 2014
End date May 2018
Trial size 280 participants
Trial identifier NCT02229851, 2013-002892-16, JapicCTI-152767, NN8640-4054, U1111-1145-0211

Summary

This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly dosing of NNC0195-0092 compared to placebo and once-daily dosing of somatropin (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone deficiency.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
nnc0195-0092
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.
(Active Comparator)
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.
(Placebo Comparator)
placebo
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Switch to NNC0195-0092 treatment in the extension period.

Primary Outcomes

Measure
Change in truncal fat percentage
time frame: Baseline, week 34

Secondary Outcomes

Measure
Change in truncal fat mass (kg)
time frame: Baseline, week 34
Change in truncal lean body mass (kg)
time frame: Baseline, week 34
Incidence of adverse events, including injection site reactions
time frame: Up to week 35
Incidence of adverse events, including injection site reactions
time frame: Up to week 88
Occurrence of anti-NNC0195-0092 antibodies
time frame: Up to week 35
Occurrence of anti-NNC0195-0092 antibodies
time frame: Up to week 88

Eligibility Criteria

Male or female participants from 23 years up to 79 years old.

Inclusion Criteria: - 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): - a. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L) - b. 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) - c. 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) Exclusion Criteria: - Active malignant disease or history of malignancy. Exceptions to this exclusion criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of squamous cell or basal cell carcinoma of the skin - 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

Additional Information

Official title 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 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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Novo Nordisk A/S.