Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Novo Nordisk A/S301 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

301

Conditions

Growth Hormone Disorder Adult Growth Hormone Deficiency

Interventions

somapacitanDRUG

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.

somatropinDRUG

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.

placeboDRUG

Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.

Eligibility

Sex: ALLMin age: 23 YearsMax age: 79 Years

Medical Language ↔ Plain English

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): 1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L) 2. 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) 3. 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

Locations (117)

Outcomes

Primary Outcomes

Change in Truncal Fat Percentage (Week 34)

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time frame: Week -3, week 34

Secondary Outcomes

Change in Truncal Fat Percentage (Week 87)

Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time frame: week -3, week 87

Change in Truncal Fat Mass (Week 34)

Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time frame: Week -3, week 34

Change in Truncal Fat Mass (Week 87)

Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time frame: week -3, week 87

Change in Truncal Lean Body Mass (Week 34)

Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Time frame: Week -3, week 34

Change in Truncal Lean Body Mass (Week 87)

Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Time frame: week -3, week 87

Change in Total Fat Mass (Week 34)

Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).

Data from ClinicalTrials.gov

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