Current partner codePEPTIDESDE
NCT02229851·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

301

Locations

117

Results

Posted

Publications

3

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

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.

Timeline

From registration to results.

  1. First posted

    Sep 3, 2014

  2. Study start

    Oct 31, 2014

  3. Primary completion

    Apr 21, 2017

  4. Study completion

    May 7, 2018

  5. Results posted

    Jul 7, 2020

  6. Registry updated

    Nov 23, 2020

Outcomes

What the study measures.

Primary outcomes

Change in Truncal Fat Percentage (Week 34)

Time frame · Week -3, week 34

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

Secondary outcomes

Change in Truncal Fat Percentage (Week 87)

Time frame · week -3, week 87

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

Change in Truncal Fat Mass (Week 34)

Time frame · Week -3, week 34

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

Change in Truncal Fat Mass (Week 87)

Time frame · week -3, week 87

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

Change in Truncal Lean Body Mass (Week 34)

Time frame · Week -3, week 34

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

Change in Truncal Lean Body Mass (Week 87)

Time frame · week -3, week 87

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

Change in Total Fat Mass (Week 34)

Time frame · Week -3, week 34

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

Change in Total Fat Mass (Week 87)

Time frame · Week -3, week 87

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

Change in Visceral Adipose Tissue (Week 34)

Time frame · Week -3, week 34

Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).

Change in Visceral Adipose Tissue (Week 87)

Time frame · Week -3, week 87

Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).

Change in Android Fat Mass (Week 34)

Time frame · Week -3, week 34

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

Eligibility

Who can take part.

Minimum age
23 Years
Maximum age
79 Years
Sex
ALL
Healthy volunteers
No

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

Study locations

117 registered sites.

Australia · Brazil · Germany · India · Israel · Japan · Latvia · Lithuania · Malaysia · Norway · Poland · Romania · Russia · South Africa · Sweden · Turkey (Türkiye) · Ukraine · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Novo Nordisk Investigational Site

Birmingham, Alabama, United States

Novo Nordisk Investigational Site

Los Angeles, California, United States

Novo Nordisk Investigational Site

Los Angeles, California, United States

Novo Nordisk Investigational Site

Aurora, Colorado, United States

Novo Nordisk Investigational Site

Atlanta, Georgia, United States

Novo Nordisk Investigational Site

Roswell, Georgia, United States

Novo Nordisk Investigational Site

Topeka, Kansas, United States

Novo Nordisk Investigational Site

Baltimore, Maryland, United States

Novo Nordisk Investigational Site

Boston, Massachusetts, United States

Novo Nordisk Investigational Site

East Lansing, Michigan, United States

Novo Nordisk Investigational Site

St Louis, Missouri, United States

Novo Nordisk Investigational Site

Omaha, Nebraska, United States

Novo Nordisk Investigational Site

Omaha, Nebraska, United States

Novo Nordisk Investigational Site

Las Vegas, Nevada, United States

Novo Nordisk Investigational Site

Reno, Nevada, United States

Novo Nordisk Investigational Site

New York, New York, United States

Novo Nordisk Investigational Site

Cleveland, Ohio, United States

Novo Nordisk Investigational Site

Portland, Oregon, United States

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Novo Nordisk Investigational Site

Philadelphia, Pennsylvania, United States

Novo Nordisk Investigational Site

Pittsburgh, Pennsylvania, United States

Novo Nordisk Investigational Site

El Paso, Texas, United States

Novo Nordisk Investigational Site

Houston, Texas, United States

Novo Nordisk Investigational Site

Plano, Texas, United States

Related trials

More studies on Somapacitan.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.