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About the heiGHt Trial

Over the past 25 years, daily hGH has been optimized for treating GHD. Daily injections can be difficult for children and families. Research shows two out of three patients miss more than one injection on average per week.1 Poor compliance with daily hGH therapy is associated with reduced height velocity and impaired quality of life.1

The once-weekly TransCon Growth Hormone being studied in the heiGHt Trial contains somatropin, the same active ingredient in daily hGH products, in a sustained-release formulation. It is also the only long-acting growth hormone in development that delivers native hGH. The hope is that fewer injections may be preferable to children and their families, so fewer doses may be missed. In turn, this may lead to better treatment outcomes.

Growth hormone treatment for children

Phase 3 heiGHt Trial highlights

  • Randomized, open-label, active-controlled global trial comparing once-weekly TransCon Growth Hormone to daily hGH (Genotropin® [somatropin (rDNA origin) for injection]) in children with GHD
  • Approximately 150 hGH-treatment naïve children with GHD will be included (see main inclusion/exclusion criteria below)
  • Randomization in a 2:1 ratio (TransCon Growth Hormone:Genotropin)
  • Non-inferiority design
  • Primary endpoint: Height velocity at 52 weeks

Main inclusion/exclusion criteria

Inclusion Criteria
  • Pre-pubertal children
  • Boys, age 3–12; girls, age 3–11
  • Bone age (BA) at least 6 months less than chronological age
  • Impaired height ≥2 standard deviations (SD) below mean
  • GHD diagnosis confirmed by 2 different growth hormone stimulation tests
  • Insulin-like growth factor-1 (IGF-1) ≥1 SD below mean
Exclusion Criteria
  • Prior exposure to recombinant hGH or IGF-1
  • Idiopathic short stature
  • Known chromosomal abnormalities
  • Small for gestational age (SGA)
  • Major medical condition (including history/presence of malignancy) and/or contraindications to hGH
  • Clinical trial participation within 3 months

Once-weekly TransCon Growth Hormone

TransCon Growth Hormone is a sustained-release prodrug that predictably delivers native hGH in the same therapeutic range as approved daily hGH products.

Phase 2 Results

In a Phase 2 clinical trial, comparable efficacy and safety were observed between once-weekly TransCon Growth Hormone and daily hGH in pediatric patients with GHD.2,3

Mean annualized height velocity at 6 months2,3

TransCon Growth Hormone is an investigational product in clinical studies for use in children with GHD. TransCon Growth Hormone has not been approved by any regulatory agency for this investigational use, and, as such, may not be safe or effective.

The heiGHt Trial is sponsored by Ascendis Pharma Endocrinology Division A/S; a company in the Ascendis Pharma group.

1. Cutfield WS, Derraik JGB, Gunn AJ, et al. PLoS One. 2011;6(1):e16223.
2. Chatelain P, Malievsky O, Radziuk K, Senatorova G, Beckert M. Poster presented at: 54th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE); October 1-3, 2015; Barcelona, Spain.
3. Chatelain P et al. Oral presentation at: 98th Annual Meeting of the Endocrine Society (ENDO); April 1-4, 2016; Boston, Massachusetts.
4. European Medicines Agency. Assessment report Somatropin Biopartners EMEA/H/C/002196/0000. May 30, 2013. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Public_assessment_report/human/002196/WC500148755.pdf. Accessed March 24, 2016.