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NCT Number: NCT01247675

A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency

This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.

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Key information

Conditions

Adult Growth Hormone Deficiency Bone Diseases Bone Diseases, Developmental Bone Diseases, Endocrine Brain Diseases Central Nervous System Diseases Dwarfism Dwarfism, Pituitary Endocrine System Diseases Hypopituitarism Hypothalamic Diseases Musculoskeletal Diseases Nervous System Diseases Pituitary Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Aarhus University Hospital, Aarhus, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female between 20 to 70 years
  • Body Mass Index (BMI, kg/m2) of 19.0 to 36.0 kg/m2, both inclusive
  • Adult Growth Hormone Deficient (AHGD) patients with documented growth hormone deficiency as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (Consensus Guidelines 1998 and 2007)
  • Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
  • GH replacement therapy for at least 3 months
  • Willing to maintain current activity level during the trial
  • Subjects are able and willing to provide written informed consent and authorization for protected health information disclosure in accordance with Good Clinical Practice (GCP)

Exclusion criteria

  • History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
  • Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. Reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence.
  • Active malignant disease or malignant disease within the last 5 years
  • Proliferative retinopathy judged by retina-photo within the last year
  • Heart insufficiency as judged by the investigator and/or NYHA 3 or greater (NYHA criteria for diagnosis of diseases of the heart, 1994)
  • Subjects with uncontrolled diabetes with an HbA1c above 8.0% and/or insulin treatment
  • Stable pituitary hormone replacement therapy for less than 3 months
  • Impaired liver function as judged by the investigator or hepatic transaminases > 2 times the upper limit of normal
  • Impaired kidney function as judged by the investigator and/or creatinine clearance <50 mL/min and/or serum creatinine > 1.4 mg/dL
  • Participation in another interventional clinical study involving an investigational compound within 3 months prior to enrolment in this study or participation in another interventional clinical study involving an investigational compound during this study.
  • Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
  • History or presence of alcohol abuse or drug abuse.
  • Patients with known history for, or presence of, anti-hGH and / or anti-PEG antibodies

Treatment and study plan

ACP-001 (TransCon hGH)

Drug

s.c., weekly injection

Omnitrope

Drug

s.c., daily injection

Primary outcomes

  1. Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)

    Time frame: Start of study treatment through Week 4

    Assessment of local tolerability was performed by examining injection sites by the investigator during study visits, and on the basis of records in the Patient Diary. Assessments included erythema, swelling, or pain.

  2. Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation

    Time frame: Start of study treatment through Day 42

    Number of subjects with treatment emergent anti-hGH binding antibodies

Secondary outcomes

  1. Cmax of hGH

    Time frame: Days 22 to 29

    As part of the following endpoint:

    Pharmacokinetic (PK) profile of serum human Growth Hormone (hGH) from ACP-001 treated dose groups compared to the PK profile of hGH from the daily Omnitrope treated group.

    Cmax (maximum value of concentration) values at Week 4

  2. Emax of IGF-I

    Time frame: Days 22 to 29

    As part of the following endpoint:

    Pharmacodynamic (PD) response of serum Insulin-like Growth Factor-I (IGF-I) from ACP-001 treated dose groups compared to the PD response of IGF-I from the daily Omnitrope treated group.

    Emax (maximum observed response) values at Week 4

Sponsors and collaborators

Lead sponsor

Ascendis Pharma A/S

Industry

Registry information

Official study title

A Phase 2, Multiple Dose, Open-Label, Parallel-Group, Active Controlled, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of ACP-001 in Adult Patients With Growth Hormone Deficiency

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 24, 2010
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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