Weekly shot could replace daily hormone injections for adults
NCT ID NCT01247675
First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time
Summary
This study tests a new once-weekly growth hormone injection (ACP-001) in adults with growth hormone deficiency. It compares three different doses of the weekly shot against a standard daily growth hormone product over four weeks. The goal is to see if the weekly injection is safe, well-tolerated, and produces similar drug levels in the body as the daily version.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ACP-001 (TransCon hGH)
- What this could lead to
- If successful, this could offer adults with growth hormone deficiency a more convenient once-weekly injection instead of daily shots.
- What could go wrong
- This is an early phase 2 study with only 37 participants over 4 weeks, so results may not apply to all patients. The weekly injection may not work as well as daily treatment or could cause unexpected side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
37 people
The number who actually took part.
- Start date
-
Nov 2010
- Finished
-
May 2011
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Aarhus University Hospital
Aarhus, 8000, Denmark
-
Charité University Hospital Berlin
Berlin, 12203, Germany
-
Karolinska University Hospital
Stockholm, 17176, Sweden
-
University Hospital Genova
Genova, 16132, Italy
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