Weekly shot could replace daily hormone injections for adults

NCT ID NCT01247675

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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