A Phase 2 interventional study of ACP-001 (TransCon hGH) and ACP-001 (TransCon hGH) in Adult Growth Hormone Deficiency, sponsored by Ascendis Pharma A/S. Completed at 4 sites in 4 countries. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by Ascendis Pharma A/S · Phase 2, Interventional, and Treatment
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.
252 studies on the registry are indexed under Dwarfism, Pituitary; 30 are open to participants now.
This study's enrollment of 37 is below the median of 60 across 169 interventional studies indexed under Dwarfism, Pituitary.
Browse Dwarfism, Pituitary studies →Ascendis Pharma A/S is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Once weekly subcutaneous injection of ACP-001 equivalent to 0.02 mg hGH/kg/week for 4 weeks
Drug: ACP-001 (TransCon hGH)
Once weekly subcutaneous injection of ACP-001 equivalent to 0.04 mg hGH/kg/week for 4 weeks
Drug: ACP-001 (TransCon hGH)
Once weekly subcutaneous injection of ACP-001 equivalent to 0.08 mg hGH/kg/week for 4 weeks
Drug: ACP-001 (TransCon hGH)
Once daily subcutaneous injection of human Growth Hormone (Omnitrope) equivalent to 0.04 mg hGH/kg/week for 4 weeks
Drug: Omnitrope
s.c., weekly injection
s.c., weekly injection
s.c., weekly injection
s.c., daily injection
Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator)
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.
Time frame: Start of study treatment through Week 4
Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation
Number of subjects with treatment emergent anti-hGH binding antibodies
Time frame: Start of study treatment through Day 42
Cmax of hGH
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
Time frame: Days 22 to 29
Emax of IGF-I
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
Time frame: Days 22 to 29
| Milestone | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk |
|---|---|---|---|---|
| Started | 10 | 10 | 9 | 8 |
| Completed | 8 | 8 | 9 | 8 |
| Not completed | 2 | 2 | 0 | 0 |
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.
| Number of subjects with any symptom | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk |
|---|---|---|---|---|
| Number of Subjects Reporting Local Tolerability Events (Assessed by the Patient and Investigator) | 3 | 3 | 2 | 1 |
Number of subjects with treatment emergent anti-hGH binding antibodies
| Participants | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk |
|---|---|---|---|---|
| Incidence of Treatment Emergent Anti-hGH Binding Antibody Formation | 0 | 0 | 0 | 0 |
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
| ng/mL | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk |
|---|---|---|---|---|
| Cmax of hGH | 1.2 ± 0.8 | 1.9 ± 0.9 | 3.8 ± 2.0 | 2.0 ± 1.1 |
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
| ng/mL | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk |
|---|---|---|---|---|
| Emax of IGF-I | 71.8 ± 26.9 | 108.6 ± 91.7 | 125.6 ± 70.1 | 109.8 ± 37.1 |
Collected over Reported Adverse Events include events starting on or after Day 0 and ending on or before Day 42.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ACP-001, 0.02 mg hGH/kg/wk | 0/10 (0%) | 1/10 (10%) | 6/10 (60%) |
| ACP-001, 0.04 mg hGH/kg/wk | 0/10 (0%) | 0/10 (0%) | 9/10 (90%) |
| ACP-001, 0.08 mg hGH/kg/wk | 0/9 (0%) | 0/9 (0%) | 7/9 (77.8%) |
| Omnitrope, 0.04 mg hGH/kg/wk | 0/8 (0%) | 0/8 (0%) | 7/8 (87.5%) |
| Event | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk |
|---|---|---|---|---|
| Severe Adrenal CrisisEndocrine disorders | 1/10 | 0/10 | 0/9 | 0/8 |
| Pleuritic PainRespiratory, thoracic and mediastinal disorders | 1/10 | 0/10 | 0/9 | 0/8 |
| Event | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk |
|---|---|---|---|---|
| FatigueGeneral disorders | 3/10 | 3/10 | 1/9 | 2/8 |
| NauseaGastrointestinal disorders | 0/10 | 3/10 | 2/9 | 1/8 |
| Oropharyngeal painRespiratory, thoracic and mediastinal disorders | 1/10 | 3/10 | 2/9 | 2/8 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/10 | 3/10 | 0/9 | 0/8 |
| HeadacheNervous system disorders | 2/10 | 3/10 | 2/9 | 2/8 |
| NasopharyngitisInfections and infestations | 0/10 | 1/10 | 2/9 | 2/8 |
| StressPsychiatric disorders | 0/10 | 0/10 | 0/9 | 2/8 |
| HematuriaRenal and urinary disorders | 0/10 | 0/10 | 0/9 | 2/8 |
| Back painMusculoskeletal and connective tissue disorders | 1/10 | 0/10 | 2/9 | 0/8 |
| Application site erythemaGeneral disorders | 2/10 | 0/10 | 0/9 | 1/8 |
| Age, Continuous(years) | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk | Total |
|---|---|---|---|---|---|
| Mean | 55.7 ± 12.6 | 45.9 ± 15.0 | 51.6 ± 18.1 | 44.0 ± 15.7 | 49.5 ± 15.4 |
| Sex: Female, Male(Participants) | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk | Total |
|---|---|---|---|---|---|
| Female | 5 | 6 | 5 | 3 | 19 |
| Male | 5 | 4 | 4 | 5 | 18 |
| Weight(kg) | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk | Total |
|---|---|---|---|---|---|
| Mean | 82.3 ± 19.8 | 79.6 ± 17.0 | 92.5 ± 20.5 | 74.7 ± 16.6 | 82.4 ± 18.9 |
| Body Mass Index(kg/m²) | ACP-001, 0.02 mg hGH/kg/wk | ACP-001, 0.04 mg hGH/kg/wk | ACP-001, 0.08 mg hGH/kg/wk | Omnitrope, 0.04 mg hGH/kg/wk | Total |
|---|---|---|---|---|---|
| Mean | 27.6 ± 4.4 | 27.9 ± 4.4 | 30.7 ± 4.4 | 25.7 ± 4.4 | 28.0 ± 4.6 |
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Nov 2010, a primary completion of May 2011 and a completion of May 2011. It does not say whether these dates are actual or estimated.
Results were first posted in Mar 2017, 5 years 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: ACP-001
Ascendis Pharma A/S