A Phase 3 interventional study of Lonapegsomatropin in Adult Growth Hormone Deficiency, Endocrine System Diseases and Hormone Deficiency, sponsored by Ascendis Pharma Endocrinology Division A/S. Completed at 85 sites in 21 countries. Open to participants aged 23 Years to 81 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Ascendis Pharma Endocrinology Division A/S · Phase 3, Interventional, and Treatment
This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants were adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt; NCT04615273).
252 studies on the registry are indexed under Dwarfism, Pituitary; 30 are open to participants now.
This study's enrollment of 220 is above the median of 60 across 169 interventional studies indexed under Dwarfism, Pituitary.
Browse Dwarfism, Pituitary studies →Ascendis Pharma Endocrinology Division A/S is the lead sponsor of 7 studies on the registry; 2 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:
Diabetes mellitus if any of the following were met:
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.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
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.
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.
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.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
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.
Participants who had completed treatment with lonapegsomatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Drug: Lonapegsomatropin
Participants who had completed treatment with placebo in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Drug: Lonapegsomatropin
Participants who had completed treatment with somatropin in TCH-306 study were enrolled in the extension study and received lonapegsomatropin administered once weekly by subcutaneous injection for a treatment period of up to 52 weeks.
Drug: Lonapegsomatropin
Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.
Also known as: ACP-011
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE was considered a TEAE if it occurred on or after the first dose of investigational product and was not present prior to the first dose, or it was present at the first dose but increased in severity during the trial. A serious AE was any untoward medical occurrence at any dose that met any of the following criteria: resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the trial drug or was considered a significant medical event by the investigator.
Time frame: Up to 52 Weeks
Change From Baseline in Trunk Percent Fat at Week 52
Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
Time frame: Baseline main trial to week 52 (extension period)
Change From Baseline in Trunk Fat Mass at Week 52
Trunk fat mass was assessed by dual-energy X-ray absorptiometry.
Time frame: Baseline main trial to week 52 (extension period)
Change From Baseline in Total Body Lean Mass at Week 52
Total body lean mass was assessed by dual-energy X-ray absorptiometry.
Time frame: Baseline main trial to week 52 (extension period)
| Milestone | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin |
|---|---|---|---|
| Started | 73 | 73 | 74 |
| Completed | 67 | 69 | 66 |
| Not completed | 6 | 4 | 8 |
| Withdrew: Death | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 | 5 |
| Withdrew: Physician decision | 1 | 0 | 0 |
| Withdrew: Adverse event | 2 | 4 | 2 |
| Withdrew: Other | 0 | 0 | 1 |
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which did not necessarily have a causal relationship with the treatment. An AE was considered a TEAE if it occurred on or after the first dose of investigational product and was not present prior to the first dose, or it was present at the first dose but increased in severity during the trial. A serious AE was any untoward medical occurrence at any dose that met any of the following criteria: resulted in death; was life threatening; required or prolonged inpatient hospitalization; resulted in persistent or significant disability/incapacity; resulted in a congenital anomaly/birth defect in a neonate/infant born to a mother exposed to the trial drug or was considered a significant medical event by the investigator.
| Participants | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin |
|---|---|---|---|
| TEAEs | 48 | 52 | 45 |
| Serious TEAEs | 7 | 4 | 5 |
| TEAE Leading to Study Discontinuation | 2 | 4 | 2 |
Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
| percent fat | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin |
|---|---|---|---|
| Change From Baseline in Trunk Percent Fat at Week 52 | -1.21 (-2.41 to -0.01) | -1.60 (-2.35 to -0.86) | -1.11 (-2.05 to -0.17) |
Trunk fat mass was assessed by dual-energy X-ray absorptiometry.
| kilograms | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin |
|---|---|---|---|
| Change From Baseline in Trunk Fat Mass at Week 52 | 0.15 (-0.47 to 0.77) | -0.16 (-0.63 to 0.31) | -0.00 (-0.53 to 0.53) |
Total body lean mass was assessed by dual-energy X-ray absorptiometry.
| kilograms | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin |
|---|---|---|---|
| Change From Baseline in Total Body Lean Mass at Week 52 | 2.26 (1.47 to 3.05) | 1.97 (1.15 to 2.80) | 2.07 (1.21 to 2.94) |
Collected over From first dose of the study drug up to Week 52. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lonapegsomatropin/Lonapegsomatropin | 1/73 (1.4%) | 7/73 (9.6%) | 25/73 (34.2%) |
| Placebo/Lonapegsomatropin | 0/73 (0%) | 4/73 (5.5%) | 29/73 (39.7%) |
| Somatropin/Lonapegsomatropin | 0/74 (0%) | 5/74 (6.8%) | 21/74 (28.4%) |
| Event | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin |
|---|---|---|---|
| SepsisInfections and infestations | 2/73 | 0/73 | 0/74 |
| Clostridium difficile colitisInfections and infestations | 1/73 | 0/73 | 0/74 |
| Norovirus infectionInfections and infestations | 1/73 | 0/73 | 0/74 |
| Adrenocortical insufficiency acuteEndocrine disorders | 1/73 | 0/73 | 0/74 |
| HyperparathyroidismEndocrine disorders | 1/73 | 0/73 | 0/74 |
| Cerebrovascular accidentNervous system disorders | 1/73 | 0/73 | 0/74 |
| SeizureNervous system disorders | 0/73 | 1/73 | 0/74 |
| EnterocolitisGastrointestinal disorders | 1/73 | 0/73 | 0/74 |
| GastritisGastrointestinal disorders | 1/73 | 0/73 | 0/74 |
| Abdominal herniaGastrointestinal disorders | 0/73 | 1/73 | 0/74 |
| Event | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin |
|---|---|---|---|
| NasopharyngitisInfections and infestations | 12/73 | 6/73 | 2/74 |
| Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders | 7/73 | 7/73 | 8/74 |
| DizzinessNervous system disorders | 0/73 | 6/73 | 4/74 |
| InfluenzaInfections and infestations | 0/73 | 6/73 | 0/74 |
| HeadacheGeneral disorders | 5/73 | 5/73 | 4/74 |
| Back painMusculoskeletal and connective tissue disorders | 2/73 | 5/73 | 2/74 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 2/73 | 5/73 | 1/74 |
| GastroenteritisGastrointestinal disorders | 2/73 | 5/73 | 1/74 |
| Haematocrit increasedInvestigations | 0/73 | 5/73 | 1/74 |
| COVID-19Infections and infestations | 4/73 | 4/73 | 2/74 |
Analysis was performed on all participants who were exposed to any amount of the trial drug in the study TCH-306 EXT.
| Age, Customized(Participants) | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin | Total |
|---|---|---|---|---|
| < 30 years | 10 | 13 | 14 | 37 |
| >= 30 to <= 60 years | 53 | 51 | 52 | 156 |
| > 60 years | 10 | 9 | 8 | 27 |
| Sex: Female, Male(Participants) | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin | Total |
|---|---|---|---|---|
| Female | 37 | 32 | 31 | 100 |
| Male | 36 | 41 | 43 | 120 |
| Ethnicity (NIH/OMB)(Participants) | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin | Total |
|---|---|---|---|---|
| Hispanic or Latino | 3 | 3 | 5 | 11 |
| Not Hispanic or Latino | 68 | 69 | 67 | 204 |
| Unknown or Not Reported | 2 | 1 | 2 | 5 |
| Race/Ethnicity, Customized(Participants) | Lonapegsomatropin/Lonapegsomatropin | Placebo/Lonapegsomatropin | Somatropin/Lonapegsomatropin | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 0 | 1 |
| Asian | 9 | 7 | 8 | 24 |
| Black or African American | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| White | 59 | 62 | 64 | 185 |
| Other | 5 | 3 | 1 | 9 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2021 to primary completion in Dec 2024, 36 months.
Results were first posted in Jan 2026, 1 year after primary completion.
Of 19 phase 3 interventional studies under Dwarfism, Pituitary, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 30. This study's 36 months is above that.
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: Lonapegsomatropin
Ascendis Pharma Endocrinology Division A/S