Adult Growth Hormone DeficiencyPhase 3NCT05171855
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
A Phase 3 study testing Lonapegsomatropin in people with Adult Growth Hormone Deficiency and Endocrine System Diseases, run by Ascendis Pharma Endocrinology Division A/S at 85 sites in 21 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 23 to 81 years
- Conditions the study is for
- Adult Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency
- What is being tested?
- Lonapegsomatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 85 sitesin 21 countries
- Study dates
- 16 Dec 2021to 23 Dec 2024
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signing of the trial specific informed consent
- Completion of the treatment period and Visit 7 assessments of trial TCH-306, including collection and upload of Visit 7 dual-X-ray-absorptiometry (DXA) scan
- Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above
Who cannot join
- Diabetes mellitus if any of the following were met:
- Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 7 in trial TCH-306
- Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
- Active malignant disease or history of malignancy.
- Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
- Female who was pregnant, plans to become pregnant, or was breastfeeding
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- Female participant of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/section 10.4 of the protocol
- Male participant not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/ section 10.4 of the protocol
- Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures
Trial locations and contacts
85 sites in 21 countries.
85 sites in 21 countries
Japan20 sites
Ascendis Pharma Investigational Site
Chiba, 260-8677
Ascendis Pharma Investigational Site
Fukuoka, 812-8582
Ascendis Pharma Investigational Site
Ishikawa, 920-0293
Ascendis Pharma Investigational Site
Kagoshima, 890-8520
Ascendis Pharma Investigational Site
Kawasaki, Kanagawa, 216-8511
Ascendis Pharma Investigational Site
Kawasaki, 210-0024
Ascendis Pharma Investigational Site
Kawasaki, 211-8533
Ascendis Pharma Investigational Site
Kitakyushu, 807-8555
Ascendis Pharma Investigational Site
Kobe, Hyōgo, 650-0047
Ascendis Pharma Investigational Site
Matsumoto, 390-8510
Ascendis Pharma Investigational Site
Miyakojima, 534-0021
Ascendis Pharma Investigational Site
Nagakute, 480-1195
Ascendis Pharma Investigational Site
Nara, 634-8522
Ascendis Pharma Investigational Site
Okayama, 700-8558
Ascendis Pharma Investigational Site
Osaka, 550-0006
Ascendis Pharma Investigational Site
Shizuoka, 422-8527
Ascendis Pharma Investigational Site
Suita, 565-0871
Ascendis Pharma Investigational Site
Yamagata, 990-9585
Ascendis Pharma Investigational Site
Yokohama, Kanagawa, 222-0036
Ascendis Pharma Investigational Site
Yokohama, 236-0004
United States15 sites
Ascendis Pharma Investigational Site
Boston, Massachusetts, 02114
Ascendis Pharma Investigational Site
Chicago, Illinois, 60611
Ascendis Pharma Investigational Site
Dallas, Texas, 75390
Ascendis Pharma Investigational Site
Dearborn, Michigan, 48126
Ascendis Pharma Investigational Site
Indianapolis, Indiana, 46202
Ascendis Pharma Investigational Site
Las Vegas, Nevada, 89148
Ascendis Pharma Investigational Site
New York, New York, 10017
Ascendis Pharma Investigational Site
Phoenix, Arizona, 85048
Ascendis Pharma Investigational Site
Portland, Oregon, 97239
Ascendis Pharma Investigational Site
Reno, Nevada, 89511
Ascendis Pharma Investigational Site
Rochester, Minnesota, 55905
Ascendis Pharma Investigational Site
San Antonio, Texas, 78232
Ascendis Pharma Investigational Site
Seattle, Washington, 98108
Ascendis Pharma Investigational Site
St Louis, Missouri, 63110
Ascendis Pharma Investigational Site
Torrance, California, 90509
Australia6 sites
Ascendis Pharma Investigational Site
Box Hill, Victoria, 3128
Ascendis Pharma Investigational Site
Fitzroy, Victoria, 3065
Ascendis Pharma Investigational Site
Parkville, Victoria, 3050
Ascendis Pharma Investigational Site
Perth, Western Australia, 6009
Ascendis Pharma Investigational Site
Saint Leonards, New South Wales, 2065
Ascendis Pharma Investigational Site
Sydney, New South Wales, 2109
Turkey (Türkiye)5 sites
Ascendis Pharma Investigational Site
Ankara, 06560
Ascendis Pharma Investigational Site
Antalya, 07070
Ascendis Pharma Investigational Site
Aydin, 09010
Ascendis Pharma Investigational Site
İzmit, 41001
Ascendis Pharma Investigational Site
Kayseri, 38039
Ukraine5 sites
Ascendis Pharma Investigational Site
Ivano-Frankivsk, 76008
Ascendis Pharma Investigational Site
Kyiv, 03115
Ascendis Pharma Investigational Site
Kyiv, 04001
Ascendis Pharma Investigational Site
Kyiv, 04114
Ascendis Pharma Investigational Site
Vinnytsia, 21010
Poland4 sites
Ascendis Pharma Investigational Site
Krakow, 31-501
Ascendis Pharma Investigational Site
Lodz, 93-338
Ascendis Pharma Investigational Site
Warsaw, 03-242
Ascendis Pharma Investigational Site
Wroclaw, 50-367
Spain4 sites
Ascendis Pharma Investigational Site
Alicante, 3010
Ascendis Pharma Investigational Site
Barcelona, 8035
Ascendis Pharma Investigational Site
Barcelona, 8041
Ascendis Pharma Investigational Site
Seville, 41013
France3 sites
Ascendis Pharma Investigational Site
Lyon, 69677
Ascendis Pharma Investigational Site
Marseille, 13385
Ascendis Pharma Investigational Site
Nantes, 44093
Israel3 sites
Ascendis Pharma Investigational Site
Haifa, 31048
Ascendis Pharma Investigational Site
Petah Tikva, 4941480
Ascendis Pharma Investigational Site
Tel Aviv, 6423906
Italy3 sites
Ascendis Pharma Investigational Site
Genova, 16132
Ascendis Pharma Investigational Site
Rome, 00161
Ascendis Pharma Investigational Site
Rome, 00168
Malaysia3 sites
Ascendis Pharma Investigational Site
George Town, 10450
Ascendis Pharma Investigational Site
Malacca, 75400
Ascendis Pharma Investigational Site
Putrajaya, 62250
Georgia2 sites
Ascendis Pharma Investigational Site
Tbilisi, 0144
Ascendis Pharma Investigational Site
Tbilisi, 0159
Greece2 sites
Ascendis Pharma Investigational Site
Athens, 11527
Ascendis Pharma Investigational Site
Thessaloniki, 54636
Romania2 sites
Ascendis Pharma Investigational Site
Bucharest, 11868
Ascendis Pharma Investigational Site
Iași, 700106
Slovakia2 sites
Ascendis Pharma Investigational Site
Bratislava, 82606
Ascendis Pharma Investigational Site
Ľubochňa, 3491
Canada1 site
Ascendis Pharma Investigational Site
Halifax, Nova Scotia, B3H 1V7
United Kingdom1 site
Ascendis Pharma Investigational Site
Leeds, LS9 7TF
About this study
Official title: A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
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).
- Being tested
- Lonapegsomatropin
- Keywords
- Human Growth Hormone, hGH, rhGH, GHD, Adult Growth Hormone Deficiency, Long Acting Growth Hormone, Lonapegsomatropin, Prodrug, Growth Hormone Replacement Therapy, Sustained Release Growth Hormone, Growth Hormone Deficiency, TransCon hGH, Skytrofa
- Medical subject headings
- Dwarfism, Pituitary, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LonapegsomatropinDrug
Also called ACP-011
Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Lonapegsomatropin/Lonapegsomatropin | Experimental | 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. Receives: Drug: Lonapegsomatropin |
| Placebo/Lonapegsomatropin | Experimental | 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. Receives: Drug: Lonapegsomatropin |
| Somatropin/Lonapegsomatropin | Experimental | 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. Receives: Drug: Lonapegsomatropin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 52 Weeks
Secondary outcomes (3)
Change From Baseline in Trunk Percent Fat at Week 52
Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
Measured: 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.
Measured: 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.
Measured: Baseline main trial to week 52 (extension period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start16 Dec 2021
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Growth Hormone DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Open label treatment with weekly Lonapegsomatropin
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascendis Pharma Endocrinology Division A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, MD, Study director, Ascendis Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171855
- Sponsor's protocol ID
- TCH-306EXT
- Status last verified
- Jun 2026
- First submitted
- 24 Sep 2021
- Last updated
- 7 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No