A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

December 18, 2025 updated by: Ascendis Pharma Endocrinology Division A/S

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia, 0075
        • Ascendis Pharma Investigational Site
  • Australia
    • New South Wales
      • Saint Leonards, New South Wales, Australia, 2065
        • Ascendis Pharma Investigational Site
      • Sydney, New South Wales, Australia, 2109
        • Ascendis Pharma Investigational Site
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Ascendis Pharma Investigational Site
      • Fitzroy, Victoria, Australia, 3065
        • Ascendis Pharma Investigational Site
      • Parkville, Victoria, Australia, 3050
        • Ascendis Pharma Investigational Site
    • Western Australia
      • Perth, Western Australia, Australia, 6009
        • Ascendis Pharma Investigational Site
  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Ascendis Pharma Investigational Site
  • France
      • Lyon, France, 69677
        • Ascendis Pharma Investigational Site
      • Marseille, France, 13385
        • Ascendis Pharma Investigational Site
      • Nantes, France, 44093
        • Ascendis Pharma Investigational Site
  • Georgia
      • Tbilisi, Georgia, 0144
        • Ascendis Pharma Investigational Site
      • Tbilisi, Georgia, 0159
        • Ascendis Pharma Investigational Site
  • Germany
      • München, Germany, 80336
        • Ascendis Pharma Investigational Site
  • Greece
      • Athens, Greece, 11527
        • Ascendis Pharma Investigational Site
      • Thessaloniki, Greece, 54636
        • Ascendis Pharma Investigational Site
  • Israel
      • Haifa, Israel, 31048
        • Ascendis Pharma Investigational Site
      • Petah Tikva, Israel, 4941480
        • Ascendis Pharma Investigational Site
      • Tel Aviv, Israel, 6423906
        • Ascendis Pharma Investigational Site
  • Italy
      • Genova, Italy, 16132
        • Ascendis Pharma Investigational Site
      • Rome, Italy, 00161
        • Ascendis Pharma Investigational Site
      • Rome, Italy, 00168
        • Ascendis Pharma Investigational Site
  • Japan
      • Chiba, Japan, 260-8677
        • Ascendis Pharma Investigational Site
      • Fukuoka, Japan, 812-8582
        • Ascendis Pharma Investigational Site
      • Ishikawa, Japan, 920-0293
        • Ascendis Pharma Investigational Site
      • Kagoshima, Japan, 890-8520
        • Ascendis Pharma Investigational Site
      • Kawasaki, Japan, 211-8533
        • Ascendis Pharma Investigational Site
      • Kawasaki, Japan, 210-0024
        • Ascendis Pharma Investigational Site
      • Kitakyushu, Japan, 807-8555
        • Ascendis Pharma Investigational Site
      • Matsumoto, Japan, 390-8510
        • Ascendis Pharma Investigational Site
      • Miyakojima, Japan, 534-0021
        • Ascendis Pharma Investigational Site
      • Nagakute, Japan, 480-1195
        • Ascendis Pharma Investigational Site
      • Nara, Japan, 634-8522
        • Ascendis Pharma Investigational Site
      • Okayama, Japan, 700-8558
        • Ascendis Pharma Investigational Site
      • Osaka, Japan, 550-0006
        • Ascendis Pharma Investigational Site
      • Shizuoka, Japan, 422-8527
        • Ascendis Pharma Investigational Site
      • Suita, Japan, 565-0871
        • Ascendis Pharma Investigational Site
      • Yamagata, Japan, 990-9585
        • Ascendis Pharma Investigational Site
      • Yokohama, Japan, 236-0004
        • Ascendis Pharma Investigational Site
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Ascendis Pharma Investigational Site
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 216-8511
        • Ascendis Pharma Investigational Site
      • Yokohama, Kanagawa, Japan, 222-0036
        • Ascendis Pharma Investigational Site
  • Malaysia
      • George Town, Malaysia, 10450
        • Ascendis Pharma Investigational Site
      • Malacca, Malaysia, 75400
        • Ascendis Pharma Investigational Site
      • Putrajaya, Malaysia, 62250
        • Ascendis Pharma Investigational Site
  • Poland
      • Krakow, Poland, 31-501
        • Ascendis Pharma Investigational Site
      • Lodz, Poland, 93-338
        • Ascendis Pharma Investigational Site
      • Warsaw, Poland, 03-242
        • Ascendis Pharma Investigational Site
      • Wroclaw, Poland, 50-367
        • Ascendis Pharma Investigational Site
  • Romania
      • Bucharest, Romania, 11868
        • Ascendis Pharma Investigational Site
      • Iași, Romania, 700106
        • Ascendis Pharma Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Ascendis Pharma Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 82606
        • Ascendis Pharma Investigational Site
      • Ľubochňa, Slovakia, 3491
        • Ascendis Pharma Investigational Site
  • South Korea
      • Soeul, South Korea, 06591
        • Ascendis Pharma Investigational Site
  • Spain
      • Alicante, Spain, 3010
        • Ascendis Pharma Investigational Site
      • Barcelona, Spain, 8035
        • Ascendis Pharma Investigational Site
      • Barcelona, Spain, 8041
        • Ascendis Pharma Investigational Site
      • Seville, Spain, 41013
        • Ascendis Pharma Investigational Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06560
        • Ascendis Pharma Investigational Site
      • Antalya, Turkey (Türkiye), 07070
        • Ascendis Pharma Investigational Site
      • Aydin, Turkey (Türkiye), 09010
        • Ascendis Pharma Investigational Site
      • Kayseri, Turkey (Türkiye), 38039
        • Ascendis Pharma Investigational Site
      • İzmit, Turkey (Türkiye), 41001
        • Ascendis Pharma Investigational Site
  • Ukraine
      • Ivano-Frankivsk, Ukraine, 76008
        • Ascendis Pharma Investigational Site
      • Kyiv, Ukraine, 04114
        • Ascendis Pharma Investigational Site
      • Kyiv, Ukraine, 03115
        • Ascendis Pharma Investigational Site
      • Kyiv, Ukraine, 04001
        • Ascendis Pharma Investigational Site
      • Vinnytsia, Ukraine, 21010
        • Ascendis Pharma Investigational Site
  • United Kingdom
      • Leeds, United Kingdom, LS9 7TF
        • Ascendis Pharma Investigational Site
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85048
        • Ascendis Pharma Investigational Site
    • California
      • Torrance, California, United States, 90509
        • Ascendis Pharma Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ascendis Pharma Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Ascendis Pharma Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ascendis Pharma Investigational Site
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Ascendis Pharma Investigational Site
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Ascendis Pharma Investigational Site
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Ascendis Pharma Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Ascendis Pharma Investigational Site
      • Reno, Nevada, United States, 89511
        • Ascendis Pharma Investigational Site
    • New York
      • New York, New York, United States, 10017
        • Ascendis Pharma Investigational Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Ascendis Pharma Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Ascendis Pharma Investigational Site
      • San Antonio, Texas, United States, 78232
        • Ascendis Pharma Investigational Site
    • Washington
      • Seattle, Washington, United States, 98108
        • Ascendis Pharma Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diabetes mellitus if any of the following were met:

    1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 7 in trial TCH-306
    2. 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lonapegsomatropin/Lonapegsomatropin
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
Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.
Other Names:
  • ACP-011
Experimental: Placebo/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
Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.
Other Names:
  • ACP-011
Experimental: Somatropin/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.
Other Names:
  • ACP-011

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs and TEAE Leading to Study Discontinuation
Time Frame: Up to 52 Weeks
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.
Up to 52 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Trunk Percent Fat at Week 52
Time Frame: Baseline main trial to week 52 (extension period)
Trunk percent fat was assessed by dual-energy X-ray absorptiometry.
Baseline main trial to week 52 (extension period)
Change From Baseline in Trunk Fat Mass at Week 52
Time Frame: Baseline main trial to week 52 (extension period)
Trunk fat mass was assessed by dual-energy X-ray absorptiometry.
Baseline main trial to week 52 (extension period)
Change From Baseline in Total Body Lean Mass at Week 52
Time Frame: Baseline main trial to week 52 (extension period)
Total body lean mass was assessed by dual-energy X-ray absorptiometry.
Baseline main trial to week 52 (extension period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascendis Pharma Endocrinology Division A/S

Investigators

  • Study Director: Claus Strange, Ascendis Pharma A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2021

Primary Completion (Actual)

December 23, 2024

Study Completion (Actual)

December 23, 2024

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

December 28, 2021

First Posted (Actual)

December 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 9, 2026

Last Update Submitted That Met QC Criteria

December 18, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCH-306EXT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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