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

NCT ID: NCT05171855

Last Updated: 2026-01-09

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-16

Study Completion Date

2024-12-23

Brief Summary

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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).

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Detailed Description

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Conditions

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Adult Growth Hormone Deficiency Endocrine System Diseases Hormone Deficiency

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Open label treatment with weekly Lonapegsomatropin
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Lonapegsomatropin

Intervention Type DRUG

Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

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.

Group Type EXPERIMENTAL

Lonapegsomatropin

Intervention Type DRUG

Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

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.

Group Type EXPERIMENTAL

Lonapegsomatropin

Intervention Type DRUG

Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

Interventions

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Lonapegsomatropin

Study participants were individually dosed with subcutaneous injection of Lonapegsomatropin once-weekly for 52 weeks.

Intervention Type DRUG

Other Intervention Names

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ACP-011

Eligibility Criteria

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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
Minimum Eligible Age

23 Years

Maximum Eligible Age

81 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascendis Pharma Endocrinology Division A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claus Strange

Role: STUDY_DIRECTOR

Ascendis Pharma A/S

Locations

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Ascendis Pharma Investigational Site

Phoenix, Arizona, United States

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Ascendis Pharma Investigational Site

Torrance, California, United States

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Ascendis Pharma Investigational Site

Chicago, Illinois, United States

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Ascendis Pharma Investigational Site

Indianapolis, Indiana, United States

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Boston, Massachusetts, United States

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Ascendis Pharma Investigational Site

Dearborn, Michigan, United States

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Rochester, Minnesota, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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New York, New York, United States

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Portland, Oregon, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

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Seattle, Washington, United States

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Yerevan, , Armenia

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Saint Leonards, New South Wales, Australia

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Sydney, New South Wales, Australia

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Box Hill, Victoria, Australia

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Fitzroy, Victoria, Australia

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Parkville, Victoria, Australia

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Perth, Western Australia, Australia

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Halifax, Nova Scotia, Canada

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Lyon, , France

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Marseille, , France

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Nantes, , France

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Tbilisi, , Georgia

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Tbilisi, , Georgia

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München, , Germany

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Athens, , Greece

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Thessaloniki, , Greece

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Haifa, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Genova, , Italy

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Rome, , Italy

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Rome, , Italy

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Kobe, Hyōgo, Japan

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Kawasaki, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Chiba, , Japan

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Fukuoka, , Japan

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Ishikawa, , Japan

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Kagoshima, , Japan

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Kawasaki, , Japan

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Kawasaki, , Japan

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Kitakyushu, , Japan

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Matsumoto, , Japan

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Miyakojima, , Japan

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Nagakute, , Japan

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Nara, , Japan

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Okayama, , Japan

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Osaka, , Japan

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Shizuoka, , Japan

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Suita, , Japan

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Yamagata, , Japan

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Yokohama, , Japan

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George Town, , Malaysia

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Malacca, , Malaysia

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Putrajaya, , Malaysia

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Krakow, , Poland

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Lodz, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Bucharest, , Romania

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Iași, , Romania

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Belgrade, , Serbia

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Bratislava, , Slovakia

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Ľubochňa, , Slovakia

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Soeul, , South Korea

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Alicante, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Seville, , Spain

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Ankara, , Turkey (Türkiye)

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Ascendis Pharma Investigational Site

Antalya, , Turkey (Türkiye)

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Aydin, , Turkey (Türkiye)

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İzmit, , Turkey (Türkiye)

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Ascendis Pharma Investigational Site

Kayseri, , Turkey (Türkiye)

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Ascendis Pharma Investigational Site

Ivano-Frankivsk, , Ukraine

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Ascendis Pharma Investigational Site

Kyiv, , Ukraine

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Ascendis Pharma Investigational Site

Kyiv, , Ukraine

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Ascendis Pharma Investigational Site

Kyiv, , Ukraine

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Ascendis Pharma Investigational Site

Vinnytsia, , Ukraine

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Ascendis Pharma Investigational Site

Leeds, , United Kingdom

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Countries

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United States Armenia Australia Canada France Georgia Germany Greece Israel Italy Japan Malaysia Poland Romania Serbia Slovakia South Korea Spain Turkey (Türkiye) Ukraine United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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TCH-306EXT

Identifier Type: -

Identifier Source: org_study_id

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