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

Last updated: January 15, 2025
Sponsor: Ascendis Pharma Endocrinology Division A/S
Overall Status: Completed

Phase

3

Condition

Growth Hormone Deficiencies/abnormalities

Treatment

Lonapegsomatropin

Clinical Study ID

NCT05171855
TCH-306EXT
  • Ages 23-81
  • All Genders

Study Summary

This is 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 are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).

Eligibility Criteria

Inclusion

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 DXA scan

  • Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranialhypertension or diabetic retinopathy stage 2 / moderate or above

Exclusion

Exclusion Criteria:

  • Diabetes mellitus if any of the following are met:
  1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according tocentral laboratory at Visit 6 in trial TCH-306

  2. Use of diabetes mellitus drugs other than metformin and/or dipeptidylpeptidase-4 (DPP-4) inhibitors

  • Active malignant disease or history of malignancy. Exceptions are:
  1. Resection of in situ carcinoma of the cervix uteri

  2. Complete eradication of squamous cell or basal cell carcinoma of the skin

  • Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)

  • Female who is pregnant, plans to become pregnant, or is breastfeeding

  • Female participant of childbearing potential (i.e., fertile, following menarche anduntil becoming post-menopausal unless permanently sterile) not willing throughoutthe trial to use contraceptives as required by local law or practice. Detailsincluded in Appendix 4/section 10.4 of the protocol

  • Male participant not willing throughout the trial to use contraceptives as requiredby local law or practice. Details included in Appendix 4/ section 10.4 of theprotocol

  • Any disease or condition that, in the judgement of the investigator, may make theparticipant unlikely to comply with the requirements of the protocol or anycondition that presents undue risk from the investigational product or trialprocedures

Study Design

Total Participants: 233
Treatment Group(s): 1
Primary Treatment: Lonapegsomatropin
Phase: 3
Study Start date:
December 16, 2021
Estimated Completion Date:
December 23, 2024

Connect with a study center

  • Ascendis Pharma Investigational Site

    Yerevan, 0075
    Armenia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Saint Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Sydney, New South Wales 2109
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Fitzroy, Victoria 3065
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Halifax, Nova Scotia B3H 1V7
    Canada

    Site Not Available

  • Ascendis Pharma Investigational Site

    Lyon, 69677
    France

    Site Not Available

  • Ascendis Pharma Investigational Site

    Marseille, 13385
    France

    Site Not Available

  • Ascendis Pharma Investigational Site

    Nantes, 44093
    France

    Site Not Available

  • Ascendis Pharma Investigational Site

    Tbilisi, 0159
    Georgia

    Site Not Available

  • Ascendis Pharma Investigational Site

    München, 80336
    Germany

    Site Not Available

  • Ascendis Pharma Investigational Site

    Athens, 11527
    Greece

    Site Not Available

  • Ascendis Pharma Investigational Site

    Thessaloníki, 54636
    Greece

    Site Not Available

  • Ascendis Pharma Investigational Site

    Haifa, 31048
    Israel

    Site Not Available

  • Ascendis Pharma Investigational Site

    Petah tikva, 4941480
    Israel

    Site Not Available

  • Ascendis Pharma Investigational Site

    Tel Aviv, 6423906
    Israel

    Site Not Available

  • Ascendis Pharma Investigational Site

    Genova, 16132
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Rome, 00168
    Italy

    Site Not Available

  • Ascendis Pharma Investigational Site

    Kobe, Hyogo 650-0047
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Chiba, 260-8677
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Fukuoka, 812-8582
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Ishikawa, 920-0293
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Kagoshima, 890-8520
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Kawasaki, 210-0024
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Kitakyushu, 807-8555
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Matsumoto, 390-8510
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Miyakojima, 534-0021
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Nagakute, 480-1195
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Nara, 634-8522
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Okayama, 700-8558
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Osaka, 550-0006
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Shizuoka, 422-8527
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Suita, 565-0871
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Yamagata, 990-9585
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Yokohama, 236-0004
    Japan

    Site Not Available

  • Ascendis Pharma Investigational Site

    Soeul, 06591
    Korea, Republic of

    Site Not Available

  • Ascendis Pharma Investigational Site

    George Town, 10450
    Malaysia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Melaka, 75400
    Malaysia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Putrajaya, 62250
    Malaysia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Kraków, 31-501
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Warszawa, 03-242
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Wrocław, 50-367
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Łódź, 93-338
    Poland

    Site Not Available

  • Ascendis Pharma Investigational Site

    Bucharest, 11868
    Romania

    Site Not Available

  • Ascendis Pharma Investigational Site

    Iaşi, 700106
    Romania

    Site Not Available

  • Ascendis Pharma Investigational Site

    Belgrade, 11000
    Serbia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Bratislava, 82606
    Slovakia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Ľubochňa, 3491
    Slovakia

    Site Not Available

  • Ascendis Pharma Investigational Site

    Alicante, 3010
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Barcelona, 8035
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Sevilla, 41013
    Spain

    Site Not Available

  • Ascendis Pharma Investigational Site

    Ankara, 06560
    Turkey

    Site Not Available

  • Ascendis Pharma Investigational Site

    Antalya, 07070
    Turkey

    Site Not Available

  • Ascendis Pharma Investigational Site

    Aydın, 09010
    Turkey

    Site Not Available

  • Ascendis Pharma Investigational Site

    Kayseri, 38039
    Turkey

    Site Not Available

  • Ascendis Pharma Investigational Site

    İzmit, 41001
    Turkey

    Site Not Available

  • Ascendis Pharma Investigational Site

    Ivano-Frankivs'k, 76008
    Ukraine

    Site Not Available

  • Ascendis Pharma Investigational Site

    Kyiv, 03115
    Ukraine

    Site Not Available

  • Ascendis Pharma Investigational Site

    Vinnytsia, 21010
    Ukraine

    Site Not Available

  • Ascendis Pharma Investigational Site

    Leeds, LS9 7TF
    United Kingdom

    Site Not Available

  • Ascendis Pharma Investigational Site

    Phoenix, Arizona 85048
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Torrance, California 90509
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Dearborn, Michigan 48126
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Reno, Nevada 89511
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    New York, New York 10017
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Portland, Oregon 97239
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Dallas, Texas 75390
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    San Antonio, Texas 78232
    United States

    Site Not Available

  • Ascendis Pharma Investigational Site

    Seattle, Washington 98108
    United States

    Site Not Available

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