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Weekly shot shows promise for adult growth hormone deficiency in Long-Term trial

NCT ID NCT05171855

Disease control Sponsor: Ascendis Pharma Endocrinology Division A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 08, 2026 · Updated 3 times

Summary

This study tested a once-weekly injection called lonapegsomatropin in 220 adults with growth hormone deficiency who had already completed a previous trial. The goal was to see if the drug remains safe and effective over a full year. Participants received the injection for 52 weeks, and researchers tracked side effects and changes in body fat and muscle mass.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lonapegsomatropin (a once-weekly injection of a long-acting growth hormone)
What this could lead to
If successful, this could provide a convenient once-weekly treatment option for adults with growth hormone deficiency, potentially improving body composition and quality of life.
What could go wrong
This is an extension study, meaning participants already knew the drug was safe enough to continue. It is not a new breakthrough, and long-term risks or lack of efficacy remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

220 people

The number who actually took part.

Started

Dec 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

23 to 81 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

endocrine system disorder pituitary dwarfism

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult growth hormone deficiency Endocrine system diseases Hormone deficiency

Contacts and locations

Locations

  • Ascendis Pharma Investigational Site

    Phoenix, Arizona, 85048, United States

  • Ascendis Pharma Investigational Site

    Torrance, California, 90509, United States

  • Ascendis Pharma Investigational Site

    Chicago, Illinois, 60611, United States

  • Ascendis Pharma Investigational Site

    Indianapolis, Indiana, 46202, United States

  • Ascendis Pharma Investigational Site

    Boston, Massachusetts, 02114, United States

  • Ascendis Pharma Investigational Site

    Dearborn, Michigan, 48126, United States

  • Ascendis Pharma Investigational Site

    Rochester, Minnesota, 55905, United States

  • Ascendis Pharma Investigational Site

    St Louis, Missouri, 63110, United States

  • Ascendis Pharma Investigational Site

    Las Vegas, Nevada, 89148, United States

  • Ascendis Pharma Investigational Site

    Reno, Nevada, 89511, United States

  • Ascendis Pharma Investigational Site

    New York, New York, 10017, United States

  • Ascendis Pharma Investigational Site

    Portland, Oregon, 97239, United States

  • Ascendis Pharma Investigational Site

    Dallas, Texas, 75390, United States

  • Ascendis Pharma Investigational Site

    San Antonio, Texas, 78232, United States

  • Ascendis Pharma Investigational Site

    Seattle, Washington, 98108, United States

  • Ascendis Pharma Investigational Site

    Yerevan, 0075, Armenia

  • Ascendis Pharma Investigational Site

    Saint Leonards, New South Wales, 2065, Australia

  • Ascendis Pharma Investigational Site

    Sydney, New South Wales, 2109, Australia

  • Ascendis Pharma Investigational Site

    Box Hill, Victoria, 3128, Australia

  • Ascendis Pharma Investigational Site

    Fitzroy, Victoria, 3065, Australia

  • Ascendis Pharma Investigational Site

    Parkville, Victoria, 3050, Australia

  • Ascendis Pharma Investigational Site

    Perth, Western Australia, 6009, Australia

  • Ascendis Pharma Investigational Site

    Halifax, Nova Scotia, B3H 1V7, Canada

  • Ascendis Pharma Investigational Site

    Lyon, 69677, France

  • Ascendis Pharma Investigational Site

    Marseille, 13385, France

  • Ascendis Pharma Investigational Site

    Nantes, 44093, France

  • Ascendis Pharma Investigational Site

    Tbilisi, 0144, Georgia

  • Ascendis Pharma Investigational Site

    Tbilisi, 0159, Georgia

  • Ascendis Pharma Investigational Site

    München, 80336, Germany

  • Ascendis Pharma Investigational Site

    Athens, 11527, Greece

  • Ascendis Pharma Investigational Site

    Thessaloniki, 54636, Greece

  • Ascendis Pharma Investigational Site

    Haifa, 31048, Israel

  • Ascendis Pharma Investigational Site

    Petah Tikva, 4941480, Israel

  • Ascendis Pharma Investigational Site

    Tel Aviv, 6423906, Israel

  • Ascendis Pharma Investigational Site

    Genova, 16132, Italy

  • Ascendis Pharma Investigational Site

    Rome, 00161, Italy

  • Ascendis Pharma Investigational Site

    Rome, 00168, Italy

  • Ascendis Pharma Investigational Site

    Kobe, Hyōgo, 650-0047, Japan

  • Ascendis Pharma Investigational Site

    Kawasaki, Kanagawa, 216-8511, Japan

  • Ascendis Pharma Investigational Site

    Yokohama, Kanagawa, 222-0036, Japan

  • Ascendis Pharma Investigational Site

    Chiba, 260-8677, Japan

  • Ascendis Pharma Investigational Site

    Fukuoka, 812-8582, Japan

  • Ascendis Pharma Investigational Site

    Ishikawa, 920-0293, Japan

  • Ascendis Pharma Investigational Site

    Kagoshima, 890-8520, Japan

  • Ascendis Pharma Investigational Site

    Kawasaki, 210-0024, Japan

  • Ascendis Pharma Investigational Site

    Kawasaki, 211-8533, Japan

  • Ascendis Pharma Investigational Site

    Kitakyushu, 807-8555, Japan

  • Ascendis Pharma Investigational Site

    Matsumoto, 390-8510, Japan

  • Ascendis Pharma Investigational Site

    Miyakojima, 534-0021, Japan

  • Ascendis Pharma Investigational Site

    Nagakute, 480-1195, Japan

  • Ascendis Pharma Investigational Site

    Nara, 634-8522, Japan

  • Ascendis Pharma Investigational Site

    Okayama, 700-8558, Japan

  • Ascendis Pharma Investigational Site

    Osaka, 550-0006, Japan

  • Ascendis Pharma Investigational Site

    Shizuoka, 422-8527, Japan

  • Ascendis Pharma Investigational Site

    Suita, 565-0871, Japan

  • Ascendis Pharma Investigational Site

    Yamagata, 990-9585, Japan

  • Ascendis Pharma Investigational Site

    Yokohama, 236-0004, Japan

  • Ascendis Pharma Investigational Site

    George Town, 10450, Malaysia

  • Ascendis Pharma Investigational Site

    Malacca, 75400, Malaysia

  • Ascendis Pharma Investigational Site

    Putrajaya, 62250, Malaysia

  • Ascendis Pharma Investigational Site

    Krakow, 31-501, Poland

  • Ascendis Pharma Investigational Site

    Lodz, 93-338, Poland

  • Ascendis Pharma Investigational Site

    Warsaw, 03-242, Poland

  • Ascendis Pharma Investigational Site

    Wroclaw, 50-367, Poland

  • Ascendis Pharma Investigational Site

    Bucharest, 11868, Romania

  • Ascendis Pharma Investigational Site

    Iași, 700106, Romania

  • Ascendis Pharma Investigational Site

    Belgrade, 11000, Serbia

  • Ascendis Pharma Investigational Site

    Bratislava, 82606, Slovakia

  • Ascendis Pharma Investigational Site

    Ľubochňa, 3491, Slovakia

  • Ascendis Pharma Investigational Site

    Soeul, 06591, South Korea

  • Ascendis Pharma Investigational Site

    Alicante, 3010, Spain

  • Ascendis Pharma Investigational Site

    Barcelona, 8035, Spain

  • Ascendis Pharma Investigational Site

    Barcelona, 8041, Spain

  • Ascendis Pharma Investigational Site

    Seville, 41013, Spain

  • Ascendis Pharma Investigational Site

    Ankara, 06560, Turkey (Türkiye)

  • Ascendis Pharma Investigational Site

    Antalya, 07070, Turkey (Türkiye)

  • Ascendis Pharma Investigational Site

    Aydin, 09010, Turkey (Türkiye)

  • Ascendis Pharma Investigational Site

    İzmit, 41001, Turkey (Türkiye)

  • Ascendis Pharma Investigational Site

    Kayseri, 38039, Turkey (Türkiye)

  • Ascendis Pharma Investigational Site

    Ivano-Frankivsk, 76008, Ukraine

  • Ascendis Pharma Investigational Site

    Kyiv, 03115, Ukraine

  • Ascendis Pharma Investigational Site

    Kyiv, 04001, Ukraine

  • Ascendis Pharma Investigational Site

    Kyiv, 04114, Ukraine

  • Ascendis Pharma Investigational Site

    Vinnytsia, 21010, Ukraine

  • Ascendis Pharma Investigational Site

    Leeds, LS9 7TF, United Kingdom

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