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New study tracks safety of growth hormone drug in kids

NCT ID NCT06587035

Knowledge-focused Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 14, 2026 · Updated 4 times

Summary

This study is watching for side effects in 50 children in India who are prescribed somatrogon, a long-acting growth hormone injection for growth hormone deficiency. The goal is to see how safe the drug is during routine care over 3 years. Participants do not have to visit the clinic regularly; follow-ups can be by phone.

What this could mean

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

Active substance
somatrogon (a long-acting growth hormone injection)
What this could lead to
If this study shows somatrogon is safe, it could support its continued use for children with growth hormone deficiency in India.
What could go wrong
This is an observational safety study, not a test of effectiveness. It is small (50 participants) and only monitors side effects, so it cannot prove the drug works better than other treatments.

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.

Participants

About 50 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2025

Expected to finish

Sep 2028

An estimate. End dates often move.

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.

Who is studied

Participants treated with Somatrogon will be followed by the treating physician as per routine clinical practice, who will collect and enter relevant participant data onto case report forms (CRFs).

Ages

3 to 17 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: * Prescription of Somatrogon for p GHD in participants aged 3 years or more. * Evidence of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed and agree to all pertinent aspects of the study. Assent will also be sought from children of applicable age in line with national guidance. In all cases, the treating physician responsible for enrolling the participant into the study will assess the appropriateness of gaining assent from a participant (or a legally acceptable representative) at their discretion during routine clinical care. Exclusion Criteria: * Participation in any interventional clinical trials at the time of enrollment.

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Conditions

The condition(s) this trial relates to.

isolated congenital growth hormone deficiency pituitary dwarfism

As listed by the trial registrant

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

Dwarfism, pituitary

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    4 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Apollo Children's Hospital

    RECRUITING

    Chennai, Tamil Nadu, 600006, India

  • Apollo Speciality Hospital

    RECRUITING

    Madurai, Tamil Nadu, 625020, India

  • G Kuppuswamy Naidu Memorial Hospital

    RECRUITING

    Coimbatore, Tamil Nadu, 641037, India

  • Shivajoyti Clinic

    RECRUITING

    Bengaluru, Karnataka, 560008, India

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