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Healthy women help compare two versions of sotatercept

NCT ID NCT06930664

Knowledge-focused Sponsor: Merck Sharp & Dohme LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This completed Phase 1 study tested two forms of the drug sotatercept in 146 healthy women who cannot become pregnant. One form is a liquid in an autoinjector pen, the other is a powder that must be mixed before injection. The goal was simply to see how the body absorbs and processes each version, not to treat any disease.

What this could mean

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

Active substance
sotatercept

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

146 people

The number who actually took part.

Started

May 2025

Finished

Nov 2025

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

18 to 85 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has a body weight between 75 and 100 kg, inclusive * Is assigned female sex at birth and is a participant of nonchildbearing potential (PONCBP) defined as one of the following: * Premenarchal * Premenopausal with documented hysterectomy and/or bilateral salpingectomy * Postmenopausal * Medical cause of permanent infertility (eg, Müllerian agenesis, androgen insensitivity) Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of opportunistic infection (eg, invasive candidiasis or pneumocystis pneumonia) * Has had a serious local infection (eg, cellulitis, abscess) or systemic infection (eg, septicemia) within 3 months prior to screening

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As listed by the trial registrant

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

Healthy

Contacts and locations

Locations

  • Advanced Pharma CR, LLC ( Site 0005)

    Miami, Florida, 33147, United States

  • Anaheim Clinical Trials ( Site 0007)

    Anaheim, California, 92801, United States

  • Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)

    Springfield, Missouri, 65802, United States

  • QPS-MRA, LLC ( Site 0004)

    South Miami, Florida, 33143, United States

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