A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027)

December 11, 2025 updated by: Merck Sharp & Dohme LLC

A Phase 1 Clinical Study in Healthy Females of Nonchildbearing Potential to Compare the Pharmacokinetics of Sotatercept (MK-7962) Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation

The goal of the study is to learn what happens to different forms of sotatercept medications in a healthy person's body over time. Researchers want to know if there is a difference in the healthy person's body when different forms of sotatercept medications are given.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Anaheim, California, United States, 92801
        • Anaheim Clinical Trials ( Site 0007)
    • Florida
      • Miami, Florida, United States, 33147
        • Advanced Pharma CR, LLC ( Site 0005)
      • South Miami, Florida, United States, 33143
        • QPS-MRA, LLC ( Site 0004)
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: High Dose Subcutaneous Injection
Participants will receive a single subcutaneous high dose of sotatercept administered via syringe.
Biological: Sotatercept
Subcutaneous Injection
Other Names:
  • ACE-011
  • MK-7962
  • ActRIIA-IgG1Fc
Experimental: High Dose Subcutaneous Autoinjector
Participants will receive a single subcutaneous high dose of sotatercept administered via autoinjector.
Biological: Sotatercept Autoinjector
Subcutaneous Auto Injection
Other Names:
  • ACE-011
  • MK-7962
  • ActRIIA-IgGIFc
Experimental: Low Dose Subcutaneous Autoinjector
Participants will receive a single subcutaneous low dose of sotatercept administered via autoinjector.
Biological: Sotatercept Autoinjector
Subcutaneous Auto Injection
Other Names:
  • ACE-011
  • MK-7962
  • ActRIIA-IgGIFc

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose)
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose)
Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Maximum Observed Concentration (Cmax) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Tmax of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the t1/2 of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the CL/F of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Sotatercept at High Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Vz/F of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Cmax of Sotatercept Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Cmax of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Tmax of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Tmax of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
AUC0-inf of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the AUC0-inf of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
AUC0-last of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the AUC0-last of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
t1/2 of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the t1/2 of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
CL/F of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the CL/F of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Vz/F of Sotatercept at Low Dose
Time Frame: Predose and at designated timepoints (up to approximately 120 days postdose
Blood samples will be collected to determine the Vz/F of sotatercept in plasma.
Predose and at designated timepoints (up to approximately 120 days postdose
Number of Participants who Experienced an Adverse Event (AE)
Time Frame: Up to approximately 120 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Up to approximately 120 days
Number of Participants who Discontinued the Study Due to an AE
Time Frame: Up to approximately 120 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Up to approximately 120 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Merck Sharp & Dohme LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 11, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 15, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 7962-027
  • MK-7962-027 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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