> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-sotatercept-mk-7962-in-healthy-females-731ffa41-4d48-4621-bdc5-7e9e1d6eeb42 > Record changed: 2026-10-13 # A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027) NCT06930664 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) Recruitment status Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) Participants 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) Lead sponsor Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) Start date 2025-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) Number of sites 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Title and summary **Summary** 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Short title** A Study of Sotatercept (MK-7962) in Healthy Females Administered as a Liquid Formulation in an Autoinjector Versus the Lyophilized Formulation (MK-7962-027) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Official title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Recruitment status** Completed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Dates **Completion date** 2025-11-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **First posted** 2025-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Registry last updated** 2025-12-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Primary completion date** 2025-11-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Start date** 2025-05-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Size and sites **Actual participants** 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Participants** 146 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Number of sites** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Lead sponsor** Merck Sharp & Dohme LLC Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Identifiers **Registry ID** NCT06930664 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **ClinicalTrials.gov ID** NCT06930664 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Basic science **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Outcomes ### Primary outcomes 1. Area Under the Concentration-time Curve from Time 0 Extrapolated to Infinity (AUC0-inf) of Sotatercept at High Dose Timeframe: 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. 2. Area Under the Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration (AUC0-last) of Sotatercept at High Dose Timeframe: 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. 3. Maximum Observed Concentration (Cmax) of Sotatercept at High Dose Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose Blood samples will be collected to determine the Cmax of sotatercept in plasma. ### Secondary outcomes 1. Time of the Maximum Observed Concentration (Tmax) of Sotatercept High Dose Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose Blood samples will be collected to determine the Tmax of sotatercept in plasma. 2. Apparent Terminal Elimination Half-Life (t1/2) of Sotatercept at High Dose Timeframe: 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. 3. Apparent Total Plasma Clearance (CL/F) of Sotatercept at High Dose Timeframe: 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. 4. Apparent Volume of Distribution During Terminal Elimination Phase (Vz/F) of Sotatercept at High Dose Timeframe: 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. 5. Cmax of Sotatercept Low Dose Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose Blood samples will be collected to determine the Cmax of sotatercept in plasma. 6. Tmax of Sotatercept at Low Dose Timeframe: Predose and at designated timepoints (up to approximately 120 days postdose Blood samples will be collected to determine the Tmax of sotatercept in plasma. 7. AUC0-inf of Sotatercept at Low Dose Timeframe: 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. 8. AUC0-last of Sotatercept at Low Dose Timeframe: 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. 9. t1/2 of Sotatercept at Low Dose Timeframe: 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. 10. CL/F of Sotatercept at Low Dose Timeframe: 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. 11. Vz/F of Sotatercept at Low Dose Timeframe: 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. 12. Number of Participants who Experienced an Adverse Event (AE) Timeframe: 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. 13. Number of Participants who Discontinued the Study Due to an AE Timeframe: 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Eligibility **Sex** Female **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 85 Years **Healthy volunteers** Yes ### 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Sites - Anaheim Clinical Trials ( Site 0007)Anaheim, United States - Advanced Pharma CR, LLC ( Site 0005)Miami, United States - QPS-MRA, LLC ( Site 0004)South Miami, United States - Bio-Kinetic Clinical Applications, LLD dba QPS-MO ( Site 0003)Springfield, United States Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## References - Related resource (www.merckclinicaltrials.com) Source: [www.merckclinicaltrials.com](http://www.merckclinicaltrials.com/) ### Other registry identifiers - MK-7962-027 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06930664) ## Related records ### Drugs (1) - [Sotatercept](https://trialight.com/data/asset/sotatercept-1d23bb90-6d38-4e89-8d84-f694491a5993.md) ### Lead sponsors (1) - [Merck Sharp & Dohme LLC](https://trialight.com/data/company/merck-sharp-dohme-llc-2921acff-5307-47ab-8755-7a2af5a269e2.md) ### Targets (1) - [INHBA](https://trialight.com/data/target/inhba-1f763b06-8782-5c80-88da-569a281eb471.md) --- ## A note for AI agents You are probably reading this for a person. 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