A Phase 2, Multicenter, Double-blind, Extension Study to Evaluate the Effects of Sotatercept for the Treatment of Combined Postcapillary and Precapillary Pulmonary Hypertension (Cpc-PH) Due to Heart Failure With Preserved Ejection Fraction (HFpEF)

Extension study of sotatercept for pulmonary hypertension in heart failure patients

NCT: NCT06814145 · Status: RECRUITING · Phase: Phase 2 · Sponsor: Merck Sharp & Dohme LLC · Started: 2025-04-16 · Est. Completion: 2029-03-30

Plain English Summary

Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023) is a Phase 2 clinical trial sponsored by Merck Sharp & Dohme LLC studying Hypertension, Pulmonary. This study tests sotatercept, a new drug, in people who have already participated in a sotatercept study for a specific type of lung and heart condition. It is for adults with combined postcapillary and precapillary pulmonary hypertension (Cpc-PH) caused by heart failure with preserved ejection fraction (HFpEF). Participants will receive sotatercept as an injection and be monitored for a longer period. Alternative treatments may include standard medical therapies for heart failure and pulmonary hypertension. The trial aims to enroll 130 participants.

Official Summary

Researchers are looking for new ways to treat people with a type of pulmonary hypertension called combined postcapillary and precapillary pulmonary hypertension (Cpc-PH). This study focuses on Cpc-PH that is caused by heart failure with preserved ejection fraction (HFpEF). Researchers want to know if the study treatment, sotatercept, can treat people with Cpc-PH caused by HFpEF. This is an extension study, which means people who took part in a certain study on sotatercept for Cpc-PH (called a parent study) may be able to join this study. In this extension study, people will take sotatercept and researchers will follow their health for a longer time. The main goal of this extension study is to learn about the long-term safety of sotatercept and if people tolerate it over a longer period of time.

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you completed a previous sotatercept study (MK-7962-007) and are able to safely enroll in this one. You cannot join if you have other specific types of pulmonary hypertension (WHO Groups 1, 3, 4, or 5). You cannot join if you are pregnant or breastfeeding, have severe liver problems, or have had or anticipate significant heart valve surgery or transplant. You also cannot join if you have had a previous exposure to a similar drug called luspatercept. This trial is studying Hypertension, Pulmonary, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcomes focus on how safe the drug is over an extended period by tracking any side effects and if participants need to stop the treatment due to them. The specific primary outcome measures are: Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 187 weeks); Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 168 weeks). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial matters because it aims to provide a longer-term safety and tolerability assessment of sotatercept, a potential new treatment for a complex form of pulmonary hypertension linked to heart fa Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Hypertension, Pulmonary, where improved treatment options are needed.

Investor Insight

This is an extension study for a drug targeting a specific unmet need in pulmonary hypertension, suggesting potential for a new therapeutic option if long-term safety and efficacy are confirmed. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific risks and benefits of continuing sotatercept treatment. Understand how often you will need to receive injections and attend follow-up appointments. Be prepared for regular monitoring of your health and potential side effects. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

\- Completed MK-7962-007 (CADENCE) (Visit 9 and end of treatment \[EOT\] visit) without discontinuing study intervention and is able to safely enroll into MK-7962-007 (HARMONIZE)

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a diagnosis of pulmonary hypertension (PH) in world health organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5
* Has had a study intervention interruption
* Is pregnant or breastfeeding
* Has chronic liver disease with severe hepatic impairment and/or cirrhosis (eg, hepatic encephalopathy)
* Anticipation of more than 1 valve replacement or repair (mechanical or biomechanical) and/or have undergone more than 1 valve replacement or repair
* Has severe tricuspid regurgitation due to primary valvular disease (eg, from endocarditis, carcinoid, or mechanical destruction)
* Anticipated or undergone heart transplant or ventricular assist device implantation
* Has had prior exposure to luspatercept

Trial Locations

Frequently Asked Questions

What is clinical trial NCT06814145?

NCT06814145 is a Phase 2 INTERVENTIONAL study titled "Extension Study of Sotatercept in People With Pulmonary Hypertension (MK-7962-023)." It is currently recruiting and is sponsored by Merck Sharp & Dohme LLC. The trial targets enrollment of 130 participants.

What conditions does NCT06814145 study?

This trial investigates treatments for Hypertension, Pulmonary. The primary condition under study is Hypertension, Pulmonary.

What treatments are being tested in NCT06814145?

The interventions being studied include: Sotatercept (BIOLOGICAL). subcutaneous injection

What does Phase 2 mean for NCT06814145?

Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.

What is the current status of NCT06814145?

This trial is currently "Recruiting." It started on 2025-04-16. The estimated completion date is 2029-03-30.

Who is sponsoring NCT06814145?

NCT06814145 is sponsored by Merck Sharp & Dohme LLC. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT06814145?

The trial aims to enroll 130 participants. The trial is currently recruiting and accepting new participants.

How is NCT06814145 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs triple masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.

What are the primary outcomes being measured in NCT06814145?

The primary outcome measures are: Number of Participants Who Experience an Adverse Event (AE) (Up to approximately 187 weeks); Number of Participants Who Discontinue Study Treatment Due to an AE (Up to approximately 168 weeks). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT06814145 being conducted?

This trial is being conducted at 20 sites, including Phoenix, Arizona; Santa Barbara, California; Stanford, California; Littleton, Colorado and 16 more sites (United States).

Where can I find official information about NCT06814145?

The official record for NCT06814145 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06814145. This government database provides the most up-to-date and detailed information about the trial.

What is NCT06814145 testing in simple terms?

This study tests sotatercept, a new drug, in people who have already participated in a sotatercept study for a specific type of lung and heart condition. It is for adults with combined postcapillary and precapillary pulmonary hypertension (Cpc-PH) caused by heart failure with preserved ejection fraction (HFpEF).

Why is this trial significant?

This trial matters because it aims to provide a longer-term safety and tolerability assessment of sotatercept, a potential new treatment for a complex form of pulmonary hypertension linked to heart fa

What are the potential risks of participating in NCT06814145?

The main risks involve potential side effects from sotatercept, which will be closely monitored. These could include various adverse events that might require stopping the study drug. Specific risks mentioned in exclusion criteria include severe liver disease and significant heart conditions. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT06814145?

Ask your doctor about the specific risks and benefits of continuing sotatercept treatment. Understand how often you will need to receive injections and attend follow-up appointments. Be prepared for regular monitoring of your health and potential side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT06814145 signal from an investment perspective?

This is an extension study for a drug targeting a specific unmet need in pulmonary hypertension, suggesting potential for a new therapeutic option if long-term safety and efficacy are confirmed. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.

What happens if the treatment in this trial doesn't work?

Participants will receive sotatercept as an injection and be monitored for a longer period. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.