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A Clinical Study of Sotatercept (MK-7962) in People With Combined Postcapillary and Precapillary Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (MK-7962-041) (CHORUS)

2026年10月21日 更新者：Merck Sharp & Dohme LLC

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Sotatercept in Adults With Combined Postcapillary and Precapillary Pulmonary Hypertension (CpcPH) and Heart Failure With Preserved Ejection Fraction (HFpEF)

Researchers are looking for other ways to treat people with combined postcapillary and precapillary pulmonary hypertension (CpcPH). This trial focuses on CpcPH that is related to heart failure with preserved ejection fraction (HFpEF). The goal of the study is to learn if participants who receive sotatercept live longer without their CpcPH-HFpEF getting worse than those who receive placebo.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

Participants will have the option to continue or start treatment with sotatercept in the extension study, MK-7962-023 (NCT06814145), after completing the End of Treatment visit.

研究の種類

介入

入学 (推定)

352

段階

  • フェーズ 3

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～85年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

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

  • Has clinical diagnosis of HF with preserved ejection fraction on optimized guideline-directed medical therapy
  • Has CpcPH confirmed by right-heart catheterization
  • Has NYHA FC II or III

Exclusion Criteria:

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

  • Has a diagnosis of PH in World Health Organization Group 1, 3, 4, or 5

  • Has CV comorbidities:

    • History of surgical or transcatheter correction of mitral or aortic stenosis or regurgitation within 12 months before Screening
    • More than one valve replacement or repair (mechanical or bioprosthetic), or anticipated valve replacement or repair during the study
    • History of serious, life-threatening, or hemodynamically significant arrhythmia, long corrected QT interval syndrome, or Brugada syndrome
    • History of hypertrophic cardiomyopathy, infiltrative cardiomyopathy (including, but not limited to, cardiac amyloidosis), dilated cardiomyopathy, arrhythmogenic ventricular cardiomyopathy, or restrictive cardiomyopathy

  • History or evidence of chronic liver disease

  • Has a current diagnosis of end-stage renal disease

  • History of organ transplantation (except corneal transplant) or bone marrow transplantation ≤5 years before Screening or has a life expectancy of <12 months

  • History of malignancy ≤5 years before Screening, with the exception of fully excised or treated basal cell carcinoma, cervical carcinoma in situ, or ≤2 squamous cell carcinomas of the skin

  • Has any noncardiopulmonary condition or acute/chronic impairment(s) (other than dyspnea) that limits their ability to perform the 6-minute walk test

  • Has moderate or severe obstructive sleep apnea

  • Has a body mass index ≥50 kg/m^2

  • Has been treated with any approved pulmonary arterial hypertension-specific medications within 30 days of Randomization

  • Has background medication with the following agents: sodium-glucose cotransporter-2 inhibitor, renin-angiotensin-aldosterone system inhibitors, mineralocorticoid receptor antagonists, diuretics, and beta-blockers, that is not a stable dose for ≥30 days before Randomization

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：4倍

武器と介入

参加者グループ / アーム
介入・治療
実験的：Sotatercept

Participants will receive sotatercept 0.3 mg/kg via subcutaneous (SC) injection every 3 weeks until end of study (up to approximately 37 months).
生物学的：Sotatercept

SC injection administered every 3 weeks.

他の名前：
  • エース-011
  • MK-7962
  • WINREVAIR™
プラセボコンパレーター：Placebo

Participants will receive matching placebo via SC injection every 3 weeks until end of study (up to approximately 37 months).
生物学的：Placebo

SC injection administered every 3 weeks.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Time to Clinical Worsening (TTCW)
時間枠：Up to ~37 months

TTCW was defined as time to first occurrence of any of the following events: cardiovascular (CV) death, hospitalization due to worsening heart failure (HF) or pulmonary hypertension (PH), urgent visits due to worsening HF or PH, or deterioration in exercise capacity (≥15% decrease from baseline in 6-minute walk distance [6MWD], confirmed by 2 tests) due to worsening HF or PH. CV deaths are defined as any deaths with a primary CV cause, including acute myocardial infarction (MI), sudden cardiac death, HF, PH worsening, stroke, and other CV causes.
Up to ~37 months

二次結果の測定

結果測定
メジャーの説明
時間枠
Time to First Event of CV Death, Hospitalization Due to Worsening HF or PH, or Urgent Visit Due to Worsening HF or PH
時間枠：Up to ~37 months

CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to first event of CV death, hospitalization due to worsening HF or PH, or urgent visit due to worsening HF or PH will be presented.
Up to ~37 months
Time to First Event of CV Death or Hospitalization Due to Worsening HF or PH
時間枠：Up to ~37 months

CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to first event of CV death or hospitalization due to worsening HF or PH will be presented.
Up to ~37 months
Change From Baseline in 6MWD at Week 24
時間枠：Baseline and Week 24

The 6MWD tests the distance walked in 6 minutes as an assessment of exercise capacity. The baseline value for 6MWD is the average of the 2 values collected during Screening. The change from baseline in 6MWD at Week 24 will be presented.
Baseline and Week 24
Time to the Date of Death Due to Any Cause
時間枠：Up to ~37 months

The time to date of death (all causes) will be presented.
Up to ~37 months
Time to First Hospitalization Due to Worsening HF or PH
時間枠：Up to ~37 months

The time to first hospitalization due to worsening HF or PH will be presented.
Up to ~37 months
Time to First Urgent Visit Due to Worsening HF or PH
時間枠：Up to ~37 months

The time to first urgent visit due to worsening HF or PH will be presented.
Up to ~37 months
Percentage of Participants Maintaining and/or Improving New York Heart Association (NYHA) Functional Class (FC) at Week 24
時間枠：Week 24

NYHA FC classifies the extent of heart failure. The percentage of participants maintaining and/or improving NYHA FC at Week 24 will be presented.
Week 24
Change From Baseline in N-Terminal Pro-B-type Natriuretic Peptide (NT-proBNP) Levels at Week 24
時間枠：Baseline and Week 24

NT-proBNP is a circulating biomarker that reflects myocardial stretch. The change from baseline in NT-proBNP levels at Week 24 will be presented.
Baseline and Week 24
Number of Participants Who Experience One or More Adverse Events (AEs)
時間枠：Up to ~37 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be presented.
Up to ~37 months
Number of Participants Who Discontinue Study Intervention Due to an AE
時間枠：Up to ~37 months

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be presented.
Up to ~37 months
Time to CV Death
時間枠：Up to ~37 months

CV deaths are defined as any deaths with a primary CV cause, including acute MI, sudden cardiac death, HF, PH worsening, stroke, and other CV causes. The time to CV death will be presented.
Up to ~37 months

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Merck Sharp & Dohme LLC

捜査官

  • スタディディレクター：Medical Director、Merck Sharp & Dohme LLC

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

便利なリンク

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年11月26日

一次修了 (推定)

2030年1月8日

研究の完了 (推定)

2030年6月14日

試験登録日

最初に提出

2026年9月18日

QC基準を満たした最初の提出物

2026年9月18日

最初の投稿 (実際)

2026年9月24日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月23日

QC基準を満たした最後の更新が送信されました

2026年10月21日

最終確認日

2026年10月1日

詳しくは

本研究に関する用語

追加の関連 MeSH 用語

その他の研究ID番号

  • 7962-041
  • 2025 (米国 NIH グラント/契約)
  • MK-7962-041 (その他の識別子：MSD)
  • 2025-524634-25-00 (レジストリ識別子：EU CT)
  • U1111-1331-4324 (レジストリ識別子：UTN)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

はい

米国FDA規制機器製品の研究

いいえ

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