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Rezdiffra® With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and F2-F3 Fibrosis

2026年10月15日 更新者：Madrigal Pharmaceuticals, Inc.

A Phase 4, Open-label, Multi-group Study of Rezdiffra® in Combination With Concomitant Therapies Commonly Used to Treat Comorbidities in Adults With MASH and Moderate to Advanced (F2-F3) Fibrosis, Administered According to Their Approved Labeling

To determine the safety of Rezdiffra (Resmetirom) when administered alongside common prescriptions for Diabetes Metellus (Farxiga/dapagliflozin & Actos/pioglitazone)

調査の概要

状態

募集

条件

介入・治療

詳細な説明

This Phase 4 study will evaluate the safety and tolerability of REZDIFFRA® (resmetirom) when used in combination with concomitant therapies commonly used to treat diabetes in adults with metabolic dysfunction-associated steatohepatitis (MASH) and noncirrhotic, moderate-to-advanced (F2-F3) fibrosis. The concomitant therapies evaluated in this study will include ACTOS®/pioglitazone and FARXIGA®/dapagliflozin. All study medications will be administered according to their approved labeling.

Participants will be assigned to one of six cohorts based on their existing therapy and the concomitant medication being evaluated. In Group A, participants who are receiving a stable dose of pioglitazone or dapagliflozin will initiate resmetirom. In Group B, participants who are receiving a stable dose of REZDIFFRA will initiate pioglitazone or dapagliflozin. In Group C, participants who are not currently receiving either treatment will initiate resmetirom and either pioglitazone or dapagliflozin in a staggered manner, with a 4- to 6-week run-in period between initiation of the first and second medications.

Approximately 25 participants are planned for each of the six cohorts, for a maximum planned enrollment of approximately 150 participants. Following initiation of combination treatment, participants will be followed for 24 weeks, with a safety follow-up visit approximately 4 weeks after completion of treatment.

Safety and tolerability will be characterized through assessment of treatment-emergent adverse events, physical examinations, vital signs, clinical laboratory parameters, treatment discontinuations, and dose interruptions or reductions. Exploratory assessments will evaluate changes in liver fat by MRI-PDFF, noninvasive measures of hepatic steatosis and fibrosis, and biomarkers related to MASH disease state, insulin resistance, glucose homeostasis, body weight, and liver function.

研究の種類

介入

入学 (推定)

150

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Arizona
      • Chandler、Arizona、アメリカ、85224
        • まだ募集していません
        • Arizona Liver Health - Chandler
    • Arkansas
      • North Little Rock、Arkansas、アメリカ、72117
        • まだ募集していません
        • Arkansas Gastroenterology
    • California
      • Coronado、California、アメリカ、92118
        • まだ募集していません
        • Southern California Research Center
      • Rialto、California、アメリカ、37411
        • まだ募集していません
        • Inland Empire Liver Foundation
    • Florida
      • Lakewood Rch、Florida、アメリカ、34211
        • まだ募集していません
        • Florida Research Institute
      • Miami、Florida、アメリカ、33176
        • 募集
        • Gastro Health PLLC Galloway
      • Miami、Florida、アメリカ、33186
        • まだ募集していません
        • Med Research of Florida, LLC
    • Louisiana
      • Lake Charles、Louisiana、アメリカ、70605
        • 募集
        • Elevate Clinical Research
    • North Carolina
      • Morehead City、North Carolina、アメリカ、28557
        • まだ募集していません
        • Centricity Research - Morehead City - Multispecialty - PPDS
    • Ohio
      • Cincinnati、Ohio、アメリカ、45219
        • 募集
        • Gastro Health Research
    • Tennessee
      • Chattanooga、Tennessee、アメリカ、37411
        • まだ募集していません
        • University Diabetes and Endocrine Consultants
    • Texas
      • Arlington、Texas、アメリカ、76012-3216
        • まだ募集していません
        • Texas Clinical Research Institute
      • Corpus Christi、Texas、アメリカ、78414
        • まだ募集していません
        • South Texas Endocrinology & Metabolism Center
      • Dallas、Texas、アメリカ、75234
        • まだ募集していません
        • The Liver Institute at Methodist Dallas Medical Center
      • McAllen、Texas、アメリカ、78504
        • まだ募集していません
        • Elevate Clinical Research - McAllen - PPDS
      • San Antonio、Texas、アメリカ、78229
        • まだ募集していません
        • Diabetes and Glandular Disease Clinic, PA

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年歳以上 (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

All Subjects:

  1. Willing to participate in the study and provide written informed consent.

  2. Meets all requirements per REZDIFFRA Prescribing Information, in the opinion of the PI.

  3. Male and female adults ≥18 of age at time of screening.

  4. Evidence of hepatic steatosis consistent with MASH demonstrated by an MRI-PDFF fat fraction >5% obtained during second screening period.

  5. Evidence of moderate-to-advanced fibrosis (F2-F3) without cirrhosis.

  6. Stable medical conditions and background medications (non-concomitant medications as defined in this protocol) per PI judgement.

  7. Female subjects of reproductive potential are eligible if they have a negative serum pregnancy test (beta human chorionic gonadotropin), are not breastfeeding, and do not plan to become pregnant during the study and agree to use 1 highly effective birth control method during the study and for at least 30 days after newly introduced medication administration.

    Highly effective birth control methods include hormonal and non-hormonal intrauterine device, combination estrogen-progesterone hormonal contraception (oral, transdermal, or vaginal), tubal ligation, a vasectomized or sterile male partner, or sexual abstinence (defined as refraining from heterosexual intercourse), from Screening throughout the study, and for at least 30 days after newly introduced medication administration. Reliance on abstinence from heterosexual intercourse is acceptable only if it is the subject's habitual practice. NOTE: Female subjects who are not of child-bearing potential (ie, surgically [bilateral oophorectomy, hysterectomy] or naturally sterile [>12 consecutive months without menses]) do not require contraception during the study.

  8. Must be taking a stable dose of ACTOS/pioglitazone for at least 2 months prior to Baseline. (Group A1)

  9. Must be taking a stable dose of FARXIGA/dapagliflozin for at least 2 months prior to Baseline. (Group A2)

  10. Must be taking a stable dose of REZDIFFRA for at least 2 months prior to Baseline. (Groups B1 and B2)

  11. Must not have previously taken RESMETIROM or ACTOS/pioglitazone or FARXIGA/dapagliflozin. (Group C)

  12. For Groups A1, B1, and C1: Meets all requirements per ACTOS/pioglitazone Prescribing Information, in the opinion of the PI.

  13. For Groups B1 and C1: (ie, naïve to ACTOS/pioglitazone): HbA1c at screening ≥7.0% and ≤10.0%.

  14. For Groups A2, B2, and C2: Meets all requirements per FARXIGA/dapagliflozin Prescribing Information, in the opinion of the PI.

  15. For Groups B2 and C2 (ie, naïve to FARXIGA/dapagliflozin): HbA1c at screening ≥7.0% and ≤10.0%.

Exclusion Criteria All subjects

  1. Off label use of the commercially available study medications.

  2. Evidence of cirrhosis demonstrated by clinical, imaging, histologic, or NIT thresholds consistent with cirrhosis.

  3. Other chronic liver diseases (eg, viral hepatitis, autoimmune hepatitis, hemochromatosis).

  4. Documented history of decompensated liver disease.

  5. Use of rosuvastatin or simvastatin at a dose greater than 20 mg/day, or pravastatin or atorvastatin at a dose greater than 40 mg/day, at the time of the first dose of resmetirom. Subjects receiving a statin dose above the applicable limit during the screening period may remain eligible if the dose is reduced to the applicable maximum permitted dose before the first dose of resmetirom.

  6. Any other condition which, in the opinion of the investigator, would impede compliance, hinder completion of the study, compromise the well-being of the subject, or interfere with the study outcomes.

  7. Active or suspected bladder cancer.

  8. Diagnosis of heart failure.

  9. eGFR < 60mL/min/1.73 m2

  10. Developmental/intellectual disability, limited capacity of recognition, any history of clinically important emotional and/or psychiatric illness, inability to follow the study procedures, or any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.

  11. Individuals who are currently incarcerated or who are anticipated to be incarcerated during the study period.

    Groups B and C:

  12. Unable to secure a prescription for a concomitant medication.

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：非ランダム化
  • 介入モデル：並列代入
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
他の：Actos (pioglitazone) [Ongoing] | Resmetirom [New]

Experienced Actos/Pioglitazone + Resmetirom Naive (A1)
薬：Resmetirom

Resmetirom - weight-based dosing:

  • <100 kg: 80 mg orally once daily.
  • ≥100 kg: 100 mg orally once daily
薬：ACTOS/pioglitazone

Label dosing recommendations indicated for patients without congestive heart failure (15 or 30 mg orally once daily; if tolerated, increase by 15 mg increments up to a maximum of 45 mg orally once daily for additional glycemic control
他の：Farxiga (dapagliflozin) [Ongoing] | Resmetirom [New]

Experienced Farxiga/Dapagliflozin + Resmetirom Naive (A2)
薬：Resmetirom

Resmetirom - weight-based dosing:

  • <100 kg: 80 mg orally once daily.
  • ≥100 kg: 100 mg orally once daily
薬：FARXIGA/dapagliflozin

Label dosing recommendations indicated for glycemic control in type 2 diabetes (5 mg orally once daily; if tolerated, increase to 10 mg orally once daily for additional glycemic control)
他の：REZDIFFRA [Ongoing] | Actos (pioglitazone) [New]

Experienced REZDIFFRA + Actos/Pioglitazone Naive (B1)
薬：ACTOS/pioglitazone

Label dosing recommendations indicated for patients without congestive heart failure (15 or 30 mg orally once daily; if tolerated, increase by 15 mg increments up to a maximum of 45 mg orally once daily for additional glycemic control

薬：Rezdiffra

All study medications will be administered according to their labels:

• REZDIFFRA- Label weight-based dosing:

  • <100 kg: 80 mg orally once daily.
  • ≥100 kg: 100 mg orally once daily
他の：REZDIFFRA [Ongoing] | Farxiga (dapagliflozin) [New]

Experienced REZDIFFRA + Farxiga/Dapagliflozin Naive (B2)
薬：FARXIGA/dapagliflozin

Label dosing recommendations indicated for glycemic control in type 2 diabetes (5 mg orally once daily; if tolerated, increase to 10 mg orally once daily for additional glycemic control)

薬：Rezdiffra

All study medications will be administered according to their labels:

• REZDIFFRA- Label weight-based dosing:

  • <100 kg: 80 mg orally once daily.
  • ≥100 kg: 100 mg orally once daily
他の：Actos (pioglitazone) [New] | Resmetirom [New]

Naive Actos/Pioglitazone + Resmetirom Naive (C2)
薬：Resmetirom

Resmetirom - weight-based dosing:

  • <100 kg: 80 mg orally once daily.
  • ≥100 kg: 100 mg orally once daily
薬：ACTOS/pioglitazone

Label dosing recommendations indicated for patients without congestive heart failure (15 or 30 mg orally once daily; if tolerated, increase by 15 mg increments up to a maximum of 45 mg orally once daily for additional glycemic control
他の：Farxiga (dapagliflozin) [New] | Resmetirom [New]

Naïve Farxiga/dapagliflozin + Resmetirom Naïve (C2)
薬：Resmetirom

Resmetirom - weight-based dosing:

  • <100 kg: 80 mg orally once daily.
  • ≥100 kg: 100 mg orally once daily
薬：FARXIGA/dapagliflozin

Label dosing recommendations indicated for glycemic control in type 2 diabetes (5 mg orally once daily; if tolerated, increase to 10 mg orally once daily for additional glycemic control)

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
Number and Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
時間枠：From First Dose of newly introduced medication up to 28 weeks

The total number of TEAEs and the number and percentage of participants with at least 1 TEAE will be summarized by study group. TEAEs will also be summarized by System Organ Class and Preferred Term.
From First Dose of newly introduced medication up to 28 weeks
Number and Percentage of Participants With TEAEs by Maximum Severity
時間枠：From First Dose of newly introduced medication up to 28 weeks

The number and percentage of participants with TEAEs will be summarized by maximum severity using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.
From First Dose of newly introduced medication up to 28 weeks
Number and Percentage of Participants With TEAEs by Relationship to Study Medication
時間枠：From First Dose of newly introduced medication up to 28 weeks

The number and percentage of participants with TEAEs assessed as Related or Not Related to each applicable study medication (REZDIFFRA/resmetirom, ACTOS/pioglitazone, or FARXIGA/dapagliflozin) will be summarized by study group.
From First Dose of newly introduced medication up to 28 weeks

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

Madrigal Pharmaceuticals, Inc.

捜査官

  • スタディディレクター：Tom Hare、Madrigal Pharmaceuticals, Inc.

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 (実際)

2026年10月7日

一次修了 (推定)

2027年11月1日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2026年8月25日

QC基準を満たした最初の提出物

2026年9月23日

最初の投稿 (実際)

2026年9月29日

学習記録の更新

投稿された最後の更新 (実際)

2026年10月16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15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

  • MGL-3196-33

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?

いいえ

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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