Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity
2026年8月26日 更新者：Xiao Wang、China National Center for Cardiovascular Diseases
Effect of Mazdutide on Coronary Plaque Progression in Patients With Coronary Atherosclerosis and Overweight or Obesity: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the effect of mazdutide, a dual GLP-1/GCG receptor agonist, on coronary plaque progression assessed by coronary computed tomography angiography (CCTA) in patients with coronary atherosclerosis and overweight or obesity.
The primary endpoint is the change in total non-calcified plaque volume (NCPV) from baseline to week 52.
Secondary endpoints include changes in pericoronary adipose tissue inflammation (fat attenuation index, FAI), plaque composition, metabolic parameters, inflammatory biomarkers, and clinical outcomes.
A substudy will include 18F-NaF PET/CT imaging.
調査の概要
詳細な説明
Coronary atherosclerosis is the principal pathological substrate underlying most cardiovascular events and remains a leading cause of morbidity and mortality. Overweight and obesity are well-established independent risk factors that drive the development and progression of coronary atherosclerotic plaque, and thus represent critical modifiable targets for therapeutic intervention.
Prior studies have shown that GLP-1 receptor agonists (GLP-1RAs) provide hypoglycemic, weight-loss, and cardiovascular protective benefits. Mazdutide, the first approved GLP-1/GCG dual receptor agonist, combines GLP-1-mediated insulin secretion and appetite suppression with GCG-driven energy expenditure. Phase III trials have demonstrated robust glycemic and weight benefits, along with reductions in hs-CRP and liver fat. Given that dual-receptor activation yields more robust metabolic improvements than single-receptor agonism, mazdutide may possess greater potential than GLP-1 monotherapy in suppressing coronary plaque progression.
Therefore, we propose a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the effect of 52 weeks of Mazdutide treatment on CCTA-assessed non-calcified plaque volume (NCPV) in patients with coronary atherosclerosis and overweight or obesity.
PET-CT substudy: A subset of eligible patients will be enrolled into a sub-study, we aim to evaluate the efficacy of Mazdutide on plaque inflammation assessed by 18F-NaF PET/CT.
研究の種類
介入
入学 (推定)
116
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
- 名前：Xiao Wang
- 電話番号：86-10-88396953
- メール：wangxiao@fuwai.com
研究連絡先のバックアップ
- 名前：Fang Luo
- 電話番号：86-10-88396953
- メール：luofang@fuwaihospital.org
研究場所
-
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Beijing Municipality
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Beijing、Beijing Municipality、中国、100037
- Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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主任研究者：
- Kefei Dou, MD
-
コンタクト：
- Xiao Wang, MD
- 電話番号：86-10-88396953
- メール：wangxiao@fuwai.com
-
主任研究者：
- Xiao Wang, MD
-
コンタクト：
- Luo Fang
- 電話番号：86-10-88396953
- メール：luofang@fuwaihospital.org
-
-
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
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age ≥ 18 years
- BMI ≥ 28 kg/m2 or BMI≥ 24kg/m2 with at least one of the following conditions: dyslipidemia, metabolic associated fatty liver disease, hypertension, prediabetes, type 2 diabetes mellitus, or obesity-related obstructive sleep apnea syndrome (at screening or within 6 months prior to screening).
- Coronary stenosis 30-70% confirmed by CAG or CCTA within 3 months prior to enrollment.
- Signed informed consent
- Willing to comply with follow-up
Exclusion Criteria:
History or evidence of the following :
- A history of severe hypoglycemia, or recurrent symptomatic hypoglycemia (≥2 episodes) within the past six months
- Severe heart disease as determined by the investigator, including coronary artery disease that has undergone or is planned for coronary artery bypass grafting or percutaneous coronary intervention, valvular heart disease requiring valve repair or replacement, heart transplantation, severe heart failure (NYHA III-IV) or cardiogenic shock, or a known history of left ventricular ejection fraction ≤30%
- A hemorrhagic/ischemic stroke or transient ischemic attack within six months prior to screening
- A history of acute or chronic pancreatitis, gallbladder/bile duct disease, or pancreatic injury
- Presence of severe diseases such as malignant tumors, lymphoma, liver cirrhosis, HIV-positive status, etc., with an expected survival of less than 2 years
- Contraindications to GLP-1/GCG dual receptor agonists, such as hypersensitivity or severe intolerance
- A personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
Use of the following medications or treatments prior to screening :
- Use of weight-affecting medications (e.g., systemic steroids, tricyclic antidepressants, psychiatric/sedative medications, etc.) within three months prior to screening
- Use of GLP-1 RA or GIP/GLP-1 RA (exposure to investigational drugs) within three months prior to screening
- Participation in other clinical trials (exposure to investigational drugs) within three months prior to screening
- Known clinically significant abnormal gastric emptying or current use of medications that directly affect gastrointestinal motility
Laboratory test results meeting any of the following criteria at screening (repeat testing within one week is permitted if there is a clear reason, and the reason for retesting must be documented by the investigator)
- Serum calcitonin ≥50 ng/L (pg/mL)
- ALT/AST >3.0 × ULN
- eGFR <30 mL/min/1.73m²
- Abnormal thyroid function (TSH >6 mIU/L or <0.4 mIU/L)
- Pregnancy, planned pregnancy, or breastfeeding
- Contraindications to CCTA, including severe allergy to iodine contrast agents, presence of cardiac implantable electronic devices or other metal implants that may affect image analysis
- Inability to complete the study or comply with study requirements as determined by the investigator Exclusion criteria for the PET-CT substudy: All exclusion criteria of the main study, as well as contraindications to PET-CT examination
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：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：プラセボ
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Placebo administered subcutaneously once weekly, starting at 2 mg for 4 weeks, then escalated to 4 mg for 4 weeks, and then to 6 mg thereafter until week 52.
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実験的：Experimental: Mazdutide
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Mazdutide administered subcutaneously once weekly, starting at 2 mg for 4 weeks, then escalated to 4 mg for 4 weeks, and then to 6 mg thereafter until week 52.
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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 |
時間枠 |
|---|---|
|
Change in total non-calcified plaque volume (NCPV) by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Change in RCA pericoronary fat attenuation index (RCA-FAI) by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in LAD pericoronary fat attenuation index (LAD-FAI) by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in LCX pericoronary fat attenuation index (LCX-FAI) by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in lesion pericoronary fat attenuation index (lesion-FAI) by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in total plaque volume (TPV) by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in percent atheroma volume (PAV) by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in low-attenuation plaque volumes by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
|
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Change in fibrous plaque volumes by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in fibrofatty plaque volumes by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in calcified plaque volumes by CCTA from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in total cholesterol from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in triglycerides from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
|
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Change in LDL-C from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
|
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Change in non-HDL-C from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in ApoB from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in HbA1c from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Changein fasting glucose from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in uric acid from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in Lp(a) from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in hs-CRP from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in IL-6 from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in TNF-α from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in body weight from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in waist circumference from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in waist-to-hip ratio from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in SBP from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Change in DBP from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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Incidence of major adverse cardiovascular events (MACE) at 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
|
Change in liver stiffness measurement by vibration-controlled transient elastography from baseline to 52 weeks
時間枠：Baseline and 52 weeks
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Baseline and 52 weeks
|
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Change in controlled attenuation parameter by vibration-controlled transient elastography from baseline to 52 weeks
時間枠：Baseline and 52 weeks
|
Baseline and 52 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。
捜査官
- 主任研究者：Xiao Wang、Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
- 主任研究者：Ke fei Dou、Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College
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9月1日
一次修了 (推定)
2027年12月31日
研究の完了 (推定)
2027年12月31日
試験登録日
最初に提出
2026年6月14日
QC基準を満たした最初の提出物
2026年6月14日
最初の投稿 (実際)
2026年6月18日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月28日
QC基準を満たした最後の更新が送信されました
2026年8月26日
最終確認日
2026年8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
- 2026-3068
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