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Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

2026年4月22日 更新者：Zhiguang Zhou、Second Xiangya Hospital of Central South University

Prediabetes Reversion Through Combined Intervention and Strict Evaluation Trial: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study on the Efficacy of Chiglitazar Sodium Combined With Lifestyle Intervention in Restoring Normal Glucose Tolerance in Prediabetic Patients

This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Chiglitazar Sodium combined with lifestyle intervention for reversing prediabetes to normal glucose metabolism. Eligible participants with prediabetes will be randomized 1:1 to receive either Chiglitazar Sodium 48 mg once daily or matching placebo, both combined with standardized lifestyle intervention, for 52 weeks, followed by a 12-week observation period and optional long-term extension. The primary endpoint is the reversion rate to normal glucose metabolism at week 64. Secondary endpoints include progression to type 2 diabetes, glycemic control, lipid profile, blood pressure, UACR, HOMA-IR, HOMA-β, body weight, BMI, and waist-to-height ratio. Exploratory endpoints include inflammatory markers and long-term cardiovascular outcomes. Safety endpoints include adverse events, vital signs, ECG, and laboratory parameters.

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

Prediabetes is an intermediate state of hyperglycemia that precedes the development of type 2 diabetes. Reversing prediabetes to normal glucose metabolism represents a promising strategy for diabetes prevention. Chiglitazar Sodium is a novel PPAR pan-agonist with potential benefits on glycemic control and metabolic parameters.

This national multicenter study will be conducted across 30 sites in China. A total of 472 participants aged 18-70 years with prediabetes (according to Chinese expert consensus criteria, including IFG, IGT or IFG+IGT) and BMI 20-32 kg/m² will be enrolled.

The study consists of four phases:

Screening Period (up to 2 weeks): Assessment of eligibility including OGTT, laboratory tests, and medical history.

Double-Blind Treatment Period (52 weeks): Eligible participants are randomized 1:1 to receive either Chiglitazar Sodium 48 mg once daily or matching placebo, both combined with standardized lifestyle intervention (diet and exercise according to Chinese Diabetes Prevention Guidelines). Study visits occur at weeks 4, 12, 24, 36, and 52.

Observation Period (12 weeks, weeks 53-64): Participants who have not developed diabetes enter a 12-week drug-free observation period, with final assessment at week 64.

Extension Period (up to week 156): Participants who have not developed diabetes and provide consent may continue follow-up for long-term cardiovascular outcomes assessment at weeks 104 and 156.

The primary endpoint is the proportion of participants achieving reversion to normal glucose metabolism at week 64. Secondary endpoints include progression to type 2 diabetes, changes in fasting plasma glucose, OGTT (1h/2h PPG), HbA1c, lipid profile (TG, TC, LDL-C, HDL-C), blood pressure, UACR, HOMA-IR, HOMA-β, body weight, BMI, and waist-to-height ratio. Exploratory endpoints include changes in inflammatory markers (hsCRP, IL-6, TNF-α) and incidence of heart failure, non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, or all-cause death through week 156. Safety will be monitored throughout.

研究の種類

介入

入学 (推定)

472

段階

  • 適用できない

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

研究連絡先のバックアップ

研究場所

  • 中国
      • Beijing、中国
        • Xuanwu Hospital Capital Medical University
        • コンタクト：
        • 主任研究者：
          • YU Sun, MD, PhD
      • Beijing、中国
        • Beijing Tsinghua Changgung Hospital
        • コンタクト：
      • Beijing、中国
        • Emergency General Hospital
        • コンタクト：
          • Kailiang Wang, MD, M.M.
          • 電話番号：+861087935595
          • メール：ht15s@163.com
      • Chongqing、中国、400038
        • The Southwest Hospital of the Army Medical University
        • コンタクト：
        • 主任研究者：
          • Min Long, MD, PhD
      • Shanghai、中国
        • Shanghai Ninth People's Hospital
        • コンタクト：
      • Shanghai、中国
        • Tongji Hospital of Tongji University
      • Shenzhen、中国
        • Shenzhen Bao'an People's Hospital
        • コンタクト：
          • Jisu Xue, MD, PhD
          • 電話番号：+8675527783061
          • メール：baxjs@126.com
      • Shenzhen、中国
        • Shenzhen Bao'an Traditional Chinese Medicine Hospital
        • コンタクト：
          • Yanping Zheng, MD, M.M.
          • 電話番号：+8675527831439
          • メール：panyanyes@163.com
    • Fujian
      • Quanzhou、Fujian、中国
        • Quanzhou First Hospital, Fujian
        • コンタクト：
          • Yi Zhang, MD, PhD
          • 電話番号：+8659522277157
          • メール：2005064@163.com
    • Guangdong
      • Guangzhou、Guangdong、中国
        • The First Affiliated Hospital of Guangzhou Medical University
        • コンタクト：
          • Xiaoyan Chen, MD, PhD
          • 電話番号：+862083062114
          • メール：gzscxy@126.com
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150086
        • The Second Affiliated Hospital of Harbin Medical University
        • コンタクト：
        • 主任研究者：
          • Hong Qiao, MD, PhD
      • Harbin、Heilongjiang、中国、150010
        • The First Hospital of Harbin
        • コンタクト：
        • 主任研究者：
          • Binhua Xu, MD, M.M.
    • Henan
      • Luoyang、Henan、中国
        • The First Affiliated Hospital of Henan University of Science & Technology
        • コンタクト：
    • Hubei
      • Wuhan、Hubei、中国、430071
        • Zhongnan Hospital of Wuhan University
        • コンタクト：
          • Zhe Dai, MD, PhD
          • 電話番号：+862767812787
          • メール：betamm@163.com
        • 主任研究者：
          • Zhe Dai, MD, PhD
    • Hunan
      • Changde、Hunan、中国
        • The First People's Hospital of Changde City
        • コンタクト：
      • Changsha、Hunan、中国
        • The Third XIANGYA Hospital of Central South University
        • コンタクト：
      • Changsha、Hunan、中国
        • People's Hospital of Hunan Province
        • コンタクト：
      • Changsha、Hunan、中国、410011
        • The Second Xiangya Hospital, Central South University
        • 主任研究者：
          • Zhiguang Zhou, MD, PhD
        • コンタクト：
        • 副調査官：
          • Chuqing Cao, MD, PhD
      • Changsha、Hunan、中国
        • Changsha Eighth Hospital
        • コンタクト：
      • Loudi、Hunan、中国
        • Loudi Central Hospital
        • コンタクト：
          • Weiping Sun, MD, PhD
          • 電話番号：+867388527739
          • メール：sunwp07@163.com
      • Xiangtan、Hunan、中国
        • The Central Hospital of Xiangtan
        • コンタクト：
      • Yongzhou、Hunan、中国
        • The Central Hospital of Yongzhou
        • コンタクト：
      • Yueyang、Hunan、中国
        • Yueyang People's Hospital
        • コンタクト：
          • Dijun Zhou, MD, PhD
          • 電話番号：+867308725393
          • メール：Z121300@126.com
    • Jiangsu
      • Nanjing、Jiangsu、中国
        • Sir Run Run Hospital, Nanjing Medical University
        • コンタクト：
    • Shanxi
      • Changzhi、Shanxi、中国
        • Heji Hospital Affiliated to Changzhi Medical College
        • コンタクト：
          • Xiaohong Niu, MD, PhD
          • 電話番号：+863553552855
          • メール：610115220@qq.com
    • Sichuan
      • Chengdu、Sichuan、中国、610072
        • Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
        • コンタクト：
        • 主任研究者：
          • Limin Tian, MD,PhD
      • Chengdu、Sichuan、中国、610036
        • The Third People's Hospital of Chengdu
        • コンタクト：
        • 主任研究者：
          • Xiaowei Zhong, MD,PhD
      • Chengdu、Sichuan、中国、610499
        • Chengdu First People's Hospital
        • コンタクト：
        • 主任研究者：
          • Lin Pu, MD,M.M.
    • Yunnan
      • Kunming、Yunnan、中国
        • The First Affiliated Hospital of Kunming Medical University
        • コンタクト：
    • Zhejiang
      • Hangzhou、Zhejiang、中国
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • コンタクト：

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:

1.Voluntarily signed informed consent. 2. Age 18 to 70 years, inclusive. 3. Diagnosed with prediabetes according to the Chinese expert consensus on intervention for adults with pre-diabetes (2023 edition), meeting any of the following criteria:

  1. Impaired fasting glucose (IFG): fasting plasma glucose (FPG) ≥ 6.1 mmol/L and < 7.0 mmol/L, with 2-hour postprandial glucose (2hPG) < 7.8 mmol/L and HbA1c < 6.5%
  2. Impaired glucose tolerance (IGT): FPG < 6.1 mmol/L, with 2hPG ≥ 7.8 mmol/L and < 11.1 mmol/L, and HbA1c < 6.5%
  3. IFG + IGT, with HbA1c < 6.5%
  4. HbA1c 5.7% to 6.4% (inclusive), with FPG and OGTT 2hPG not meeting diabetes diagnostic criteria 4. Body Mass Index (BMI) 20-32 kg/m². 5. For women of childbearing potential, must agree to use a highly effective method of contraception throughout the study.

Exclusion Criteria:

  1. Use of glucose-lowering medications within 3 months prior to screening.
  2. Major cardiovascular or cerebrovascular events within 6 months prior to screening, defined as:

1)Acute myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, severe arrhythmias (e.g., ventricular fibrillation, atrial flutter, atrial fibrillation, etc.), unstable angina, transient ischemic attack, ischemic stroke, or hemorrhagic stroke 2)New York Heart Association (NYHA) class III or IV congestive heart failure 3)Current use of loop diuretics or digitalis 3.Uncontrolled hypertension: systolic blood pressure (SBP) ≥ 160 mmHg and/or diastolic blood pressure (DBP) ≥ 100 mmHg despite treatment, or use of three or more antihypertensive agents with inadequate control (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg).

4.eGFR ≤ 15 mL/min/1.73 m² (CKD-EPI Creatinine Equation 2021). 5.Urinary albumin-to-creatinine ratio (UACR) > 300 mg/g. 6.Hemoglobin < 110 g/L. 7.Fasting triglycerides > 5.6 mmol/L (500 mg/dL). 8.Active liver disease or significant hepatic dysfunction, defined as AST > 2.5×ULN and/or ALT > 2.5×ULN and/or total bilirubin > 1.5×ULN.

9.Severe pulmonary disease with treatments that may potentially affect glucose metabolism (e.g., inhaled corticosteroids, beta-agonists).

10.History of acute or chronic pancreatitis, or history of gallbladder or bile duct disease (except post-cholecystectomy for gallstones or cholecystitis).

11.Gastrointestinal disorders affecting gastric emptying, such as gastroparesis, postoperative gastric stasis, idiopathic gastroparesis, gastroesophageal reflux disease, pyloric stenosis or obstruction, intestinal obstruction; severe chronic gastrointestinal disease (e.g., active ulcer, intestinal tuberculosis within 6 months prior to screening); history of frequent nausea, vomiting, or irregular gastrointestinal motility from any cause (e.g., habitual diarrhea, habitual constipation, inflammatory bowel disease, irritable bowel syndrome); or long-term use of medications directly affecting gastrointestinal motility.

12.Recent abdominal surgery or history of major abdominal surgery. 13.Thyroid dysfunction or other endocrine diseases affecting glucose metabolism (Cushing's syndrome, acromegaly, pheochromocytoma, prolactinoma, etc.), except stable treated hypothyroidism (for 3 months) or subclinical hypothyroidism not requiring treatment.

14.History of malignancy within 5 years prior to screening, or current malignancy.

15.History of tuberculosis or current use of anti-tuberculosis medications. 16.Current use of antipsychotic agents, alcohol abuse, or drug dependence. 17.Current use of thiazide diuretics, beta-blockers, nicotinic acid for lipid-lowering, systemic glucocorticoids, or weight-loss medications.

18.Known hypersensitivity to Chiglitazar Sodium or its components. 19.Pregnancy or breastfeeding. 20.Unexplained weight loss > 10% of baseline body weight within 6 months prior to screening.

21.Participation in another clinical trial within 3 months prior to screening. 22.Any other condition that, in the investigator's judgment, would preclude the participant from completing the study or pose significant risk to the participant.

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：Chiglitazar Sodium + Lifestyle Intervention
Participants will receive Chiglitazar Sodium 48 mg orally once daily, combined with standardized lifestyle intervention (diet and exercise counseling), for 52 weeks.
薬：Chiglitazar sodium
Chiglitazar Sodium tablet, 48 mg, oral, once daily, administered from randomization through week 52. Combined with standardized lifestyle intervention provided throughout the study period.
プラセボコンパレーター：Placebo + Lifestyle Intervention
Participants will receive matching placebo (Chiglitazar Sodium simulation tablet) 48 mg orally once daily, combined with standardized lifestyle intervention (diet and exercise counseling), for 52 weeks.
薬：Placebo
Matching placebo (Chiglitazar Sodium simulation tablet), 48 mg, oral, once daily, administered from randomization through week 52. Combined with standardized lifestyle intervention provided throughout the study period.

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
Reversion Rate to Normal Glucose Metabolism
時間枠：Week 64
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Week 64

二次結果の測定

結果測定
メジャーの説明
時間枠
Reversion Rate to Normal Glucose Metabolism
時間枠：Week 24, Week 52
Proportion of participants achieving reversion to normal glucose metabolism at week 24 and week 52.
Week 24, Week 52
Progression Rate to Type 2 Diabetes
時間枠：Week 24, Week 52, Week 64
Proportion of participants progressing to type 2 diabetes at week 24, week 52, and week 64.
Week 24, Week 52, Week 64
Change From Baseline in Fasting Plasma Glucose (FPG)
時間枠：Week 24, Week 52, Week 64
Change from baseline in fasting plasma glucose level.
Week 24, Week 52, Week 64
Change From Baseline in OGTT 1-hour and 2-hour Postprandial Glucose (PPG)
時間枠：Week 24, Week 52, Week 64
Change from baseline in plasma glucose at 1 hour and 2 hours during oral glucose tolerance test.
Week 24, Week 52, Week 64
Change From Baseline in HbA1c
時間枠：Week 24, Week 52, Week 64
Change from baseline in glycated hemoglobin level
Week 24, Week 52, Week 64
Change From Baseline in Lipid Profile
時間枠：Week 24, Week 52, Week 64
Change from baseline in triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).
Week 24, Week 52, Week 64
Change From Baseline in Blood Pressure
時間枠：Week 24, Week 52, Week 64
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Week 24, Week 52, Week 64
Change From Baseline in UACR
時間枠：Week 24, Week 52, Week 64
Change from baseline in urinary albumin-to-creatinine ratio
Week 24, Week 52, Week 64
Change From Baseline in HOMA-IR
時間枠：Week 24, Week 52, Week 64
Change from baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Week 24, Week 52, Week 64
Change From Baseline in HOMA-β
時間枠：Week 24, Week 52, Week 64
Change from baseline in Homeostatic Model Assessment of β-cell function (HOMA-β).
Week 24, Week 52, Week 64
Change From Baseline in Body Weight
時間枠：Week 24, Week 52, Week 64
Change from baseline in body weight
Week 24, Week 52, Week 64
Change From Baseline in BMI
時間枠：Week 24, Week 52, Week 64
Change from baseline in body mass index (BMI).
Week 24, Week 52, Week 64
Change From Baseline in Waist-to-Height Ratio
時間枠：Week 24, Week 52, Week 64
Change from baseline in waist-to-height ratio.
Week 24, Week 52, Week 64

その他の成果指標

結果測定
メジャーの説明
時間枠
Change From Baseline in Inflammatory Markers
時間枠：Week 24, Week 52, Week 64
Change from baseline in high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α).
Week 24, Week 52, Week 64
Incidence of Composite Cardiovascular Event
時間枠：Week 104, Week 156
Incidence of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, or heart failure throughout.
Week 104, Week 156
Incidence of All-Cause Death
時間枠：Week 104, Week 156
Incidence of all-cause death throughout.
Week 104, Week 156
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
時間枠：Throughout the study (up to week 156)
Overall incidence of treatment-emergent adverse events and serious adverse events throughout the study.
Throughout the study (up to week 156)

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

Second Xiangya Hospital of Central South University

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4月18日

一次修了 (推定)

2028年12月31日

研究の完了 (推定)

2029年12月31日

試験登録日

最初に提出

2026年4月22日

QC基準を満たした最初の提出物

2026年4月22日

最初の投稿 (実際)

2026年4月30日

学習記録の更新

投稿された最後の更新 (実際)

2026年4月30日

QC基準を満たした最後の更新が送信されました

2026年4月22日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PRECISE trial

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

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