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Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

22. dubna 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

472

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

Studijní místa

  • Čína
      • Beijing, Čína
        • Xuanwu Hospital Capital Medical University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • YU Sun, MD, PhD
      • Beijing, Čína
        • Beijing Tsinghua Changgung Hospital
        • Kontakt:
      • Beijing, Čína
        • Emergency General Hospital
        • Kontakt:
          • Kailiang Wang, MD, M.M.
          • Telefonní číslo: +861087935595
          • E-mail: ht15s@163.com
      • Chongqing, Čína, 400038
        • The Southwest Hospital of the Army Medical University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Min Long, MD, PhD
      • Shanghai, Čína
        • Shanghai Ninth People's Hospital
        • Kontakt:
      • Shanghai, Čína
        • Tongji Hospital of Tongji University
      • Shenzhen, Čína
        • Shenzhen Bao'an People's Hospital
        • Kontakt:
          • Jisu Xue, MD, PhD
          • Telefonní číslo: +8675527783061
          • E-mail: baxjs@126.com
      • Shenzhen, Čína
        • Shenzhen Bao'an Traditional Chinese Medicine Hospital
        • Kontakt:
          • Yanping Zheng, MD, M.M.
          • Telefonní číslo: +8675527831439
          • E-mail: panyanyes@163.com
    • Fujian
      • Quanzhou, Fujian, Čína
        • Quanzhou First Hospital, Fujian
        • Kontakt:
          • Yi Zhang, MD, PhD
          • Telefonní číslo: +8659522277157
          • E-mail: 2005064@163.com
    • Guangdong
      • Guangzhou, Guangdong, Čína
        • The First Affiliated Hospital of Guangzhou Medical University
        • Kontakt:
          • Xiaoyan Chen, MD, PhD
          • Telefonní číslo: +862083062114
          • E-mail: gzscxy@126.com
    • Heilongjiang
      • Harbin, Heilongjiang, Čína, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Hong Qiao, MD, PhD
      • Harbin, Heilongjiang, Čína, 150010
        • The First Hospital of Harbin
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Binhua Xu, MD, M.M.
    • Henan
      • Luoyang, Henan, Čína
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Kontakt:
    • Hubei
      • Wuhan, Hubei, Čína, 430071
        • Zhongnan Hospital of Wuhan University
        • Kontakt:
          • Zhe Dai, MD, PhD
          • Telefonní číslo: +862767812787
          • E-mail: betamm@163.com
        • Vrchní vyšetřovatel:
          • Zhe Dai, MD, PhD
    • Hunan
      • Changde, Hunan, Čína
        • The First People's Hospital of Changde City
        • Kontakt:
          • Shenglian Gan, MD, M.M.
          • Telefonní číslo: +867367788890
          • E-mail: Gslghy03@sina.com
      • Changsha, Hunan, Čína
        • The Third Xiangya Hospital of Central South University
        • Kontakt:
      • Changsha, Hunan, Čína
        • People's Hospital of Hunan Province
        • Kontakt:
      • Changsha, Hunan, Čína, 410011
        • The Second Xiangya Hospital, Central South University
        • Vrchní vyšetřovatel:
          • Zhiguang Zhou, MD, PhD
        • Kontakt:
        • Dílčí vyšetřovatel:
          • Chuqing Cao, MD, PhD
      • Changsha, Hunan, Čína
        • Changsha Eighth Hospital
        • Kontakt:
      • Loudi, Hunan, Čína
        • Loudi Central Hospital
        • Kontakt:
          • Weiping Sun, MD, PhD
          • Telefonní číslo: +867388527739
          • E-mail: sunwp07@163.com
      • Xiangtan, Hunan, Čína
        • The Central Hospital of Xiangtan
        • Kontakt:
      • Yongzhou, Hunan, Čína
        • The Central Hospital of Yongzhou
        • Kontakt:
      • Yueyang, Hunan, Čína
        • YueYang People's Hospital
        • Kontakt:
          • Dijun Zhou, MD, PhD
          • Telefonní číslo: +867308725393
          • E-mail: Z121300@126.com
    • Jiangsu
      • Nanjing, Jiangsu, Čína
        • Sir Run Run Hospital, Nanjing Medical University
        • Kontakt:
    • Shanxi
      • Changzhi, Shanxi, Čína
        • Heji Hospital Affiliated to Changzhi Medical College
        • Kontakt:
          • Xiaohong Niu, MD, PhD
          • Telefonní číslo: +863553552855
          • E-mail: 610115220@qq.com
    • Sichuan
      • Chengdu, Sichuan, Čína, 610072
        • Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Limin Tian, MD,PhD
      • Chengdu, Sichuan, Čína, 610036
        • The Third People's Hospital of Chengdu
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Xiaowei Zhong, MD,PhD
      • Chengdu, Sichuan, Čína, 610499
        • Chengdu First People's Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Lin Pu, MD,M.M.
    • Yunnan
      • Kunming, Yunnan, Čína
        • The First Affiliated Hospital of Kunming Medical University
        • Kontakt:
    • Zhejiang
      • Hangzhou, Zhejiang, Čína
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Kontakt:

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Lék: 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.
Komparátor placeba: 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.
Lék: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reversion Rate to Normal Glucose Metabolism
Časové okno: Week 64
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Week 64

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reversion Rate to Normal Glucose Metabolism
Časové okno: 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
Časové okno: 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)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: Week 24, Week 52, Week 64
Change from baseline in body weight
Week 24, Week 52, Week 64
Change From Baseline in BMI
Časové okno: 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
Časové okno: Week 24, Week 52, Week 64
Change from baseline in waist-to-height ratio.
Week 24, Week 52, Week 64

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change From Baseline in Inflammatory Markers
Časové okno: 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
Časové okno: 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
Časové okno: Week 104, Week 156
Incidence of all-cause death throughout.
Week 104, Week 156
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Second Xiangya Hospital of Central South University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

18. dubna 2026

Primární dokončení (Odhadovaný)

31. prosince 2028

Dokončení studie (Odhadovaný)

31. prosince 2029

Termíny zápisu do studia

První předloženo

22. dubna 2026

První předloženo, které splnilo kritéria kontroly kvality

22. dubna 2026

První zveřejněno (Aktuální)

30. dubna 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

30. dubna 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. dubna 2026

Naposledy ověřeno

1. dubna 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • PRECISE trial

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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