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Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

22 de abril de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

472

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

  • Nombre: Chuqing Cao, MD, PhD
  • Número de teléfono: +8673185292154
  • Correo electrónico: caochuqing@csu.edu.cn

Ubicaciones de estudio

  • Porcelana
      • Beijing, Porcelana
        • Xuanwu Hospital Capital Medical University
        • Contacto:
        • Investigador principal:
          • YU Sun, MD, PhD
      • Beijing, Porcelana
        • Beijing Tsinghua Changgung Hospital
        • Contacto:
      • Beijing, Porcelana
        • Emergency General Hospital
        • Contacto:
          • Kailiang Wang, MD, M.M.
          • Número de teléfono: +861087935595
          • Correo electrónico: ht15s@163.com
      • Chongqing, Porcelana, 400038
        • The Southwest Hospital of the Army Medical University
        • Contacto:
          • Min Long, MD, PhD
          • Número de teléfono: +862365318301
          • Correo electrónico: chzijing@126.com
        • Investigador principal:
          • Min Long, MD, PhD
      • Shanghai, Porcelana
        • Shanghai Ninth People's Hospital
        • Contacto:
          • Jie Qiao, MD, PhD
          • Número de teléfono: +862123271699
          • Correo electrónico: qiaoj2001@126.com
      • Shanghai, Porcelana
        • Tongji Hospital of Tongji University
      • Shenzhen, Porcelana
        • Shenzhen Bao'an People's Hospital
        • Contacto:
          • Jisu Xue, MD, PhD
          • Número de teléfono: +8675527783061
          • Correo electrónico: baxjs@126.com
      • Shenzhen, Porcelana
        • Shenzhen Bao'an Traditional Chinese Medicine Hospital
        • Contacto:
          • Yanping Zheng, MD, M.M.
          • Número de teléfono: +8675527831439
          • Correo electrónico: panyanyes@163.com
    • Fujian
      • Quanzhou, Fujian, Porcelana
        • Quanzhou First Hospital, Fujian
        • Contacto:
          • Yi Zhang, MD, PhD
          • Número de teléfono: +8659522277157
          • Correo electrónico: 2005064@163.com
    • Guangdong
      • Guangzhou, Guangdong, Porcelana
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contacto:
          • Xiaoyan Chen, MD, PhD
          • Número de teléfono: +862083062114
          • Correo electrónico: gzscxy@126.com
    • Heilongjiang
      • Harbin, Heilongjiang, Porcelana, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Contacto:
          • Hong Qiao, MD, PhD
          • Número de teléfono: +8645186605084
          • Correo electrónico: 13359864888@163.com
        • Investigador principal:
          • Hong Qiao, MD, PhD
      • Harbin, Heilongjiang, Porcelana, 150010
        • The First Hospital of Harbin
        • Contacto:
          • Binhua Xu, MD, M.M.
          • Número de teléfono: +8645184883051
          • Correo electrónico: binhuaxu@sina.com
        • Investigador principal:
          • Binhua Xu, MD, M.M.
    • Henan
      • Luoyang, Henan, Porcelana
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contacto:
          • Hongwei Jiang, MD, PhD
          • Número de teléfono: +8637964922216
          • Correo electrónico: jianghw@haust.edu.cn
    • Hubei
      • Wuhan, Hubei, Porcelana, 430071
        • Zhongnan Hospital of Wuhan University
        • Contacto:
          • Zhe Dai, MD, PhD
          • Número de teléfono: +862767812787
          • Correo electrónico: betamm@163.com
        • Investigador principal:
          • Zhe Dai, MD, PhD
    • Hunan
      • Changde, Hunan, Porcelana
        • The First People's Hospital of Changde City
        • Contacto:
          • Shenglian Gan, MD, M.M.
          • Número de teléfono: +867367788890
          • Correo electrónico: Gslghy03@sina.com
      • Changsha, Hunan, Porcelana
        • The Third XIANGYA Hospital of Central South University
        • Contacto:
      • Changsha, Hunan, Porcelana
        • People's Hospital of Hunan Province
        • Contacto:
          • Xinlan Zhao, MD, M.M.
          • Número de teléfono: +8673183929085
          • Correo electrónico: qiqihaohao@163.com
      • Changsha, Hunan, Porcelana, 410011
        • The Second Xiangya Hospital, Central South University
        • Investigador principal:
          • Zhiguang Zhou, MD, PhD
        • Contacto:
        • Sub-Investigador:
          • Chuqing Cao, MD, PhD
      • Changsha, Hunan, Porcelana
        • Changsha Eighth Hospital
        • Contacto:
          • Weidong Zhou, MD, PhD
          • Número de teléfono: +8673185259000
          • Correo electrónico: zhousufe@outlook.com
      • Loudi, Hunan, Porcelana
        • Loudi Central Hospital
        • Contacto:
          • Weiping Sun, MD, PhD
          • Número de teléfono: +867388527739
          • Correo electrónico: sunwp07@163.com
      • Xiangtan, Hunan, Porcelana
        • The Central Hospital of Xiangtan
        • Contacto:
      • Yongzhou, Hunan, Porcelana
        • The Central Hospital of Yongzhou
        • Contacto:
      • Yueyang, Hunan, Porcelana
        • Yueyang People's Hospital
        • Contacto:
          • Dijun Zhou, MD, PhD
          • Número de teléfono: +867308725393
          • Correo electrónico: Z121300@126.com
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana
        • Sir Run Run Hospital, Nanjing Medical University
        • Contacto:
          • Yu Liu
          • Número de teléfono: +862587115593
          • Correo electrónico: hhm0403@163.com
    • Shanxi
      • Changzhi, Shanxi, Porcelana
        • Heji Hospital Affiliated to Changzhi Medical College
        • Contacto:
          • Xiaohong Niu, MD, PhD
          • Número de teléfono: +863553552855
          • Correo electrónico: 610115220@qq.com
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610072
        • Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
        • Contacto:
          • Limin Tian, MD,PhD
          • Número de teléfono: +862887393449
          • Correo electrónico: 1072027801@qq.com
        • Investigador principal:
          • Limin Tian, MD,PhD
      • Chengdu, Sichuan, Porcelana, 610036
        • The Third People's Hospital of Chengdu
        • Contacto:
          • Xiaowei Zhong, MD,PhD
          • Número de teléfono: +862861318530
          • Correo electrónico: 13541044788@126.com
        • Investigador principal:
          • Xiaowei Zhong, MD,PhD
      • Chengdu, Sichuan, Porcelana, 610499
        • Chengdu First People's Hospital
        • Contacto:
          • Lin Pu, MD,M.M.
          • Número de teléfono: +862885313280
          • Correo electrónico: 541371995@qq.com
        • Investigador principal:
          • Lin Pu, MD,M.M.
    • Yunnan
      • Kunming, Yunnan, Porcelana
        • The First Affiliated Hospital of Kunming Medical University
        • Contacto:
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Droga: 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.
Comparador de placebos: 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.
Droga: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Reversion Rate to Normal Glucose Metabolism
Periodo de tiempo: Week 64
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Week 64

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Reversion Rate to Normal Glucose Metabolism
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 24, Week 52, Week 64
Change from baseline in body weight
Week 24, Week 52, Week 64
Change From Baseline in BMI
Periodo de tiempo: 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
Periodo de tiempo: Week 24, Week 52, Week 64
Change from baseline in waist-to-height ratio.
Week 24, Week 52, Week 64

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Change From Baseline in Inflammatory Markers
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Week 104, Week 156
Incidence of all-cause death throughout.
Week 104, Week 156
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Second Xiangya Hospital of Central South University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

18 de abril de 2026

Finalización primaria (Estimado)

31 de diciembre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2029

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

22 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de abril de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

22 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PRECISE trial

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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