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Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

22 de abril de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

472

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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.
Medicamento: 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 Placebo: 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.
Medicamento: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Reversion Rate to Normal Glucose Metabolism
Prazo: Week 64
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Week 64

Medidas de resultados secundários

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

Outras medidas de resultado

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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Second Xiangya Hospital of Central South University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

18 de abril de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2028

Conclusão do estudo (Estimado)

31 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

22 de abril de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de abril de 2026

Primeira postagem (Real)

30 de abril de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

30 de abril de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de abril de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PRECISE trial

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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