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Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

22 avril 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

472

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

  • Chine
      • Beijing, Chine
        • Xuanwu Hospital Capital Medical University
        • Contact:
        • Chercheur principal:
          • YU Sun, MD, PhD
      • Beijing, Chine
        • Beijing Tsinghua Changgung Hospital
        • Contact:
      • Beijing, Chine
        • Emergency General Hospital
        • Contact:
          • Kailiang Wang, MD, M.M.
          • Numéro de téléphone: +861087935595
          • E-mail: ht15s@163.com
      • Chongqing, Chine, 400038
        • The Southwest Hospital of the Army Medical University
        • Contact:
          • Min Long, MD, PhD
          • Numéro de téléphone: +862365318301
          • E-mail: chzijing@126.com
        • Chercheur principal:
          • Min Long, MD, PhD
      • Shanghai, Chine
        • Shanghai Ninth People's Hospital
        • Contact:
      • Shanghai, Chine
        • Tongji Hospital of Tongji University
      • Shenzhen, Chine
        • Shenzhen Bao'an People's Hospital
        • Contact:
          • Jisu Xue, MD, PhD
          • Numéro de téléphone: +8675527783061
          • E-mail: baxjs@126.com
      • Shenzhen, Chine
        • Shenzhen Bao'an Traditional Chinese Medicine Hospital
        • Contact:
          • Yanping Zheng, MD, M.M.
          • Numéro de téléphone: +8675527831439
          • E-mail: panyanyes@163.com
    • Fujian
      • Quanzhou, Fujian, Chine
        • Quanzhou First Hospital, Fujian
        • Contact:
          • Yi Zhang, MD, PhD
          • Numéro de téléphone: +8659522277157
          • E-mail: 2005064@163.com
    • Guangdong
      • Guangzhou, Guangdong, Chine
        • The First Affiliated Hospital of Guangzhou Medical University
        • Contact:
          • Xiaoyan Chen, MD, PhD
          • Numéro de téléphone: +862083062114
          • E-mail: gzscxy@126.com
    • Heilongjiang
      • Harbin, Heilongjiang, Chine, 150086
        • The Second Affiliated Hospital of Harbin Medical University
        • Contact:
        • Chercheur principal:
          • Hong Qiao, MD, PhD
      • Harbin, Heilongjiang, Chine, 150010
        • The First Hospital of Harbin
        • Contact:
          • Binhua Xu, MD, M.M.
          • Numéro de téléphone: +8645184883051
          • E-mail: binhuaxu@sina.com
        • Chercheur principal:
          • Binhua Xu, MD, M.M.
    • Henan
      • Luoyang, Henan, Chine
        • The First Affiliated Hospital of Henan University of Science & Technology
        • Contact:
    • Hubei
      • Wuhan, Hubei, Chine, 430071
        • Zhongnan Hospital of Wuhan University
        • Contact:
          • Zhe Dai, MD, PhD
          • Numéro de téléphone: +862767812787
          • E-mail: betamm@163.com
        • Chercheur principal:
          • Zhe Dai, MD, PhD
    • Hunan
      • Changde, Hunan, Chine
        • The First People's Hospital of Changde City
        • Contact:
          • Shenglian Gan, MD, M.M.
          • Numéro de téléphone: +867367788890
          • E-mail: Gslghy03@sina.com
      • Changsha, Hunan, Chine
        • The Third XIANGYA Hospital of Central South University
        • Contact:
      • Changsha, Hunan, Chine
        • People's Hospital of Hunan Province
        • Contact:
      • Changsha, Hunan, Chine, 410011
        • The Second Xiangya Hospital, Central South University
        • Chercheur principal:
          • Zhiguang Zhou, MD, PhD
        • Contact:
        • Sous-enquêteur:
          • Chuqing Cao, MD, PhD
      • Changsha, Hunan, Chine
        • Changsha Eighth Hospital
        • Contact:
      • Loudi, Hunan, Chine
        • Loudi Central Hospital
        • Contact:
          • Weiping Sun, MD, PhD
          • Numéro de téléphone: +867388527739
          • E-mail: sunwp07@163.com
      • Xiangtan, Hunan, Chine
        • The Central Hospital of Xiangtan
        • Contact:
      • Yongzhou, Hunan, Chine
        • The Central Hospital of Yongzhou
        • Contact:
      • Yueyang, Hunan, Chine
        • Yueyang People's Hospital
        • Contact:
          • Dijun Zhou, MD, PhD
          • Numéro de téléphone: +867308725393
          • E-mail: Z121300@126.com
    • Jiangsu
      • Nanjing, Jiangsu, Chine
        • Sir Run Run Hospital, Nanjing Medical University
        • Contact:
    • Shanxi
      • Changzhi, Shanxi, Chine
        • Heji Hospital Affiliated to Changzhi Medical College
        • Contact:
          • Xiaohong Niu, MD, PhD
          • Numéro de téléphone: +863553552855
          • E-mail: 610115220@qq.com
    • Sichuan
      • Chengdu, Sichuan, Chine, 610072
        • Sichuan Academy of Medical Sciences ＆ Sichuan Provincial People's Hospital
        • Contact:
        • Chercheur principal:
          • Limin Tian, MD,PhD
      • Chengdu, Sichuan, Chine, 610036
        • The Third People's Hospital of Chengdu
        • Contact:
        • Chercheur principal:
          • Xiaowei Zhong, MD,PhD
      • Chengdu, Sichuan, Chine, 610499
        • Chengdu First People's Hospital
        • Contact:
          • Lin Pu, MD,M.M.
          • Numéro de téléphone: +862885313280
          • E-mail: 541371995@qq.com
        • Chercheur principal:
          • Lin Pu, MD,M.M.
    • Yunnan
      • Kunming, Yunnan, Chine
        • The First Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, Chine
        • The Second Affiliated Hospital Zhejiang University School of Medicine
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Quadruple

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Médicament: 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.
Comparateur 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.
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Reversion Rate to Normal Glucose Metabolism
Délai: Week 64
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Week 64

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Reversion Rate to Normal Glucose Metabolism
Délai: 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
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: Week 24, Week 52, Week 64
Change from baseline in body weight
Week 24, Week 52, Week 64
Change From Baseline in BMI
Délai: 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
Délai: Week 24, Week 52, Week 64
Change from baseline in waist-to-height ratio.
Week 24, Week 52, Week 64

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Change From Baseline in Inflammatory Markers
Délai: 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
Délai: 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
Délai: Week 104, Week 156
Incidence of all-cause death throughout.
Week 104, Week 156
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Délai: 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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Second Xiangya Hospital of Central South University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

18 avril 2026

Achèvement primaire (Estimé)

31 décembre 2028

Achèvement de l'étude (Estimé)

31 décembre 2029

Dates d'inscription aux études

Première soumission

22 avril 2026

Première soumission répondant aux critères de contrôle qualité

22 avril 2026

Première publication (Réel)

30 avril 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

30 avril 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 avril 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • PRECISE trial

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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