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Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

2026년 4월 22일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

472

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

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  • 고령자

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아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
의약품: 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.
위약 비교기: 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.
의약품: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Reversion Rate to Normal Glucose Metabolism
기간: Week 64
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Week 64

2차 결과 측정

결과 측정
측정값 설명
기간
Reversion Rate to Normal Glucose Metabolism
기간: 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
기간: 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)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: Week 24, Week 52, Week 64
Change from baseline in body weight
Week 24, Week 52, Week 64
Change From Baseline in BMI
기간: 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
기간: Week 24, Week 52, Week 64
Change from baseline in waist-to-height ratio.
Week 24, Week 52, Week 64

기타 결과 측정

결과 측정
측정값 설명
기간
Change From Baseline in Inflammatory Markers
기간: 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
기간: 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
기간: Week 104, Week 156
Incidence of all-cause death throughout.
Week 104, Week 156
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
기간: 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)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Second Xiangya Hospital of Central South University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 4월 18일

기본 완료 (추정된)

2028년 12월 31일

연구 완료 (추정된)

2029년 12월 31일

연구 등록 날짜

최초 제출

2026년 4월 22일

QC 기준을 충족하는 최초 제출

2026년 4월 22일

처음 게시됨 (실제)

2026년 4월 30일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 4월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 4월 22일

마지막으로 확인됨

2026년 4월 1일

추가 정보

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추가 관련 MeSH 약관

기타 연구 ID 번호

  • PRECISE trial

개별 참가자 데이터(IPD) 계획

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이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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