PrediabetesNCT07558525
Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes
A study testing Chiglitazar sodium in people with Prediabetes, run by Second Xiangya Hospital of Central South University at 30 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prediabetes
- What is being tested?
- Chiglitazar sodium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 472 participants
- Where
- 30 sitesChina
- Study dates
- 18 Apr 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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%
- Impaired glucose tolerance (IGT): FPG < 6.1 mmol/L, with 2hPG ≥ 7.8 mmol/L and < 11.1 mmol/L, and HbA1c < 6.5%
- IFG + IGT, with HbA1c < 6.5%
- 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.
Who cannot join
- Use of glucose-lowering medications within 3 months prior to screening.
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
30 sites in 1 country
China30 sites
Beijing Tsinghua Changgung Hospital
Beijing
Jianzhong Xiao, +861056118567, xjza01150@btch.edu.cn
Emergency General Hospital
Beijing
Kailiang Wang, MD, M.M., +861087935595, ht15s@163.com
Xuanwu Hospital Capital Medical University
Beijing
Yu Sun, MD, PhD, +861083198384, 18560083995@163.com
YU Sun, MD, PhD
The First People's Hospital of Changde City
Changde, Hunan
Shenglian Gan, MD, M.M., +867367788890, Gslghy03@sina.com
The Second Xiangya Hospital, Central South University
Changsha, Hunan, 410011
Chuqing Cao, MD, PhD, +8673185292154, caochuqing@csu.edu.cn
Zhiguang Zhou, MD, PhD
Changsha Eighth Hospital
Changsha, Hunan
Weidong Zhou, MD, PhD, +8673185259000, zhousufe@outlook.com
People's Hospital of Hunan Province
Changsha, Hunan
Xinlan Zhao, MD, M.M., +8673183929085, qiqihaohao@163.com
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Ping Jin, MD, M.M., +8673188618938, ping.jin06@csu.edu.cn
Heji Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi
Xiaohong Niu, MD, PhD, +863553552855, 610115220@qq.com
The Third People's Hospital of Chengdu
Chengdu, Sichuan, 610036
Xiaowei Zhong, MD,PhD, +862861318530, 13541044788@126.com
Xiaowei Zhong, MD,PhD
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Limin Tian, MD,PhD, +862887393449, 1072027801@qq.com
Limin Tian, MD,PhD
Chengdu First People's Hospital
Chengdu, Sichuan, 610499
Lin Pu, MD,M.M., +862885313280, 541371995@qq.com
Lin Pu, MD,M.M.
The Southwest Hospital of the Army Medical University
Chongqing, 400038
Min Long, MD, PhD, +862365318301, chzijing@126.com
Min Long, MD, PhD
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong
Xiaoyan Chen, MD, PhD, +862083062114, gzscxy@126.com
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
Chao Zheng, MD, PhD, +8657187783759, chao_zheng@zju.edu.cn
The First Hospital of Harbin
Harbin, Heilongjiang, 150010
Binhua Xu, MD, M.M., +8645184883051, binhuaxu@sina.com
Binhua Xu, MD, M.M.
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150086
Hong Qiao, MD, PhD, +8645186605084, 13359864888@163.com
Hong Qiao, MD, PhD
The First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan
Yushan Xu, MD, PhD, +8687165324888, xuyushan1019@126.com
Loudi Central Hospital
Loudi, Hunan
Weiping Sun, MD, PhD, +867388527739, sunwp07@163.com
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan
Hongwei Jiang, MD, PhD, +8637964922216, jianghw@haust.edu.cn
Sir Run Run Hospital, Nanjing Medical University
Nanjing, Jiangsu
Yu Liu, +862587115593, hhm0403@163.com
Quanzhou First Hospital, Fujian
Quanzhou, Fujian
Yi Zhang, MD, PhD, +8659522277157, 2005064@163.com
Shanghai Ninth People's Hospital
Shanghai
Jie Qiao, MD, PhD, +862123271699, qiaoj2001@126.com
Tongji Hospital of Tongji University
Shanghai
Shenzhen Bao'an People's Hospital
Shenzhen
Jisu Xue, MD, PhD, +8675527783061, baxjs@126.com
Shenzhen Bao'an Traditional Chinese Medicine Hospital
Shenzhen
Yanping Zheng, MD, M.M., +8675527831439, panyanyes@163.com
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430071
Zhe Dai, MD, PhD, +862767812787, betamm@163.com
Zhe Dai, MD, PhD
The Central Hospital of Xiangtan
Xiangtan, Hunan
Wei Cheng, MD, M.M., +8673158214922, powerchengwei@163.com
The Central Hospital of Yongzhou
Yongzhou, Hunan
Wei Liu, MD, M.M., +867468859487, 786851038@outlook.com
Yueyang People's Hospital
Yueyang, Hunan
Dijun Zhou, MD, PhD, +867308725393, Z121300@126.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Prediabetes
- Being tested
- Chiglitazar sodium, Placebo
- Keywords
- Chiglitazar Sodium, PPAR agonist, Prediabetes, Impaired Glucose Tolerance, Impaired Fasting Glucose, Lifestyle Intervention
- Medical subject headings
- Prediabetic State, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chiglitazar sodiumDrug
Chiglitazar Sodium tablet, 48 mg, oral, once daily, administered from randomization through week 52. Combined with standardized lifestyle intervention provided throughout the study period.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Chiglitazar Sodium + Lifestyle Intervention | Experimental | Participants will receive Chiglitazar Sodium 48 mg orally once daily, combined with standardized lifestyle intervention (diet and exercise counseling), for 52 weeks. Receives: Drug: Chiglitazar sodium |
| Placebo + Lifestyle Intervention | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reversion Rate to Normal Glucose Metabolism
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Measured: Week 64
Secondary outcomes (13)
Reversion Rate to Normal Glucose Metabolism
Proportion of participants achieving reversion to normal glucose metabolism at week 24 and week 52.
Measured: Week 24, Week 52
Progression Rate to Type 2 Diabetes
Proportion of participants progressing to type 2 diabetes at week 24, week 52, and week 64.
Measured: Week 24, Week 52, Week 64
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in fasting plasma glucose level.
Measured: Week 24, Week 52, Week 64
Change From Baseline in OGTT 1-hour and 2-hour Postprandial Glucose (PPG)
Change from baseline in plasma glucose at 1 hour and 2 hours during oral glucose tolerance test.
Measured: Week 24, Week 52, Week 64
Change From Baseline in HbA1c
Change from baseline in glycated hemoglobin level
Measured: Week 24, Week 52, Week 64
Change From Baseline in Lipid Profile
Change from baseline in triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).
Measured: Week 24, Week 52, Week 64
Change From Baseline in Blood Pressure
Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP).
Measured: Week 24, Week 52, Week 64
Change From Baseline in UACR
Change from baseline in urinary albumin-to-creatinine ratio
Measured: Week 24, Week 52, Week 64
Change From Baseline in HOMA-IR
Change from baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR).
Measured: Week 24, Week 52, Week 64
Change From Baseline in HOMA-β
Change from baseline in Homeostatic Model Assessment of β-cell function (HOMA-β).
Measured: Week 24, Week 52, Week 64
Change From Baseline in Body Weight
Change from baseline in body weight
Measured: Week 24, Week 52, Week 64
Change From Baseline in BMI
Change from baseline in body mass index (BMI).
Measured: Week 24, Week 52, Week 64
Change From Baseline in Waist-to-Height Ratio
Change from baseline in waist-to-height ratio.
Measured: Week 24, Week 52, Week 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start18 Apr 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Second Xiangya Hospital of Central South UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 472 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhiguang Zhou, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07558525
- Sponsor's protocol ID
- PRECISE trial
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07558525
- Acronym / sponsor ID
- PRECISE trial
- Conditions
- Prediabetes
- Keywords
- Chiglitazar Sodium, PPAR agonist, Prediabetes, Impaired Glucose Tolerance, Impaired Fasting Glucose, Lifestyle Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 472 participants (estimated)
- Lead sponsor
- Second Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- 18 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chiglitazar Sodium + Lifestyle Intervention | Experimental | Drug: Chiglitazar sodiumParticipants will receive Chiglitazar Sodium 48 mg orally once daily, combined with standardized lifestyle intervention (diet and exercise counseling), for 52 weeks. |
| Placebo + Lifestyle Intervention | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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:
- 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%
- Impaired glucose tolerance (IGT): FPG < 6.1 mmol/L, with 2hPG ≥ 7.8 mmol/L and < 11.1 mmol/L, and HbA1c < 6.5%
- IFG + IGT, with HbA1c < 6.5%
- 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.
Key exclusion criteria (12 listed)
- Use of glucose-lowering medications within 3 months prior to screening.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chiglitazar sodiumChiglitazar Sodium tablet, 48 mg, oral, once daily, administered from randomization through week 52. Combined with standardized lifestyle intervention provided throughout the study period. | Drug | Chiglitazar Sodium + Lifestyle Intervention |
| PlaceboMatching 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. | Drug | Placebo + Lifestyle Intervention |
Primary outcome
Reversion Rate to Normal Glucose Metabolism
Time frame: Week 64
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
13 secondary outcomes
Reversion Rate to Normal Glucose Metabolism
Time frame: Week 24, Week 52
Progression Rate to Type 2 Diabetes
Time frame: Week 24, Week 52, Week 64
Change From Baseline in Fasting Plasma Glucose (FPG)
Time frame: Week 24, Week 52, Week 64
Change From Baseline in OGTT 1-hour and 2-hour Postprandial Glucose (PPG)
Time frame: Week 24, Week 52, Week 64
Change From Baseline in HbA1c
Time frame: Week 24, Week 52, Week 64
Change From Baseline in Lipid Profile
Time frame: Week 24, Week 52, Week 64
Change From Baseline in Blood Pressure
Time frame: Week 24, Week 52, Week 64
Change From Baseline in UACR
Time frame: Week 24, Week 52, Week 64
Change From Baseline in HOMA-IR
Time frame: Week 24, Week 52, Week 64
Change From Baseline in HOMA-β
Time frame: Week 24, Week 52, Week 64
Change From Baseline in Body Weight
Time frame: Week 24, Week 52, Week 64
Change From Baseline in BMI
Time frame: Week 24, Week 52, Week 64
Change From Baseline in Waist-to-Height Ratio
Time frame: Week 24, Week 52, Week 64
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chiglitazar sodium in people with Prediabetes, run by Second Xiangya Hospital of Central South University at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiguang Zhou, MD, PhD (+8673185292154, zhouzhiguang@csu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reversion Rate to Normal Glucose Metabolism (time frame: Week 64). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.