Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

Starting soon · Not applicable · Has a placebo group

Conditions studied: Prediabetes

In brief

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.

Key facts

Study ID

NCT07558525

Run by

Second Xiangya Hospital of Central South University

People needed

472

Starts

2026-04-18

Expected to finish

2029-12-31

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Use of glucose-lowering medications within 3 months prior to screening.
• Major cardiovascular or cerebrovascular events within 6 months prior to screening, defined as:
• 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).
• 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.
• Severe pulmonary disease with treatments that may potentially affect glucose metabolism (e.g., inhaled corticosteroids, beta-agonists).
• History of acute or chronic pancreatitis, or history of gallbladder or bile duct disease (except post-cholecystectomy for gallstones or cholecystitis).
• 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.
• 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.
• History of malignancy within 5 years prior to screening, or current malignancy.
• 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.
• 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.
• 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.

Where it is running

• Quanzhou First Hospital, Fujian — Quanzhou, Fujian, China
• The First Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China
• The First Hospital of Harbin — Harbin, Heilongjiang, China
• The Second Affiliated Hospital of Harbin Medical University — Harbin, Heilongjiang, China
• The First Affiliated Hospital of Henan University of Science & Technology — Luoyang, Henan, China
• Zhongnan Hospital of Wuhan University — Wuhan, Hubei, China
• The First People's Hospital of Changde City — Changde, Hunan, China
• The Second Xiangya Hospital, Central South University — Changsha, Hunan, China
• Changsha Eighth Hospital — Changsha, Hunan, China
• People's Hospital of Hunan Province — Changsha, Hunan, China
• The Third Xiangya Hospital of Central South University — Changsha, Hunan, China
• Loudi Central Hospital — Loudi, Hunan, China
• The Central Hospital of Xiangtan — Xiangtan, Hunan, China
• The Central Hospital of Yongzhou — Yongzhou, Hunan, China
• Yueyang People's Hospital — Yueyang, Hunan, China
• Sir Run Run Hospital, Nanjing Medical University — Nanjing, Jiangsu, China
• Heji Hospital Affiliated to Changzhi Medical College — Changzhi, Shanxi, China
• The Third People's Hospital of Chengdu — Chengdu, Sichuan, China
• Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital — Chengdu, Sichuan, China
• Chengdu First People's Hospital — Chengdu, Sichuan, China
• The First Affiliated Hospital of Kunming Medical University — Kunming, Yunnan, China
• The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Beijing Tsinghua Changgung Hospital — Beijing, China
• Emergency General Hospital — Beijing, China
• Xuanwu Hospital Capital Medical University — Beijing, China

Full record on ClinicalTrials.gov

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