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.
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.
Use of glucose-lowering medications within 3 months prior to screening.
Parallel
Chiglitazar sodium
DrugChiglitazar Sodium tablet, 48 mg, oral, once daily, administered from randomization through week 52. Combined with standardized lifestyle intervention provided throughout the study period.
Placebo
DrugMatching 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.
Reversion Rate to Normal Glucose Metabolism
Proportion of participants achieving reversion to normal glucose metabolism at week 64.
Reversion Rate to Normal Glucose Metabolism
Proportion of participants achieving reversion to normal glucose metabolism at week 24 and week 52.
Progression Rate to Type 2 Diabetes
Proportion of participants progressing to type 2 diabetes at week 24, week 52, and week 64.
Change From Baseline in Fasting Plasma Glucose (FPG)
Change from baseline in fasting plasma glucose level.
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.
Change From Baseline in Inflammatory Markers
Change from baseline in high-sensitivity C-reactive protein (hsCRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α).
Incidence of Composite Cardiovascular Event
Incidence of non-fatal myocardial infarction, non-fatal stroke, cardiovascular death, or heart failure throughout.
Incidence of All-Cause Death
Incidence of all-cause death throughout.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Overall incidence of treatment-emergent adverse events and serious adverse events throughout the study.
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