Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes (NCT07558525) | Clinical Trial Compass
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Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes
China472 participantsStarted 2026-04-18
Plain-language 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. 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓.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.
Exclusion criteria
✕. Use of glucose-lowering medications within 3 months prior to screening.
✕. Major cardiovascular or cerebrovascular events within 6 months prior to screening, defined as:
What they're measuring
1
Reversion Rate to Normal Glucose Metabolism
Timeframe: Week 64
Trial details
NCT IDNCT07558525
SponsorSecond Xiangya Hospital of Central South University
.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).
✕0.History of acute or chronic pancreatitis, or history of gallbladder or bile duct disease (except post-cholecystectomy for gallstones or cholecystitis).
✕1.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.
✕2.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.
✕4.History of malignancy within 5 years prior to screening, or current malignancy.