Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes

NCT07558525 | Not Yet Recruiting DMC

• 1 other identifier: PRECISE trial
• Study Type: interventional
• Target: 472
• Locations: 1 country
• Sites: 30

Brief 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.

Conditions

Prediabetes

Keywords

Chiglitazar Sodium; PPAR agonist; Prediabetes; Impaired Glucose Tolerance; Impaired Fasting Glucose; Lifestyle Intervention

Outcome Measures

Primary Outcomes (1)

• Reversion Rate to Normal Glucose Metabolism

  Proportion of participants achieving reversion to normal glucose metabolism at week 64.

  Week 64

Secondary Outcomes (13)

• Reversion Rate to Normal Glucose Metabolism

  Week 24, Week 52

• Progression Rate to Type 2 Diabetes

  Week 24, Week 52, Week 64

• Change From Baseline in Fasting Plasma Glucose (FPG)

  Week 24, Week 52, Week 64

• Change From Baseline in OGTT 1-hour and 2-hour Postprandial Glucose (PPG)

  Week 24, Week 52, Week 64

• Change From Baseline in HbA1c

  Week 24, Week 52, Week 64

Other Outcomes (4)

• Change From Baseline in Inflammatory Markers

  Week 24, Week 52, Week 64

• Incidence of Composite Cardiovascular Event

  Week 104, Week 156

• Incidence of All-Cause Death

  Week 104, Week 156

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Chiglitazar sodium DRUG

Chiglitazar Sodium tablet, 48 mg, oral, once daily, administered from randomization through week 52. Combined with standardized lifestyle intervention provided throughout the study period.

Chiglitazar Sodium + Lifestyle Intervention

Placebo DRUG

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.

Placebo + Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Second Xiangya Hospital of Central South University: lead

Study Sites (30)

Quanzhou First Hospital, Fujian

Quanzhou, Fujian, China

Location

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

Location

The First Hospital of Harbin

Harbin, Heilongjiang, 150010, China

Location

The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China

Location

The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

Location

The First People's Hospital of Changde City

Changde, Hunan, China

Location

The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China

Location

Changsha Eighth Hospital

Changsha, Hunan, China

Location

People's Hospital of Hunan Province

Changsha, Hunan, China

Location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Loudi Central Hospital

Loudi, Hunan, China

Location

The Central Hospital of Xiangtan

Xiangtan, Hunan, China

Location

The Central Hospital of Yongzhou

Yongzhou, Hunan, China

Location

Yueyang People's Hospital

Yueyang, Hunan, China

Location

Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Location

Heji Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China

Location

The Third People's Hospital of Chengdu

Chengdu, Sichuan, 610036, China

Location

Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

Chengdu First People's Hospital

Chengdu, Sichuan, 610499, China

Location

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, China

Location

Emergency General Hospital

Beijing, China

Location

Xuanwu Hospital Capital Medical University

Beijing, China

Location

The Southwest Hospital of the Army Medical University

Chongqing, 400038, China

Location

Shanghai Ninth People's Hospital

Shanghai, China

Location

Tongji Hospital of Tongji University

Shanghai, China

Location

Shenzhen Bao'an People's Hospital

Shenzhen, China

Location

Shenzhen Bao'an Traditional Chinese Medicine Hospital

Shenzhen, China

Location

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Central Study Contacts

Zhiguang Zhou, MD, PhD

CONTACT

+8673185292154; zhouzhiguang@csu.edu.cn

Chuqing Cao, MD, PhD

CONTACT

+8673185292154; caochuqing@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: April 30, 2026
• Study Start: April 18, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (30)