Prediabetes reversal hope: new drug combo tested in major trial

NCT ID NCT07558525

Disease control Sponsor: Second Xiangya Hospital of Central South University Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a medication called chiglitazar sodium, combined with healthy lifestyle changes, can help people with prediabetes return to normal blood sugar levels. About 472 adults with prediabetes will take either the drug or a placebo for 52 weeks, along with lifestyle coaching. The main goal is to see how many achieve normal glucose metabolism by week 64, and to monitor for progression to type 2 diabetes.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 472 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 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: 1. 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% 2. Impaired glucose tolerance (IGT): FPG \< 6.1 mmol/L, with 2hPG ≥ 7.8 mmol/L and \< 11.1 mmol/L, and HbA1c \< 6.5% 3. IFG + IGT, with HbA1c \< 6.5% 4. 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: 1. Use of glucose-lowering medications within 3 months prior to screening. 2. 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). 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.

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Conditions

The condition(s) this trial relates to.

glucose intolerance prediabetes syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prediabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

30 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

Beijing Tsinghua Changgung Hospital

Beijing, China
Changsha Eighth Hospital

Changsha, Hunan, China
Chengdu First People's Hospital

Chengdu, Sichuan, 610499, China
Emergency General Hospital

Beijing, China
Heji Hospital Affiliated to Changzhi Medical College

Changzhi, Shanxi, China
Loudi Central Hospital

Loudi, Hunan, China
People's Hospital of Hunan Province

Changsha, Hunan, China
Quanzhou First Hospital, Fujian

Quanzhou, Fujian, China
Shanghai Ninth People's Hospital

Shanghai, China
Shenzhen Bao'an People's Hospital

Shenzhen, China
Shenzhen Bao'an Traditional Chinese Medicine Hospital

Shenzhen, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China
Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, China
The Central Hospital of Xiangtan

Xiangtan, Hunan, China
The Central Hospital of Yongzhou

Yongzhou, Hunan, China
The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China
The First Affiliated Hospital of Henan University of Science & Technology

Luoyang, Henan, China
The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China
The First Hospital of Harbin

Harbin, Heilongjiang, 150010, China
The First People's Hospital of Changde City

Changde, Hunan, China
The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China
The Second Affiliated Hospital of Harbin Medical University

Harbin, Heilongjiang, 150086, China
The Second Xiangya Hospital, Central South University

Changsha, Hunan, 410011, China
The Southwest Hospital of the Army Medical University

Chongqing, 400038, China
The Third People's Hospital of Chengdu

Chengdu, Sichuan, 610036, China
The Third Xiangya Hospital of Central South University

Changsha, Hunan, China
Tongji Hospital of Tongji University

Shanghai, China
Xuanwu Hospital Capital Medical University

Beijing, China
Yueyang People's Hospital

Yueyang, Hunan, China
Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 430071, China

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