Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingNot a traditional drug phaseobservationalRules rewrite
Not a traditional drug phase: testing SGLT-2 inhibitor and Chiglitazar for T2DM (Type 2 Diabetes Mellitus)
The goal of this watch-and-measure (no experimental treatment required) study is to measure the comprehensive clinical how well it works, cardiovascular, renal, and hepatic benefits, as well as the safety of adding Chiglitazar to SGLT-2 inhibitor therapy in adult patients with Type 2 Diabetes Mellitus (T2DM) . The main questions it aims to answer are: What is the real-world effectiveness of Chiglitazar, when added to an SGLT-2 inhibitor, on glycemic control?
Receiving stable-dose SGLT-2 inhibitor this drug alone or in combination with one other oral antidiabetic drug for at least one month prior to screening, but with inadequate glycemic control, defined as HbA1c ≥ 7.5%
Who the registry excludes
Current or routine use of insulin therapy
Use of three or more antidiabetic drugs within one month prior to screening
Current treatment with a thiazolidinedione (TZD) or a GLP-1 receptor agonist (GLP-1 RA)
Prior treatment with Chiglitazar Sodium
Presence of life-threatening comorbidities, severe edema, or severe hepatic impairment (Child-Pugh Class C)
Laboratory findings meeting any of the following criteria: a) Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 5 times the upper limit of normal (ULN); b) Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m²
HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH).
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07580638?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07580638?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.