Bilessglu (chiglitazar) / Chipscreen - LARVOL DELTA

Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets (clinicaltrials.gov) - P=N/A | N=64 | Completed | Sponsor: Chipscreen Biosciences, Ltd. | Not yet recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets (clinicaltrials.gov) - P=N/A | N=24 | Completed | Sponsor: Chipscreen Biosciences, Ltd. | Not yet recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Venetoclax, Chidamide, and Chiglitazar Sodium (VCC) in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: The First Affiliated Hospital of Xiamen University

New P2 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology

The Effect of Chiglitazar on Pancreatic Islet Function and Metabolism in Patients with Newly Diagnosed Type 2 Diabetes: A Randomized Controlled Open-Label Trial (ChiCTR) - P=N/A | N=50 | Not yet recruiting | Sponsor: Tianjin Medical University General Hospital; Tianjin Medical University General Hospital

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Case report: Tirzepatide-responsive refractory diabetes mellitus in an adult female with prader-willi syndrome. (PubMed, Medicine (Baltimore)) - "This case underscores the importance of considering genetic syndromes in patients with diabetes presenting with early-onset severe obesity and developmental abnormalities and emphasizes the potential therapeutic value of novel antidiabetic agents such as tirzepatide for managing PWS-associated metabolic disturbances. These findings provide important insights into the diagnosis and treatment of diabetes complicated by PWS."

Journal • Developmental Disorders • Diabetes • Genetic Disorders • Mental Retardation • Metabolic Disorders • Obesity • Prader–Willi syndrome • Type 2 Diabetes Mellitus

Pan-PPAR agonists: emerging therapeutic strategies for metabolic dysfunction-associated steatotic liver disease. (PubMed, Metabolism) - "While selective or dual PPAR agonists have reached efficacy plateaus and raised safety concerns in clinical trials, pan-PPAR agonists coordinated activation of all three PPAR isoforms with broader therapeutic efficacy and improved safety profiles. This review delineates the biological rationale for PPAR modulation in MASLD, critically evaluates current preclinical and clinical evidence for pan-PPAR agonists, and discusses emerging strategies for optimizing their development as comprehensive therapeutic interventions for MASLD."

Journal • Review • Hepatocellular Cancer • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Oncology • Solid Tumor

Integrated single-cell multi-omics characterization reveals lipid-associated macrophage-mediated immunosuppression in neoadjuvant immunotherapy of hepatocellular carcinoma. (PubMed, Nat Commun) - P | "We further show the presence, exogenous inducements and immunosuppressive functions of LAM, along with regulation strategies of its lipid-associated condition, including lycopene and chiglitazar...We reveal the TIME components including immunosuppressive LAMs that influence immunotherapy outcomes, thus providing evidence and insights for exploring immune landscape and therapeutic strategies for HCC immunotherapy. ClinicalTrials.gov ID: NCT06571396."

IO biomarker • Journal • Hepatocellular Cancer • Oncology • Solid Tumor • APOA1 • C1QA • FABP1

Chiglitazar alleviates cognitive dysfunction in diabetic mice by restoring mitochondrial function via the PPARs/Nrf2 signaling pathway. (PubMed, Metab Brain Dis) - "Chiglitazar regulates the PPARs/Nrf2 pathway and reverses mitochondrial dysfunction to improve cognitive function in diabetic mice."

Journal • Preclinical • Alzheimer's Disease • Cognitive Disorders • Diabetes • Metabolic Disorders • PPARA • TFAM

Case Report: Early-onset euglycemic diabetic ketoacidosis following henagliflozin initiation in a treatment-naive patient. (PubMed, Front Endocrinol (Lausanne)) - "A 40-year-old woman with newly diagnosed type 2 diabetes (HbA1c 12.9%) was initiated on metformin, henagliflozin (SGLT2 inhibitor), and chiglitazar. In treatment-naive patients initiating SGLT2 inhibitor-based combination therapy, common metformin-associated gastrointestinal symptoms (10-30% of initiants) can precipitate severe euDKA within days through reduced oral intake and dehydration. Although these are well-recognized precipitants, this case underscores the vulnerability of treatment-naive patients to routine adverse effects during the critical initial phase, highlighting the need for stepwise drug initiation, explicit sick-day education, and scheduled early follow-up."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Therapeutic activation of PPARα contributes to NOTCH1 inhibition in T-cell acute lymphoblastic leukemia. (PubMed, BMC Med) - "We conclude that targeting PPARα to suppress T-ALL progression by blocking the NOTCH1 pathway represents a potential novel therapeutic strategy for the treatment of T-ALL."

Journal • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • NOTCH1 • PPARA • STAT3

Synergistic Effects of Dorzagliatin and Chiglitazar on Metabolic in DIO mice with MASLD (ADA 2026) - "Combined dorzagliatin and chiglitazar enhanced glycemic control beyond either agent alone, improving both basal and glucose-stimulated disposal, while partially mitigating chiglitazar-induced body weight gain. Although hepatic histology was unchanged, these findings underscore the potential of this combination to address metabolic dysregulation in MASLD. Further preclinical and clinical studies are warranted to explore the metabolic and hepatic benefits of this dual-mechanism approach."

Late-breaking abstract • Preclinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

CHIG-MASH: A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=300 | Recruiting | Sponsor: Shanghai Jiao Tong University School of Medicine | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus

Drug-Drug Interaction of Chiglitazar with Empagliflozin, Atorvastatin, and Valsartan: An Open-Label, Single-Center, Self-Control, 3-Period Study. (PubMed, Drug Des Devel Ther) - P1 | "Therefore, chiglitazar can be co-administered with these OATP1B1/1B3 substrates without dose adjustments. NCT05681273 (ClinicalTrials.gov)."

Clinical • Journal

Chiglitazar in combination with anti-inflammatory and hepatoprotective therapy for the treatment of MASH associated with T2DM: a prospective, multicentre, randomised, double-blind, placebo-controlled study protocol. (PubMed, BMJ Open) - P2 | "The findings will be disseminated through publication in peer-reviewed journals and presentations at scientific conferences. NCT07303803."

Clinical protocol • Journal • Diabetes • Fibrosis • Hepatology • Immunology • Inflammation • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus

Chiglitazar Added to SGLT-2 Inhibitors for Type 2 Diabetes (clinicaltrials.gov) - P=N/A | N=3550 | Not yet recruiting | Sponsor: Chipscreen Biosciences, Ltd.

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • CST3

Chiglitazar Activates PPAR-α/γ to Suppress Oxidative Stress and Angiogenesis in Corneal Neovascularization. (PubMed, Antioxidants (Basel)) - "Chi primarily activates PPAR-γ and PPAR-α, producing antioxidant and anti-angiogenic benefits, supporting its potential as a multi-target PPAR therapy for CNV."

Journal • Metabolic Disorders • Ophthalmology

Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes (clinicaltrials.gov) - P=N/A | N=472 | Not yet recruiting | Sponsor: Second Xiangya Hospital of Central South University

New trial • Metabolic Disorders

Chiglitazar prevents diabetes-induced skeletal muscle loss by enhancing myogenic differentiation through the MEK/ERK pathway. (PubMed, Biochem Biophys Res Commun) - "In db/db mice, CHI alleviated diabetes-related muscle loss and enhanced grip strength. These results indicate that CHI protects against diabetes-induced muscle loss by promoting myogenic differentiation via the MEK/ERK pathway, supporting its potential as a therapeutic intervention."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Roles of Peroxisome Proliferator-Activated Receptors (PPARs) in Pancreatic Metabolic Diseases. (PubMed, Pharmacol Res) - "Nevertheless, preclinical and clinical studies in this area remain limited, and direct clinical evidence supporting the efficacy of PPAR agonists in pancreatic contexts is currently lacking. Further research is warranted to elucidate the direct therapeutic efficacy of PPAR agonists in pancreatic metabolic diseases."

Journal • Review • Diabetes • Dyslipidemia • Hepatology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Pancreatitis • Type 2 Diabetes Mellitus

Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets (clinicaltrials.gov) - P=N/A | N=64 | Not yet recruiting | Sponsor: Chipscreen Biosciences, Ltd.

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Food Effect and Multiple-Dose Study of Chiglitazar/Metformin Extended-Release Tablets (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Chipscreen Biosciences, Ltd.

New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Dual targeting of PI3Kδ and PPARα enhances antitumor activity via FoxO1 activation in follicular lymphoma. (PubMed, Cell Death Dis) - "Here, we show that combining the PI3Kδ inhibitor linperlisib with the pan-peroxisome proliferator-activated receptor (PPAR) agonist chiglitazar, an agent that reprograms tumor metabolism, delivers robust antitumor activity across FL models, including cell-derived and patient-derived xenografts, with a favorable tolerability profile. Compared with monotherapy, the combination consistently achieves superior tumor control in vivo without overt toxicity, supporting its clinical translation potential. Collectively, these data provide a mechanistic rationale for dual targeting of PI3Kδ and PPARα in FL and advocate for clinical evaluation of this combination with FoxO1 as a pharmacodynamic biomarker."

Journal • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • PIK3CD • PPARA

Pilot Bioequivalence Study of Chiglitazar/Metformin Extended-Release Tablets (clinicaltrials.gov) - P=N/A | N=24 | Not yet recruiting | Sponsor: Chipscreen Biosciences, Ltd.

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Chiglitazar combination with anti-inflammatory and hepatoprotective therapy for the treatment in MASH associated with T2DM: a prospective, multicentre, randomised, double-blind, placebo-controlled study (ChiCTR) - P=N/A | N=300 | Not yet recruiting | Sponsor: Punan Hospital,Pudong New District, Shanghai; Punan Hospital,Pudong New District, Shanghai

New trial • Diabetes • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus

CHIG-MASH: A Study of Chiglitazar in Patients With Metabolic Dysfunction-associated Steatohepatitis and Type 2 Diabetes Mellitus (clinicaltrials.gov) - P2 | N=300 | Not yet recruiting | Sponsor: Shanghai Jiao Tong University School of Medicine

New P2 trial • Diabetes • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Type 2 Diabetes Mellitus