Duvie (lobeglitazone) / Chong Kun Dang - LARVOL DELTA

Effects of Long-Term Lobeglitazone Treatment on Renal Function and Albuminuria in Korean Patients with Type 2 Diabetes Mellitus: A Multicenter Retrospective Observational Study (LUCKY). (PubMed, Diabetes Ther) - "Long-term lobeglitazone treatment was not associated with deterioration of renal function or worsening of albuminuria status across all CKD stages, while demonstrating sustained glycemic efficacy and a favorable safety profile in real-world clinical practice. These findings support lobeglitazone as a clinically relevant long-term treatment option for patients with T2DM, including those with pre-existing CKD."

Journal • Observational data • Retrospective data • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Transcriptomic and metabolomic analyses reveal that lobeglitazone ameliorates hepatic steatosis in rats concurrent with regulation of mitochondrial pyruvate metabolism. (PubMed, Br J Pharmacol) - "Lobeglitazone treatment was associated with improved hepatic steatosis and liver-associated metabolic parameters, accompanied by transcriptional and metabolomic changes related to mitochondrial pyruvate metabolism. These findings are correlative and provide new insights into the hepatic actions of lobeglitazone in metabolic disease."

Journal • Preclinical • Diabetes • Genetic Disorders • Hepatology • Inflammation • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: Aclipse Two Inc. | Recruiting ➔ Completed

Trial completion

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

Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.25/12.5/1000mg in Healthy Volunteers (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Chong Kun Dang Pharmaceutical

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

Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.5/25/1000mg in Healthy Volunteers (clinicaltrials.gov) - P1 | N=31 | Completed | Sponsor: Chong Kun Dang Pharmaceutical

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

Clinical Study to Evaluate the Pharmacokinetics and Safety of CKD-383 0.5/10/1000mg in Healthy Volunteers (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: Chong Kun Dang Pharmaceutical

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

Sodium-glucose cotransporter 2 inhibitor ameliorates thiazolidinedione-induced fluid retention through vascular leakage reduction in white adipose tissue. (PubMed, Diabetes Obes Metab) - "Our results suggest that SGLT2is protect against TZD-induced fluid retention by preserving vascular integrity in WAT, providing a viable therapeutic strategy to minimise TZD-associated side effects."

Journal • Diabetes • Metabolic Disorders • Obesity • CDH5

From Separation to Safety Prediction: Validated RP-HPLC Method for Simultaneous Estimation of Sitagliptin and Lobeglitazone, LC-MS/MS Identification of Degradant Products, and In Silico Safety Profiling. (PubMed, Biomed Chromatogr) - "In silico ADMET and toxicity profiling predicted high gastrointestinal absorption for all degradation products, with PI-1 and PI-2 flagged for carcinogenicity and all except PI-3 showing nephrotoxicity. This integrated analytical-computational approach provides a reliable tool for quality control and safety assessment of this antidiabetic formulation."

Journal • Diabetes • Metabolic Disorders

Lobeglitazone improves glycaemic control as add-on therapy to empagliflozin plus metformin in patients with type 2 diabetes mellitus: A double-blind, randomised, placebo-controlled trial. (PubMed, Diabetes Obes Metab) - "Lobeglitazone as an add-on to empagliflozin and metformin significantly improved glycaemic control in patients with T2DM inadequately controlled on metformin and empagliflozin dual therapy. The treatment was well tolerated, with a low incidence of adverse events."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

LOBEGLITAZONE COMBINED WITH HGF ALLEVIATES FFAS-INDUCED INTRACELLULAR LIPID ACCUMULATION BY MODULATING MITOCHONDRIAL METABOLISM IN HEPG2 CELLS (AASLD 2025) - "Lobeglitazone alone attenuated FFAs-induced intracellular lipid accumulation and favorably modulated PPARα/γ expression and mitochondrial metabolism-related markers, while co-treatment with HGF led to more pronounced effects across these parameters."

Inflammation • CPT1A • HGF • PPARA

Efficacy and durability of early quadruple with lobeglitazone and empagliflozin to uncontrolled type 2 diabetes under metformin and DPP4 inhibitors: 112-week interim results of a 224-week RCT (EASD 2025) - "Early quadruple combination therapy with lobeglitazone and empagliflozin improved glycemic control and insulin resistance without increasing adverse events in people with T2D inadequately controlled with metformin and a DPP4-i."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Aclipse Two Inc. | Not yet recruiting ➔ Recruiting

Enrollment open

Effect of Add-on SGLT2i, TZD, or Combination Therapy in Type 2 Diabetes Patients on DPP4 Inhibitors (clinicaltrials.gov) - P4 | N=100 | Not yet recruiting | Sponsor: Yonsei University

Monotherapy • New P4 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of lobeglitazone added to metformin and sitagliptin combination therapy in patients with type 2 diabetes: A 52-week, multicentre, randomized, placebo-controlled, phase III clinical trial. (PubMed, Diabetes Obes Metab) - "The addition of lobeglitazone in patients with type 2 diabetes inadequately controlled with metformin and sitagliptin is a beneficial therapeutic option, not only providing effective glycaemic control but also improving insulin function such as sensitivity and enhancing certain lipid parameters."

Journal • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Neuroprotective effect of the peroxisome proliferator-activated receptor γ agonist lobeglitazone following intracerebral hemorrhage in rats. (PubMed, Mol Cell Neurosci) - "Regarding functional outcomes, a high dose of lobeglitazone (4 mg/kg) improved the mNSS significantly on days 3 and 13 after ICH. The results suggest that lobeglitazone, a PPARγ agonist, has potential neuroprotective effects on ICH by modulating brain edema and brain inflammation via IL-1β-ERK-COX-2 pathway inhibition."

Journal • Preclinical • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Inflammation • IL1B

Pharmacokinetics and Safety of M107 Orally Disintegrating Tablet in Healthy Adults (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Aclipse Two Inc.

New P1 trial

Quantification of Lobeglitazone Sulfate in Bulk and Tablet Dosage Form by a Validated UV Spectroscopy Method: A New Thiazolidinedione Antidiabetic Drug. (PubMed, Drug Metab Bioanal Lett) - "The developed analytical method has been found to be valuable in regular quality control analysis of lobeglitazone sulfate in pharmaceutical industries. The adopted approach of the developed method has been found to be facile, accurate, precise, and economical."

Journal • Asthma • Diabetes • Immunology • Inflammation • Metabolic Disorders • Pulmonary Disease • Respiratory Diseases • Type 2 Diabetes Mellitus

Bridging the Gap: Eco-Friendly HPLC Analysis of Metformin and Lobeglitazone Sulfate Despite Polarity and Dosage Differences. (PubMed, Biomed Chromatogr) - "The method was also assessed for greenness using a AGREE tool, achieving a score of 0.68, demonstrating its eco-friendly nature. Overall, this method is suitable for the routine analysis of these drugs in pharmaceutical formulations."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Clinical Trial to Compare and Evaluate the Safety and Pharmacokinetic of CKD-501, D745, and D150 for Healthy Subjects in Fed State. (clinicaltrials.gov) - P1 | N=45 | Completed | Sponsor: Chong Kun Dang Pharmaceutical

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

To Evaluate the Food Effect on Pharmacokinetic Profiles and Safety in Healthy Volunteers (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Chong Kun Dang Pharmaceutical

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

A Real-World, Multicentre, Retrospective, Observational Study to Evaluate the Effectiveness and Safety of Lobeglitazone in Type 2 Diabetes Mellitus Patients in India (LODIAB INDIA) (ADA 2024) - "Lobeglitazone significantly improved glycemic parameters, Sr. creatinine, Sr. bilirubin and total cholesterol levels and was well tolerated in Indian Type 2 diabetes patients in the real world setting.Figure 1: Graphical Representation of change in HbA1c% at week12Table 1: Changes in glycemic, lipid, liver and renal parameters from baseline to week12"

Observational data • Real-world • Real-world evidence • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Effect of Lobeglitazone, a Novel Thiazolidinedione, on Liver Fat in Patients with Type 2 Diabetes and Metabolic Dysfunction–Associated Steatotic Liver Disease (MASLD)—A Randomized Controlled Trial (Lobe-MASLD Trial) (ADA 2024) - "Older thiazolidinediones including pioglitazone have concerns in use like impact on bone health. Lobeglitazone reduces liver fat and improves ALT levels in patients with T2DM and MASLD. This benefit was seen even in absence of concurrent use of sglt2 inhibitors or glucagon-like peptide 1 receptor agonists."

Clinical • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Randomized, Double-blind, Phase III Trial of Lobeglitazone Add-on to Metformin in Type 2 Diabetes (SENSITIZE INDIA). (PubMed, J Assoc Physicians India) - "Lobeglitazone 0.5 mg once daily was found to be efficacious and safe in the treatment of T2DM in the Indian population. Lobeglitazone significantly improved glycemic parameters and was noninferior to pioglitazone; hence, it could be a promising insulin sensitizer in T2DM management in India."

Clinical • Journal • P3 data • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

B. longum CKD1 enhances the efficacy of anti-diabetic medicines through upregulation of IL- 22 response in type 2 diabetic mice. (PubMed, Gut Microbes) - "In this study, we investigated the synergistic potential of combining the effects of Bifidobacterium longum NBM7-1 (CKD1) with anti-diabetic medicines, LobeglitazoneⓇ (LO), SitagliptinⓇ (SI), and MetforminⓇ (Met), to alleviate hyperglycemia in a diabetic mouse model...This study advances our understanding of the intricate relationship between gut microbiota and metabolic disorders. We expect this study to contribute to developing a prospective therapeutic strategy modulating the gut microbiota."

Journal • Preclinical • Diabetes • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • IL22