MedPath

Lobeglitazone

Generic Name
Lobeglitazone
Drug Type
Small Molecule
Chemical Formula
C24H24N4O5S
CAS Number
607723-33-1
Unique Ingredient Identifier
MY89F08K5D
Background

Lobeglitazone is an antidiabetic medication from the thiazolidinedione class of drugs. It primarily functions as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells. By activating PPAR-gamma and promoting the binding of insulin at fat cells, lobeglitazone thereby has been shown to reduce blood sugar levels, lower hemoglobain A1C (HbA1C) levels, and improve lipid and liver profiles . Unlike Pioglitazone, which is a dual PPAR agonist at PPAR-alpha and PPAR-gamma, Lobeglitazone is a pure PPAR-alpha agonist.

Lobeglitazone was approved by the Ministry of Food and Drug Safety (South Korea) in 2013, and is being monitored by postmarketing surveillance until 2019. Lobeglitazone is not approved for use by either the Food and Drug Administration (USA), Health Canada, or by the European Medicines Agency for use in the management of diabetes.

Indication

Lobeglitazone was approved by the Ministry of Food and Drug Safety (South Korea) in 2013, and is being monitored by postmarketing surveillance until 2019. Lobeglitazone is not approved for use by either the Food and Drug Administration (USA), Health Canada, or by the European Medicines Agency for use in the management of diabetes.

Comparison of Dapagliflozin, Lobeglitazone, and Its Combination in Efficacy and Safety

First Posted Date
2023-06-23
Last Posted Date
2023-08-14
Lead Sponsor
Seoul National University Bundang Hospital
Target Recruit Count
99
Registration Number
NCT05915949
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Gyeonggi, Korea, Republic of

A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D759 and D150 (CKD-393)

Phase 1
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: D759, D150
Drug: CKD-501, D759, D150
First Posted Date
2020-06-16
Last Posted Date
2020-11-16
Lead Sponsor
Chong Kun Dang Pharmaceutical
Target Recruit Count
48
Registration Number
NCT04431687
Locations
🇰🇷

CHA Bundang Medical Center, CHA University, Seongnam-si, Bundang, Korea, Republic of

A Clinical Trial to Investigate the Pharmacokinetic Drug Interaction and Safety of CKD-501, D745 and D150

Phase 1
Completed
Conditions
Type 2 Diabetes
Interventions
Drug: D745, D150
Drug: CKD-501, D745, D150
First Posted Date
2020-04-06
Last Posted Date
2020-10-30
Lead Sponsor
Chong Kun Dang Pharmaceutical
Target Recruit Count
48
Registration Number
NCT04334213
Locations
🇰🇷

Severance Hospital, Seoul, Korea, Republic of

Glucose-Lowering Effects and Safety of Adding 0.25 or 0.5 mg Duvie

Phase 4
Completed
Conditions
Type 2 Diabetes Mellitus
Inadequate Glucose Control
Interventions
First Posted Date
2018-12-10
Last Posted Date
2022-01-20
Lead Sponsor
Pusan National University Hospital
Target Recruit Count
159
Registration Number
NCT03770052
Locations
🇰🇷

Pusan National University Hospital, Busan, Korea, Republic of

Evaluate the Drug-drugs Interaction Between Lobeglitazone and Empagliflozin

First Posted Date
2016-08-03
Last Posted Date
2016-08-09
Lead Sponsor
Chong Kun Dang Pharmaceutical
Target Recruit Count
30
Registration Number
NCT02854748
Locations
🇰🇷

Dong A University Hospital, Seo-gu, Busan, Korea, Republic of

Triple Combination Therapy in Type 2 Diabetic Patients Who Had Inadequate Glycemic Control With Combination Therapy

Phase 4
Completed
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2015-01-14
Last Posted Date
2022-01-04
Lead Sponsor
Seoul National University Bundang Hospital
Target Recruit Count
78
Registration Number
NCT02338921
Locations
🇰🇷

Soo Lim, Seongnam, Gyeonggi, Korea, Republic of

Comparison of Lobeglitazone With Pioglitazone as Initial Triple Therapy for Diabetes Management

Phase 4
Conditions
Type 2 Diabetes
Interventions
First Posted Date
2014-12-11
Last Posted Date
2021-03-30
Lead Sponsor
Seoul National University Bundang Hospital
Target Recruit Count
190
Registration Number
NCT02315287
Locations
🇰🇷

Seoul National University Bundang Hospital, Seongnam, Gyeonggi, Korea, Republic of

A 24 Week, Multicenter, Prospective, Open-labeled, Single-arm, Exploratory Phase 4 Clinical Trial to Evaluate the Safety and Efficacy of Lobeglitazone in Decreasing Intrahepatic Fat Contents in Type 2 Diabetes With NAFLD

Phase 4
Completed
Conditions
Type 2 Diabetes
Non-alcoholic Fatty Liver Disease
Interventions
First Posted Date
2014-11-06
Last Posted Date
2016-02-02
Lead Sponsor
Yonsei University
Target Recruit Count
38
Registration Number
NCT02285205
Locations
🇰🇷

Severance Hospital, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of

Comparative Evaluation of Pharmacokinetics After CKD-501 Between Renal Impaired and Normal Renal Function Subjects

Phase 1
Completed
Conditions
Healthy
Renal Impairment
Interventions
First Posted Date
2013-12-11
Last Posted Date
2016-12-06
Lead Sponsor
Chong Kun Dang Pharmaceutical
Target Recruit Count
28
Registration Number
NCT02007941
Locations
🇰🇷

The Inje University Busan Paik Hospital, Busan, Korea, Republic of

A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function

Phase 1
Completed
Conditions
Liver Dysfunction
Interventions
First Posted Date
2013-12-09
Last Posted Date
2016-07-04
Lead Sponsor
Chong Kun Dang Pharmaceutical
Target Recruit Count
26
Registration Number
NCT02005744
Locations
🇰🇷

Yonsei University Severance Hospital, Soeul, Korea, Republic of

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