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A Randomized, Double-blind, Placebo-controlled, Multicenter, Prospective Comparative, Investigator-initiated Clinical Trial to Evaluate the Efficacy of Carnitine Orotate Complex _Godex® in Patients With Nonalcoholic Fatty Liver Disease

the purpose of this clinical trial is to assess the efficacy and safety of Orotic Acid Carnitine Complex Capsules (Godex®) in comparison to a placebo control group in patients with Non-Alcoholic Fatty Liver Disease (NAFLD).

开始日期2023-09-25

申办/合作机构

Seoul National University Hospital

[+1]

NCT03499704 / Active, not recruiting临床4期

A Multicenter, Randomized, Open-label, Two-arm, Phase 4 Study to Evaluate the Effect of Add-on Pioglitazone or Dapagliflozin in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled by Dipeptidyl Peptidase-4 Inhibitor and Metformin Therapy

The purpose of this study is to assess the pioglitazone plus alogliptin plus metformin is non-inferior to dapagliflozin plus alogliptin plus metformin on glycosylated haemoglobin (HbA1c) change from baseline at Week 26.

开始日期2020-02-11

申办/合作机构

Celltrion Pharm Inc.

NCT04470830 / CompletedN/A

Post-Marketing Surveillance (Usage Results Study) of Azilsartan Medoxomil/Chlorthalidone FDC in the Treatment of Patients With Essential Hypertension in South Korea

The purpose of this study is to evaluate the safety by assessing all serious and non-serious adverse events (AEs), irrespective of relatedness or expectedness, as well as other safety parameters including laboratory values, serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected on the precaution in the use, ADRs already known, non-serious ADRs and other safety related information (laboratory values changes, etc).

开始日期2019-09-11

申办/合作机构

Celltrion Pharm Inc.

100 项与 Celltrion Pharm Inc. 相关的临床结果

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0 项与 Celltrion Pharm Inc. 相关的专利（医药）

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1

项与 Celltrion Pharm Inc. 相关的文献（医药）

2015-07-01·Diabetes Care1区 · 医学

Improvement of Nonalcoholic Fatty Liver Disease With Carnitine-Orotate Complex in Type 2 Diabetes (CORONA): A Randomized Controlled Trial

1区 · 医学

Article

作者: Ju, Young Cheol ; Yoon, Kun Ho ; Bae, Ji Cheol ; Lee, Kwan Woo ; Park, Joong Yeol ; Cho, Yoon Young ; Lee, Won Young ; Woo, Jeong Taek ; Lee, Won Jae ; Han, Kyung Ah ; Lee, Moon-Kyu ; Son, Hyun Sik

OBJECTIVEWe aimed to evaluate the effects of carnitine-orotate complex in patients with nonalcoholic fatty liver disease (NAFLD) and diabetes.RESEARCH DESIGN AND METHODSEight hospitals in Korea participated in this randomized, controlled, double-blind trial of patients with diabetes and NAFLD. Seventy-eight patients were randomly assigned in a 1:1 ratio to receive carnitine-orotate complex (824 mg, three times daily) or matching placebo. The primary study outcome was decline in alanine aminotransferase (ALT) to the normal range. Secondary study outcomes were change in ALT, radiological hepatic steatosis, parameters for anthropometry, liver function, lipid profiles, and glycemic control. Hepatic steatosis was assessed using Hounsfield units on noncontrast computed tomography (CT) imaging with hepatic attenuation.RESULTSAfter 12 weeks of treatment, compared with placebo group, carnitine-orotate complex–treated participants had a significantly higher rate of normalization of serum ALT level (17.9% vs. 89.7%, P < 0.001). On hepatic CT analysis, participants treated with carnitine-orotate complex showed an increased liver attenuation index (0.74 ± 8.05 vs. 6.21 ± 8.96, P < 0.008). A significant decrease in HbA1c was observed in the carnitine-orotate complex group (−0.33 ± 0.82% [−3.6 ± 9.0 mmol/mol], P = 0.007), but no significant change was seen in the placebo group.CONCLUSIONSTreatment with carnitine-orotate complex improves serum ALT and may improve hepatic steatosis as assessed by CT in patients with diabetes and NAFLD. Further studies using more advanced magnetic resonance imaging and liver histology as an end point are needed to assess its efficacy in NAFLD.

1

项与 Celltrion Pharm Inc. 相关的新闻（医药）

2023-09-05

·FiercePharma

South Korea's Celltrion earmarks $94.5M for new manufacturing plant: reports

South Korea's Celltrion will spend $94.5 million to build a new manufacturing facility at its Songdu campus near Seoul, according to reports. Celltrion, a South Korea-based biopharma manufacturer, plans to spend 126 million South Korean won ($94.5 million) to build a new production facility, according to local reports. The plant is expected to be completed and operational by 2027 and will be located at the company’s Songdo campus near Seoul, according to the Korea Biomedical Review. The company revealed its expansion plan at the Songdo campus Tuesday, the report said. When completed, the new facility will have an annual production capacity of 8 million vials and will be designed to operate at a high efficiency to reduce operating costs. Celltrion recently announced it would consolidate the Celltrion Healthcare and Celltrion Pharm divisions under the Celltrion umbrella as part of a three-way merger. Before that, back in 2020, Celltrion said it would spend $453 million to construct its third production facility at the Songdo campus. At the time, the company estimated the project would create up to 3,000 new jobs. That same year, Celltrion Chairman Seo Jung-jin announced the company would spend $33.6 billion over a 10-year period to boost its pharma business by investing in biologics operations and ingredient businesses plus artificial intelligence to create an e-commerce market for its drugs. In the latest presentation, Celltrion said the new plant is aimed at addressing growing demand, according to the Korea Biomedical Review.