A Randomized, Double-blind, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat

The purpose of this study is to evaluate the Efficacy and Safety of MT921 in Subjects with Moderate to Severe Submental fat compared with Placebo.

Start Date24 Dec 2021

Sponsor / Collaborator

Medytox Inc.

NCT04144049 / CompletedPhase 2

A Randomized, Double-blind, Placebo-controlled, Dose Ranging, Parallel, Multi-center, Phase II Study to Evaluate the Efficacy and Safety of MT921 in Subjects With Moderate to Severe Submental Fat

This study is a randomized, double-blind, placebo-controlled, dose-ranging, parallel, multi-center, phase II study to evaluate the efficacy and safety of MT921 in subjects with moderate to severe submental fat.

Start Date10 Sep 2019

Sponsor / Collaborator

Medytox Inc.

NCT03905291 / CompletedPhase 1

A Randomized, Double-blinded, Placebo-controlled, Single Center, Dose Escalation, Phase I Study to Evaluate the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of MT921 in Healthy Subjects

To determine the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability of MT921 in Healthy Subjects

Start Date31 Jul 2018

Sponsor / Collaborator

Medytox Inc.

100 Clinical Results associated with MT-921

100 Translational Medicine associated with MT-921

100 Patents (Medical) associated with MT-921

Literatures (Medical) associated with MT-921

PharmaceuticalsQ3 · MEDICINE

Evaluation for Potential Drug–Drug Interaction of MT921 Using In Vitro Studies and Physiologically–Based Pharmacokinetic Models

Q3 · MEDICINE

ArticleOA

Author: Yun, Hwi-Yeol ; Kang, Won-Ho ; Lee, Junho ; Ryu, Hyo-Jeong ; Yang, Gi-Hyeok ; Moon, Hyun-Ki ; Yang, Sung-Yoon ; Chae, Jung-Woo

MT921 is a new injectable drug developed by Medytox Inc. to reduce submental fat. Cholic acid is the active pharmaceutical ingredient, a primary bile acid biosynthesized from cholesterol, endogenously produced by liver in humans and other mammals. Although individuals treated with MT921 could be administered with multiple medications, such as those for hypertension, diabetes, and hyperlipidemia, the pharmacokinetic drug–drug interaction (DDI) has not been investigated yet. Therefore, we studied in vitro against drug-metabolizing enzymes and transporters. Moreover, we predicted the potential DDI between MT921 and drugs for chronic diseases using physiologically-based pharmacokinetic (PBPK) modeling and simulation. The magnitude of DDI was found to be negligible in in vitro inhibition and induction of cytochrome P450s and UDP-glucuronosyltransferases. Organic anion transporting polypeptide (OATP)1B3, organic anion transporter (OAT)3, Na+-taurocholate cotransporting polypeptide (NTCP), and apical sodium-dependent bile acid transporter (ASBT) are mainly involved in MT921 transport. Based on the result of in vitro experiments, the PBPK model of MT921 was developed and evaluated by clinical data. Furthermore, the PBPK model of amlodipine was developed and evaluated. PBPK DDI simulation results indicated that the pharmacokinetics of MT921 was not affected by the perpetrator drugs. In conclusion, MT921 could be administered without a DDI risk based on in vitro study and related in silico simulation. Further clinical studies are needed to validate this finding.

PharmaceuticalsQ3 · MEDICINE

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cholic Acid (MT921) after a Subcutaneous Injection in the Submental Area to Humans

Q3 · MEDICINE

ArticleOA

Author: Park, Jin-Woo ; Kim, Kyoung-Ah ; Seo, Soo-Hong ; Lee, Woo-Shun ; Chung, Hyewon ; Kim, Dai-Hyun ; Park, Ji-Young

This study aimed to explore pharmacokinetics, pharmacodynamics, and safety/tolerability of MT921, an injectable cholic acid, after a single subcutaneous administration to healthy volunteers. A randomized, double-blinded, placebo-controlled, single dose-ascending phase 1 study enrolled 24 subjects who were assigned to three groups (60 mg, 120 mg, and 150 mg) of MT921. Blood samples were obtained for a 24-h period before and after injecting MT921 to the submental fat area. Plasma concentrations of cholic acid and deoxycholic acid were determined for pharmacokinetic analysis. Levels of free fatty acid, triglyceride, and total cholesterol were measured for pharmacodynamic analysis. Safety and tolerability were assessed until 21 days post-dose. While systemic exposure to cholic acid tended to increase as the MT921 dose increased, pharmacokinetic profiles of deoxycholic acid were similar among dose groups without showing significant changes. Pharmacodynamic profiles were comparable when measured at baseline and post-dose. The most frequent adverse events were injection site pain and edema. All adverse drug reactions resolved without treatment. MT921 appeared to be well-tolerated after an injection to the submental area at a dose up to 150 mg. Systemic exposure to cholic acid increased as the dose increased. Blood lipid profiles and deoxycholic acid levels were not affected by MT921 treatment.

100 Deals associated with MT-921

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