Delving into the Latest Updates on DYX116 with Synapse

Overview

Basic Info

Drug Type

Chemical drugs, Peptides

Synonyms

DYX116

Target

GCGR x GIPR x GLP-1R

Action

agonists

Mechanism

GCGR agonists(Glucagon receptor agonists), GIPR agonists(Gastric inhibitory polypeptide receptor agonists), GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

Diabetes MellitusObesityDiabetes Mellitus, Type 2

Inactive Indication-

Originator Organization

Jiangsu Deyuan Pharmaceutical Co., Ltd.

Active Organization

Shenzhen Xingyin Pharmaceutical Co. Ltd.

Jiangsu Deyuan Pharmaceutical Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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主要目的 1）评估健康/超重成人单次皮下注射DYX116后的安全性和耐受性。 2）评估超重/肥胖成人多次皮下注射DYX116后的安全性和耐受性。次要目的 1）评估单次或多次皮下注射DYX116后的药代/药效动力学特征。 2）评估健康/超重/肥胖成人皮下注射DYX116对QTc间期的影响。 3）评估健康/超重/肥胖成人皮下注射DYX116后的免疫原性。

[Translation]

Primary objectives 1) To evaluate the safety and tolerability of DYX116 after a single subcutaneous injection in healthy/overweight adults. 2) To evaluate the safety and tolerability of DYX116 after multiple subcutaneous injections in overweight/obese adults. Secondary objectives 1) To evaluate the pharmacokinetic/pharmacodynamic characteristics of DYX116 after single or multiple subcutaneous injections. 2) To evaluate the effect of subcutaneous injection of DYX116 on the QTc interval in healthy/overweight/obese adults. 3) To evaluate the immunogenicity of DYX116 after subcutaneous injection in healthy/overweight/obese adults.

Start Date02 Apr 2025

Sponsor / Collaborator

Jiangsu Deyuan Pharmaceutical Co., Ltd.

CTR20261893

/ Not yet recruitingPhase 2

评价DYX116在2型糖尿病参与者中多次给药的有效性、安全性及药代动力学特征的随机、双盲、安慰剂及阳性药平行对照II期临床研究

[Translation] A randomized, double-blind, placebo and active-drug parallel-controlled phase II clinical trial evaluating the efficacy, safety and pharmacokinetic characteristics of DYX116 with multiple doses in participants with type 2 diabetes.

主要目的：初步评价不同剂量DYX116在饮食和运动血糖控制不佳的中国2型糖尿病参与者中的有效性。次要目的: 初步评价不同剂量DYX116在饮食和运动血糖控制不佳的中国2型糖尿病参与者中的安全性、耐受性；评价不同剂量DYX116在饮食和运动血糖控制不佳的中国2型糖尿病参与者中的药代动力学（PK）特征；初步评价不同剂量DYX116在饮食和运动血糖控制不佳的中国2型糖尿病参与者中的免疫原性特征。

[Translation]

Primary Objective: To preliminarily evaluate the efficacy of different doses of DYX116 in Chinese participants with type 2 diabetes whose glycemic control is inadequate through diet and exercise. Secondary Objectives: To preliminarily evaluate the safety and tolerability of different doses of DYX116 in Chinese participants with type 2 diabetes whose glycemic control is inadequate through diet and exercise; to evaluate the pharmacokinetic (PK) characteristics of different doses of DYX116 in Chinese participants with type 2 diabetes whose glycemic control is inadequate through diet and exercise; to preliminarily evaluate the immunogenicity characteristics of different doses of DYX116 in Chinese participants with type 2 diabetes whose glycemic control is inadequate through diet and exercise.

Start Date-

Sponsor / Collaborator

Jiangsu Deyuan Pharmaceutical Co., Ltd.

CTR20261894

/ Not yet recruitingPhase 2

评价DYX116在中国成年非糖尿病的超重或肥胖参与者中的有效性、安全性及药代动力学特征的随机、双盲、安慰剂平行对照、多中心II期临床研究

[Translation] A randomized, double-blind, placebo-controlled, parallel-center phase II clinical trial evaluating the efficacy, safety, and pharmacokinetic characteristics of DYX116 in overweight or obese non-diabetic adults in China.

主要目的：初步评价不同剂量DYX116相比于安慰剂在中国成年非糖尿病的超重或肥胖参与者中的有效性。次要目的: 初步评价不同剂量DYX116相比于安慰剂在中国成年非糖尿病的超重或肥胖参与者中的安全性、耐受性；评价不同剂量DYX116相比于安慰剂在中国成年非糖尿病的超重或肥胖参与者中的药代动力学（PK）特征；初步评价不同剂量DYX116在中国成年非糖尿病的超重或肥胖参与者中的免疫原性特征。

[Translation]

Primary Objective: To preliminarily evaluate the efficacy of different doses of DYX116 compared to placebo in overweight or obese non-diabetic adults in China. Secondary Objectives: To preliminarily evaluate the safety and tolerability of different doses of DYX116 compared to placebo in overweight or obese non-diabetic adults in China; to evaluate the pharmacokinetic (PK) characteristics of different doses of DYX116 compared to placebo in overweight or obese non-diabetic adults in China; to preliminarily evaluate the immunogenicity characteristics of different doses of DYX116 in overweight or obese non-diabetic adults in China.

Start Date-

Sponsor / Collaborator

Jiangsu Deyuan Pharmaceutical Co., Ltd.

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100 Clinical Results associated with DYX116

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100 Translational Medicine associated with DYX116

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100 Patents (Medical) associated with DYX116

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100 Deals associated with DYX116

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus	Phase 2	China	Shenzhen Xingyin Pharmaceutical Co. Ltd.	18 May 2026
Obesity	Phase 2	China	Shenzhen Xingyin Pharmaceutical Co. Ltd.	18 May 2026
Obesity	Phase 2	China	Jiangsu Deyuan Pharmaceutical Co., Ltd.	18 May 2026
Diabetes Mellitus, Type 2	Phase 2	China	Jiangsu Deyuan Pharmaceutical Co., Ltd.	13 May 2026