Delving into the Latest Updates on Recombinant GLP-1 receptor agonists (Beijing Lepu) with Synapse

主要目的：以北京乐普医药科技有限公司生产的重组GLP-1受体激动剂注射液为试验药，以Vetter Pharma-Fertigung GmbH & Co.KG公司生产的度拉糖肽注射液(商品名：度易达 ® ，TRULICITY ® )为参照药，单次给药后比较试验药与参照药在中国健康受试者体内的药代动力学特征的相似性。次要目的：比较中国健康受试者单次皮下注射试验药和参照药的安全性和免疫原性。

[Translation]

Primary objective: To compare the similarity of the pharmacokinetic characteristics of the test drug and the reference drug in Chinese healthy subjects after a single dose of the recombinant GLP-1 receptor agonist injection produced by Beijing Lepu Pharmaceutical Technology Co., Ltd. as the test drug and the dulaglutide injection (trade name: TRULICITY ® ) produced by Vetter Pharma-Fertigung GmbH & Co.KG as the reference drug. Secondary objective: To compare the safety and immunogenicity of the test drug and the reference drug after a single subcutaneous injection in Chinese healthy subjects.

Start Date06 Oct 2021

Sponsor / Collaborator

Beijing Lepu Pharmaceutical Technology Co., Ltd.

CTR20230029

/ Not yet recruitingPhase 3

比较重组GLP-1受体激动剂注射液与度拉糖肽注射液治疗2型糖尿病的有效性和安全性的多中心、随机、开放、平行对照的III期临床试验

[Translation] A multicenter, randomized, open, parallel-controlled phase III clinical trial comparing the efficacy and safety of recombinant GLP-1 receptor agonist injection and dulaglutide injection in the treatment of type 2 diabetes

主要目的：评价重组 GLP-1 受体激动剂注射液用于治疗 2 型糖尿病的有效性。次要目的：(1) 评价重组 GLP-1 受体激动剂注射液用于治疗 2 型糖尿病的安全性。(2) 评价重组 GLP-1 受体激动剂注射液在 2 型糖尿病患者中的药代动力学特征和免疫原性。

[Translation]

Primary objectives: To evaluate the efficacy of recombinant GLP-1 receptor agonist injection in the treatment of type 2 diabetes. Secondary objectives: (1) To evaluate the safety of recombinant GLP-1 receptor agonist injection in the treatment of type 2 diabetes. (2) To evaluate the pharmacokinetic characteristics and immunogenicity of recombinant GLP-1 receptor agonist injection in patients with type 2 diabetes.

Start Date-

Sponsor / Collaborator

Beijing Lepu Pharmaceutical Technology Co., Ltd.

100 Clinical Results associated with Recombinant GLP-1 receptor agonists (Beijing Lepu)

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100 Translational Medicine associated with Recombinant GLP-1 receptor agonists (Beijing Lepu)

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100 Patents (Medical) associated with Recombinant GLP-1 receptor agonists (Beijing Lepu)

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6

Literatures (Medical) associated with Recombinant GLP-1 receptor agonists (Beijing Lepu)

01 Nov 2022·Deutsche medizinische Wochenschrift (1946)

Behandlungsstrategien bei diabetischer Nephropathie – Update 2022

Article

Author: Artunc, Ferruh ; Schork, Anja

01 Jun 2021·Zeitschrift fur Gastroenterologie

Postoperatives Dumping-Syndrom mit nachhaltiger Störung der Glukosehomöostase – Linderung durch Flash-Glukosemessung und individuelle Indikationsstellung für Glucagon-like-Peptide-1(GLP-1)-Rezeptoragonisten

Article

Author: Leuz, Jule ; Glowka, Tim ; Schmitz, Volker ; Dahlem, Marcus ; Nattermann, Jacob ; Ballmann, Clemens ; Brecht, Laura

01 Sep 2020·Therapeutische Umschau. Revue therapeutique

Update: Neue Therapieformen des Diabetes mellitus Typ 2

Review

Author: Fischli, Stefan

100 Deals associated with Recombinant GLP-1 receptor agonists (Beijing Lepu)

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	Phase 3	China	Beijing Lepu Pharmaceutical Technology Co., Ltd.	29 Jan 2023
Obesity	IND Approval	China	Beijing Lepu Pharmaceutical Technology Co., Ltd.	19 Oct 2021

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2023	Not Applicable	Neoplasms	-	GLP-1 receptor agonists	qyzqdcetnx(tuftcodtpw): HR = 0.36 (95% CI, 0.25 - 0.51) View more	-	04 Apr 2023
				GLP-1 receptor agonists (Non-cancer population)

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Biosimilar

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