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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53

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

01 Mar 2025·GUT

Definite benefits of GLP-1 receptor agonists: what is the risk of gastroparesis and lung aspiration?

Article

Author: Camilleri, Michael

01 Feb 2025·EXPERT OPINION ON INVESTIGATIONAL DRUGS

Are glucagon-like peptide-1 (GLP-1) receptor agonists useful in treating Parkinson’s disease (PD)? Does the clinical trial with lixisenatide add anything?

Review

Author: Doggrell, Sheila A

INTRODUCTION:

Parkinson's disease (PD) is a common neurodegenerative disease. Glucagon-like peptide-1 (GLP-1) receptor agonists decrease the incidence of developing PD and are being considered for the treatment of PD.

AREAS COVERED:

A phase 2 clinical trial of lixisenatide, a GLP-1 receptor agonist, in the early stages of PD. The primary endpoint was the MDS-UPDRS part 3 motor changes in score from baseline to 12 months in the on-medication state, and this was improved by lixisenatide. Post hoc subgroup analysis suggested that this effect of lixisenatide was greater in the <60-year-olds than in the ≥60 years. None of the secondary/exploratory mostly non-motor endpoints were significantly altered by lixisenatide.

EXPERT OPINION:

Although the scores between lixisenatide and placebo were statistically significantly different, the difference did not quite reach clinical significance. Lixisenatide, like exenatide, had no effect on the primary or secondary endpoints at 6 months suggesting that any benefits with GLP-1 receptor agonists in PD require long-term treatment. The apparent differences in the two age groups may be due to the bigger deterioration of motor scores in the <60-year-old group. Lixisenatide has promise but does not answer the discussion on GLP-1 receptor agonist treatment for PD.

01 Jan 2025·DIABETES-METABOLISM RESEARCH AND REVIEWS

Searching the Crystal Ball for Tailored GLP‐1 Receptor Agonists Treatment in Type 2 Diabetes and Obesity

Review

Author: Buzzetti, Raffaella ; Saturnino, Asia ; Maddaloni, Ernesto ; Zampetti, Simona

ABSTRACT:

Background:

Glucagon‐like peptide 1 receptor agonists (RA) are novel agents used in the management of type 2 diabetes (T2D) and obesity. Although highly effective, the response to treatment may vary significantly among patients.

Objective:

This perspective review aims to summarise the current knowledge about markers of poor or good response to GLP‐1 RA, highlighting the possibility of tailoring treatment strategies and reducing costs associated with T2D and obesity treatment.

Methods:

A comprehensive literature search was conducted using PubMed, NCBI, and Scopus databases, focussing on studies published between 2016 and 2024 that evaluated factors influencing treatment outcomes with GLP‐1 RA.

Results:

Several markers, including baseline HbA1c levels, ghrelin and glucose‐dependent insulinotropic polypeptide (GIP) levels, specific gut microbiome composition, b‐cell function, and genetic markers, were identified as factors associated with treatment response.

Conclusion:

Understanding predictive markers of response to therapy can enhance precision‐based medicine for the selection of patients eligible for GLP‐1 RA, improving clinical outcomes and optimising diabetes management.

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

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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, Type 2	Phase 3	CN	Beijing Lepu Pharmaceutical Technology Co., Ltd.	29 Jan 2023
Obesity	IND Approval	CN	Beijing Lepu Pharmaceutical Technology Co., Ltd.	19 Oct 2021

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


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