Delving into the Latest Updates on Efsubaglutide Alfa with Synapse

Overview

Basic Info

Drug Type

Fusion protein

Synonyms

Efsubaglutide Alfa（Suba）, Supaglutide, 苏帕格鲁肽

+ [7]

Target

GLP-1R

Action

agonists

Mechanism

GLP-1R agonists(Glucagon-like peptide 1 receptor agonists)

Therapeutic Areas

Endocrinology and Metabolic DiseaseDigestive System Disorders

Active Indication

Diabetes Mellitus, Type 2ObesityNonalcoholic Steatohepatitis

Inactive Indication-

Originator Organization

Guangzhou Yinnuo Pharmaceutical Group Co., Ltd.

Active Organization

Innogen Pharmaceutical Technology Co Ltd.

Guangzhou Yinnuo Pharmaceutical Group Co., Ltd.

Inactive Organization-

Drug Highest PhaseApproved

First Approval Date

China (24 Jan 2025),

Diabetes Mellitus, Type 2

RegulationSpecial Review Project (China)

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Structure/Sequence

Sequence Code 1198651119

Source: *****

This is a study to evaluate the impact and efficacy of Efsubaglutide Alfa injection 3mg QoW on the treatment of type 2 diabetes patients with poor glycemic control after dietary and exercise intervention.
Primary objective:
To evaluate the effect and role of continuous treatment with 3mg of Efsubaglutide Alfa QoW and 1mg of Efsubaglutide Alfa QW for 12 weeks on HbA1c in T2DM patients with poor glycemic control after dietary and exercise intervention.
Secondary objectives:
1. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on glucose variability (change in time in range (TIR) relative to baseline) in T2DM patients with poor glycemic control after dietary and exercise intervention.
2. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on drug exposure (relative to 1mg QW) in T2DM patients with poor glycemic control after dietary and exercise intervention.
3. To evaluate the effect of continuous treatment with 3mg of Efsubaglutide Alfa QoW for 12 weeks on fasting plasma glucose (FPG) in T2DM patients with poor glycemic control after dietary and exercise intervention.

Start Date18 Dec 2024

Sponsor / Collaborator

Innogen Pharmaceutical Technology Co Ltd.

CTR20244074

/ RecruitingPhase 2

依苏帕格鲁肽α注射液3mg两周一次给药在饮食和运动干预后血糖控制不佳的2型糖尿病患者中的多中心、随机、对照临床研究

[Translation] A multicenter, randomized, controlled clinical study of esupagglutide α injection 3 mg once every two weeks in patients with type 2 diabetes who have poor glycemic control after diet and exercise intervention

评价依苏帕格鲁肽α注射液3mg两周一次给药（QoW）对饮食和运动干预后血糖控制不佳的2型糖尿病患者（T2DM）治疗的影响和作用。主要目的：在饮食和运动干预后血糖控制不佳的T2DM患者中，评价依苏帕格鲁肽α3mg QoW和1mg QW随机连续治疗12周对HbA1c的影响和作用。次要目的： 1）在饮食和运动干预后血糖控制不佳的T2DM患者中，评价依苏帕格鲁肽α3mg QoW连续治疗12周对患者血糖波动【葡萄糖达标时间百分比（TIR）相对基线的变化】的影响。 2）在饮食和运动干预后血糖控制不佳的T2DM患者中，评价依苏帕格鲁肽α3mg QoW连续治疗12周对药物暴露量的影响（相对 1mg QW）。 3）在饮食和运动干预后血糖控制不佳的T2DM患者中，评价依苏帕格鲁肽α3mg QoW连续治疗12周对空腹血糖（FPG）的影响。

[Translation]

To evaluate the effect and role of esupagglutide α injection 3 mg once every two weeks (QoW) in the treatment of patients with type 2 diabetes (T2DM) with poor glycemic control after diet and exercise intervention. Primary objective: In patients with T2DM with poor glycemic control after diet and exercise intervention, to evaluate the effect and role of esupagglutide α 3 mg QoW and 1 mg QW for 12 weeks of randomized continuous treatment on HbA1c. Secondary objectives: 1) In patients with T2DM with poor glycemic control after diet and exercise intervention, to evaluate the effect of esupagglutide α 3 mg QoW for 12 weeks on patients' blood sugar excursions [changes in percentage of glucose target time (TIR) relative to baseline]. 2) In patients with T2DM with poor glycemic control after diet and exercise intervention, to evaluate the effect of esupagglutide α 3 mg QoW for 12 weeks on drug exposure (relative to 1 mg QW). 3) To evaluate the effect of 12 weeks of continuous treatment with esupagglutide α 3 mg QoW on fasting plasma glucose (FPG) in patients with T2DM who have poor glycemic control after diet and exercise intervention.

Start Date25 Nov 2024

Sponsor / Collaborator

Innogen Pharmaceutical Technology Co Ltd.

[+1]

CTR20240801

/ Active, not recruitingPhase 2

依苏帕格鲁肽α注射液在饮食和运动干预后体重控制不佳的超重及肥胖受试者中多次皮下注射给药的安全性、耐受性、药代动力学和药效学特征的随机、双盲、安慰剂对照IIa期临床研究

[Translation] A randomized, double-blind, placebo-controlled phase IIa clinical study on the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple subcutaneous injections of esupagglutide α in overweight and obese subjects with poor weight control after diet and exercise intervention

评价依苏帕格鲁肽α注射液在饮食和运动干预后体重控制不佳的超重及肥胖受试者中的安全性、耐受性、药代动力学和药效学特征。

[Translation]

To evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of esupagglutide alfa injection in overweight and obese subjects whose weight is poorly controlled after diet and exercise intervention.

Start Date21 Apr 2024

Sponsor / Collaborator

Guangzhou Yinnuo Pharmaceutical Group Co., Ltd.

100 Clinical Results associated with Efsubaglutide Alfa

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100 Translational Medicine associated with Efsubaglutide Alfa

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100 Patents (Medical) associated with Efsubaglutide Alfa

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5

Literatures (Medical) associated with Efsubaglutide Alfa

01 Aug 2022·European Journal of Pharmaceutical Sciences

Pharmacokinetic and pharmacodynamic studies of supaglutide in rats and monkeys

Article

Author: Wang, Zhihong ; Zhang, Li ; Ma, Anran ; Prud'homme, Gerald J ; Liao, Yijing ; Wang, Qinghua ; Liu, Lin ; Zhang, Na ; Zhou, Yue

We demonstrated recently that supaglutide, a novel GLP-1 mimetic generated by recombinant fusion protein techniques, exerted hypoglycemic effects in type 2 diabetes db/db mice and spontaneous diabetic monkeys. In this study, we investigated the pharmacokinetics and pharmacodynamics of supaglutide by single subcutaneous and intravenous injection(s) in rats and rhesus monkeys, as well as fourconsecutive subcutaneous injections in monkeys.We found the half-life (t1/2) of supaglutide was 39.7 h and 35.8 h at dosing 0.1 mg/kg upon subcutaneous or intravenous administration respectively, in rhesus monkeys. The plasma supaglutide peaked at 8-10 h, while the plasma drug exposure levels increased with the increase of dose, showing approximately a linear pharmacokinetic characteristic. The elimination kinetics (Ke) were found to be similar between subcutaneous (∼0.025 in rats and ∼0.018 in monkeys) and intravenous administration (0.021 in rats and 0.020 in monkeys), whereas the bioavailability was found to be 31.1% in rats and 63.9% in monkeys. In monkeys, a single dose injection of supaglutide markedly decreased the random blood glucose levels that reaching the maxima effects in 14-16 h, gradually recovered and returned to the baseline level approximately after 72 h. ¹²⁵I-supaglutide was found mainly distributed in the serum and organs rich in blood supply. Urine was found to be the primary excretion route of supaglutide, following by feces, but mostly not in bile.Our results show that supaglutide possess linear pharmacokinetic characteristics associated with prolonged hypoglycemic effects inanimals,suggestinga potential weekly dosing therapeutic reagent for the treatment of type 2 diabetes and metabolic diseases.

01 Feb 2021·Journal of EndocrinologyQ3 · MEDICINE

Novel GLP-1 analog supaglutide improves glucose homeostasis in diabetic monkeys

Q3 · MEDICINE

Article

Author: Ma, Anran ; Zhao, Ying ; Li, Jia ; Cui, Qiaoli ; Zhou, Quanquan ; Zhang, Li ; Jiang, Yaojing ; Wang, Zhihong ; Liang, Yinan ; Wang, Qinghua ; Shao, Anna ; Tao, Weihong ; Yang, Zunyuan ; Liao, Yijing ; Zeng, Wen ; Yang, Zhenyan ; Huang, Xiaohang ; Wu, Minglin

Glucagon-like peptide 1 (GLP-1) is an insulinotropic hormone and plays an important role in regulating glucose homeostasis. GLP-1 has a short half-life (t1/2 < 2 min) due to degrading enzyme dipeptidyl peptidase-IV and rapid kidney clearance, which limits its clinical application as a therapeutic reagent. We demonstrated recently that supaglutide, a novel GLP-1 mimetic generated by recombinant fusion protein techniques, exerted hypoglycemic and β-cell trophic effects in type 2 diabetes db/db mice. In the present study, we examined supaglutide’s therapeutic efficacy and pharmacokinetics in diabetic rhesus monkeys. We found that a single subcutaneous injection of supaglutide of tested doses transiently and significantly reduced blood glucose levels in a dose-dependent fashion in the diabetic monkeys. During a 4-week intervention period, treatment of supaglutide of weekly dosing dose-dependently decreased fasting and random blood glucose levels. This was associated with significantly declined plasma fructosamine levels. The repeated administration of supaglutide remarkably also decreased body weight in a dose-dependent fashion accompanied by decreased food intake. Intravenous glucose tolerance test results showed that supaglutide improved glucose tolerance. The intervention also showed enhanced glucose-stimulated insulin secretion and improved lipid profile in diabetic rhesus monkeys. These results reveal that supaglutide exerts beneficial effects in regulating blood glucose and lipid homeostasis in diabetic rhesus monkeys.

Frontiers in PhysiologyQ2 · MEDICINE

Novel GLP-1 Analog Supaglutide Reduces HFD-Induced Obesity Associated with Increased Ucp-1 in White Adipose Tissue in Mice

Q2 · MEDICINE

ArticleOA

Author: Wang, Zhihong ; Cui, Qiaoli ; Zhang, Xiangyu ; Wang, Qinghua ; Jiang, Dongdong ; Bao, Xi ; Liu, Rui ; Wan, Yun ; Liu, Wenjuan ; Huang, Jiabao

GLP-1, an important incretin hormone plays an important role in the regulation of glucose homeostasis. However, the therapeutic use of native GLP-1 is limited due to its short half-life. We recently developed a novel GLP-1 mimetics (supaglutide) by genetically engineering recombinant fusion protein production techniques. We demonstrated that this formulation possessed long-lasting GLP-1 actions and was effective in glycemic control in both type 1 and type 2 diabetes rodent models. Here, we investigated the effects of supaglutide in regulating energy homeostasis in obese mice. Mice were fed with high-fat diet (HFD) for 6 months to induce obesity and then subjected to supaglutide treatment (300 μg/kg, bi-weekly for 4 weeks), and placebo as control. Metabolic conditions were monitored and energy expenditure was assessed by indirect calorimetry (CLAMS). Cold tolerance test was performed to evaluate brown-adipose tissue (BAT) activities in response to cold challenge. Glucose tolerance and insulin resistance were evaluated by intraperitoneal glucose tolerance test and insulin tolerance tests. Liver and adipose tissues were collected for histology analysis. Expression of uncoupling protein 1(Ucp1) in adipose tissues was evaluated by Western blotting. We found that supaglutide treatment reduced body weight, which was associated with reduced food intake. Compared to the placebo control, supaglutide treatment improved lipid profile, i.e., significantly decreased circulating total cholesterol levels, declined serum triglyceride, and free fatty acid levels. Importantly, the intervention significantly reduced fatty liver, decreased liver triglyceride content, and concomitantly ameliorated liver injury exemplified by declined hepatic alanine aminotransferase (ALT) and aspartic transaminase (AST) content. Remarkably, supaglutide reduced hepatic lipid accumulation and altered morphometry in favor of small adipocytes in fat. This is consistent with the observation that supaglutide increased tolerance of the mice to cold environment associated with up-regulation of Ucp1 in the inguinal fat. Furthermore, supaglutide improved glucose tolerance, and insulin sensitivity in the obese mice suggesting improved glucose and energy homeostasis. Our findings suggest that supaglutide exerts beneficial effect on established obesity through reducing energy intake and is associated with brown remodeling of white adipose tissue.

100 Deals associated with Efsubaglutide Alfa

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus, Type 2	China	Innogen Pharmaceutical Technology Co Ltd.	24 Jan 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 2	China	Guangzhou Yinnuo Pharmaceutical Group Co., Ltd.	21 Apr 2024
Nonalcoholic Steatohepatitis	Phase 2	United States	Innogen Pharmaceutical Technology Co Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04998032 (EASD2024) Manual	Phase 2	Diabetes Mellitus, Type 2	120	Efsubaglutide Alfa 1 mg + metformin	(hmanxfdrho) = hwsuffecox jahjvgtvms (uboukfewsz, -1.38 to -0.82) View more	Positive	09 Sep 2024
				Efsubaglutide Alfa 3 mg + metformin	(hmanxfdrho) = brioqqgcvd jahjvgtvms (uboukfewsz, -1.70 to -1.16) View more
NCT05694221 (ADA2024) Manual	Phase 1	-	32	Supaglutide+digoxin	(kucgsdjdza) = the coadministration of supa injection had no effect on the AUC0-last of digoxin, a reduction in Cmax by about 24%, and an increase in the AUC0-inf by about 15% compared with that of the digoxin administration alone. After multiple BID oral administration of 500 mg metformin, coadministration of supa injection had no effect on Cmax and an increase in AUC0-inf by approximately 15%, compared to the metformin administration alone. uknmueemqk (rknznxxrlw )	Positive	14 Jun 2024
				Supaglutide+metformin hydrochloride
NCT04998032 (EASD2023)	Phase 3	Diabetes Mellitus, Type 2 Add-on HbA1c	344	Supaglutide 3 mg	(pdqvfuzkyx) = euutjwcguy keiwubrlbl (gkzfytbmri )	Positive	03 Oct 2023
NCT04994288 (ADA2023)	Phase 2/3	Diabetes Mellitus, Type 2	297	Supaglutide 1 mg	(uinrglafuo) = osbrhtfkcl gqgrcnpwuw (zeobzutrxb )	Positive	20 Jun 2023
				Supaglutide 3 mg	(uinrglafuo) = mkdphkiwxh gqgrcnpwuw (zeobzutrxb )
NCT04998032 (ADA2023)	Phase 2/3	Diabetes Mellitus, Type 2 Add-on	340	Supaglutide 3 mg	tbighkcgqi(eqryoyfyvs) = The most common TEAEs with supa were GI symptoms, such as nausea, vomiting, diarrhea and decreased appetite mostly in mild or moderate severity ihlnyeunjm (djgchivdfb ) View more	Positive	20 Jun 2023
ADA2022	Not Applicable	-	48	Supaglutide	(pbcpwghkxp) = uazrxwycoq mhlyvxizdm (nkdvnicjxm ) View more	-	01 Jun 2022

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