[Translation] A randomized, double-blind, placebo-controlled phase IIb clinical study to evaluate the efficacy and safety of ABP2111Na tablets in overweight/obese participants

主要目的：评价超重/肥胖参与者口服ABP2111Na片后的有效性；次要目的： 1）评价超重/肥胖参与者口服ABP2111Na片后的安全性； 2）评价超重/肥胖参与者口服ABP2111Na片的群体药代动力学（PK）特征； 3）探索ABP2111Na片治疗超重/肥胖的最佳剂量；探索性目的： 1）探索超重/肥胖参与者口服ABP2111Na片后药效学相关指标的变化； 2）探索超重/肥胖参与者口服ABP2111Na片后对脂肪性肝病相关指标的影响。

[Translation]

Primary purpose: To evaluate the effectiveness of ABP2111Na tablets after oral administration in overweight/obese participants; Secondary purpose: 1) To evaluate the safety of ABP2111Na tablets after oral administration in overweight/obese participants; 2) To evaluate the population pharmacokinetic (PK) characteristics of ABP2111Na tablets after oral administration in overweight/obese participants; 3) To explore the optimal dose of ABP2111Na tablets for the treatment of overweight/obesity; Exploratory purpose: 1) To explore the changes in pharmacodynamic-related indicators after oral administration of ABP2111Na tablets in overweight/obese participants; 2) To explore the effects of ABP2111Na tablets on fatty liver disease-related indicators in overweight/obese participants.

Start Date19 Mar 2025

Sponsor / Collaborator

Shanghai Aibo Pharmaceutical Technology Co Ltd

CTR20243662

/ RecruitingPhase 1

评价ABP2111Na片在2型糖尿病患者中随机、双盲、安慰剂对照的单次、多次给药剂量递增的安全性、耐受性、药代动力学及药效动力学特征的Ib期临床试验

[Translation] A randomized, double-blind, placebo-controlled phase Ib clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple dose escalation of ABP2111Na tablets in patients with type 2 diabetes

主要目的：评价2型糖尿病患者单次与多次口服ABP2111Na片的安全性和耐受性，为本品在II期2型糖尿病患者中的研究推荐剂量范围；次要目的： 1）评价2型糖尿病患者单次与多次口服ABP2111Na片的药代动力学（PK）特征； 2）评价2型糖尿病患者单次与多次口服ABP2111Na片的药效动力学（PD）特征。探索性目的：初步评价2型糖尿病患者口服ABP2111Na片的有效性

[Translation]

Main purpose: To evaluate the safety and tolerability of single and multiple oral administration of ABP2111Na tablets in patients with type 2 diabetes, and to recommend the dosage range for the study of this product in patients with type 2 diabetes in phase II; Secondary purpose: 1) To evaluate the pharmacokinetic (PK) characteristics of single and multiple oral administration of ABP2111Na tablets in patients with type 2 diabetes; 2) To evaluate the pharmacodynamic (PD) characteristics of single and multiple oral administration of ABP2111Na tablets in patients with type 2 diabetes. Exploratory purpose: To preliminarily evaluate the effectiveness of oral administration of ABP2111Na tablets in patients with type 2 diabetes

Start Date29 Sep 2024

Sponsor / Collaborator

Ab Pharma Ltd.

CTR20243414

/ Active, not recruitingPhase 2

评价ABP2111Na片在超重/肥胖受试者中的安全性、耐受性、药代动力学及药效动力学特征的随机、双盲、安慰剂对照、多次给药剂量递增的Ⅱa期临床研究

[Translation] A randomized, double-blind, placebo-controlled, multiple-dose escalation phase IIa clinical study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of ABP2111Na tablets in overweight/obese subjects

主要目的：评价超重/肥胖受试者多次口服ABP2111Na片的安全性和耐受性；次要目的： 1）评价超重/肥胖受试者多次口服ABP2111Na片的药代动力学（PK）特征； 2）评价超重/肥胖受试者多次口服ABP2111Na片药效动力学（PD）； 3）初步探索ABP2111Na片控制体重的有效性，为后期临床研究提供依据； 4）初步评估ABP2111Na片在超重/肥胖受试者的心脏安全性，包括校正QT间期（QTc）延长的可能性，并评估PK/QTc关系。

[Translation]

Main purpose: Evaluate the safety and tolerability of ABP2111Na tablets after multiple oral administration in overweight/obese subjects; Secondary purposes: 1) Evaluate the pharmacokinetic (PK) characteristics of ABP2111Na tablets after multiple oral administration in overweight/obese subjects; 2) Evaluate the pharmacodynamics (PD) of ABP2111Na tablets after multiple oral administration in overweight/obese subjects; 3) Preliminarily explore the effectiveness of ABP2111Na tablets in controlling body weight and provide a basis for later clinical studies; 4) Preliminarily evaluate the cardiac safety of ABP2111Na tablets in overweight/obese subjects, including the possibility of correcting the QT interval (QTc) prolongation, and evaluate the PK/QTc relationship.

Start Date22 Sep 2024

Sponsor / Collaborator

Shanghai Aibo Pharmaceutical Technology Co Ltd

100 Clinical Results associated with ABP2111

100 Translational Medicine associated with ABP2111

100 Patents (Medical) associated with ABP2111

100 Deals associated with ABP2111

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Obesity	Phase 2	China	Shanghai Aibo Pharmaceutical Technology Co Ltd	22 Sep 2024
Diabetes Mellitus, Type 2	Phase 1	China	Ab Pharma Ltd.	03 Jun 2024
Nonalcoholic Steatohepatitis	IND Approval	China	Shanghai Aibo Pharmaceutical Technology Co Ltd	18 Oct 2024

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