12 completed, 3 unknown, 1 recruiting. 9 Phase 1, 4 Phase 2, 4 Phase 3, 1 Early Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 9 | Completed 8, Unknown 1 |
| Phase 2 | 4 | Completed 4 |
| Phase 3 | 4 | Completed 2, Unknown 2 |
| Early Phase 1 | 1 | Recruiting 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Single-Center, Open-Label, Single Ascending Dose Study of Exenatide Circular RNA-Lipid Nanoparticle Injection (CR059) in Chinese Subjects With Type 2 Diabetes Mellitus Exenatide Circular RNA-Lipid Nanoparticle Injection（ CR059）） - T2DM | Early Phase 1 | Recruiting | The First Affiliated Hospital of Henan University of Science and Technology | 9 | 2026-01-20 | 2026-04-06 |
| A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-119 Injection in Chinese Obese Subjects PB-119, Placebo - Obesity | Phase 1 / Phase 2 | Completed | PegBio Co., Ltd. | 32 | 2024-05-27 | 2025-11-19 |
| A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PB-718 Injection in Chinese Obese Subjects. PB-718, Placebo - Obesity | Phase 1 / Phase 2 | Completed | PegBio Co., Ltd. | 36 | 2023-07-06 | 2024-04-19 |
| Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy PB-201, PB-201 matched placebo, Metformin hydrochloride - Type 2 Diabetes Mellitus | Phase 3 | Unknown | PegBio Co., Ltd. | 546 | 2022-05-30 | 2022-04-22 |
| Study to Evaluate the Pharmacokinetic Characteristics of Pegylated Exenatide Injection (PB-119) in Subjects With Different Degrees of Renal Insufficiency and Matched Subjects With Normal Renal Function PB119 - Type2Diabetes | Phase 1 | Unknown | PegBio Co., Ltd. | 24 | 2022-05-01 | 2022-04-14 |
| Study to Evaluate the Safety and Efficacy of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus PB-201, Vildagliptin, PB-201 matched placebo - Type 2 Diabetes Mellitus (T2DM) | Phase 3 | Unknown | PegBio Co., Ltd. | 672 | 2021-09-30 | 2022-02-08 |
| A Phase 1, Double-blind, Randomized, Placebo-controlled, Single- and Multiple-dose Escalating Study Placebo, PB 718 - Healthy Subjects | Phase 1 | Completed | PegBio Co., Ltd. | 82 | 2020-07-29 | 2022-09-28 |
| Safety and Efficacy of PB-119 in Subjects With Type 2 Diabetes and Not Well-controlled by Metformin Monotherapy GLP-1 receptor agonist, Placebo - Type 2 Diabetes Mellitus (T2DM) | Phase 3 | Completed | PegBio Co., Ltd. | 620 | 2020-06-23 | 2023-07-28 |
| Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects GLP-1 receptor agonist, Placebo - Type 2 Diabetes Mellitus (T2DM) | Phase 3 | Completed | PegBio Co., Ltd. | 273 | 2020-04-27 | 2023-07-28 |
| Clinical Trial for the Investigational Drug (PB-201) in Subjects With Type 2 Diabetes Mellitus glucokinase activator, Placebo - Type2 Diabetes Mellitus | Phase 1 | Completed | PegBio Co., Ltd. | 16 | 2019-08-27 | 2020-01-22 |
| Dose-finding of PB-119 Administered Subcutaneously Once Weekly Versus Placebo in Subjects With Type 2 Diabetes PB-119 100 μg+ Glucophage®, PB-119 150 μg+ Glucophage®, PB-119 200 μg+ Glucophage® - Type 2 Diabetes Mellitus (T2DM) | Phase 2 | Completed | PegBio Co., Ltd. | 214 | 2018-06-13 | 2020-01-22 |
| Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects PB-119 75ug, PB-119 150ug, PB-119 200ug - Type 2 Diabetes Mellitus | Phase 2 | Completed | PegBio Co., Ltd. | 251 | 2018-06-05 | 2020-01-22 |
| MAD Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PB-119 to Subjects With T2DM PB-119 injection, PB-119 injection placebo - Type2 Diabetes Mellitus | Phase 1 | Completed | PegBio Co., Ltd. | 40 | 2015-11-24 | 2018-04-20 |
| Clinical Trial for PB-119 in Subjects With Type 2 Diabetes Mellitus Exenatide injection(Byetta), PB-119 injection - Type II Diabetes Mellitus | Phase 1 | Completed | PegBio Co., Ltd. | 36 | 2015-04-08 | 2017-02-23 |
| Continuous Multiple Dose PB-119 Injection in Health Volunteers PB-119 injection - Type2 Diabetes Mellitus | Phase 1 | Completed | PegBio Co., Ltd. | 36 | 2014-11-15 | 2017-02-23 |
| Clinical Trial for PB-119 in Healthy Subjects (Phase I) PB-119 - Type II Diabetes | Phase 1 | Completed | PegBio Co., Ltd. | 70 | 2014-02-01 | 2017-02-14 |
Diabetes Mellitus, Type 2 (8) · Obesity (2) · Hypoglycemia (1)
Lead-201 (3) · Metformin (2) · Vildagliptin (1) · glucokinase activator compound 50 (1)
China (13) · United States (3) · Hong Kong (1) · Taiwan (1)
Linong Ji, MD,PhD (2) · Bin Gao, MD,PhD (1) · Bin Gao, MD，PhD (1) · Gregory Tracey, Dr. (1) · Guixia Wang, MD,PhD (1) · Guoping Yang, Ph D (1) · HaiYan Li (1) · Hugh Coleman, MD (1) · Hui Liu, MD，PhD (1) · HuiMin Zhou, MD，PhD (1) · Huige Shao, MD,PhD (1) · Huige Shao, MD，PhD (1) · Jia Miao, MD,PhD (1) · Jianhua Ma, MD,PhD (1)
PMID 30957581, PMID 32006325, PMID 33576936, PMID 33687487, PMID 34805810, PMID 38948164