Shanzeping (prusogliptin) / National Health Research Institutes, CSPC Pharma, Genovate Bio - LARVOL DELTA

A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes (clinicaltrials.gov) - P3 | N=815 | Enrolling by invitation | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study of Prusogliptin Tablets Combined With Dapagliflozin Tablets and Metformin Hydrochloride Extended Release Tablets in Type 2 Diabetes (clinicaltrials.gov) - P3 | N=815 | Not yet recruiting | Sponsor: CSPC Ouyi Pharmaceutical Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetics and Pharmacodynamics of Prusogliptin (DBPR108), a Once-Daily Dipeptidyl Peptidase-4 Inhibitor, in Patients with Type 2 Diabetes. (PubMed, Clin Pharmacokinet) - P1 | "DBPR108 was well tolerated in Chinese patients with type 2 diabetes, and both the pharmacokinetic and pharmacodynamic profiles support once-daily dosage regimens of DBPR108 in future studies."

Journal • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Safety and efficacy of prusogliptin in type-2 diabetes mellitus: a systematic review and meta-analysis of randomized controlled trials. (PubMed, Ir J Med Sci) - "Prusogliptin has a favorable efficacy in attaining glycemic control in patients with T2DM. However, its safety profile yields uncertain outcomes. More literature is required for a definitive result."

Journal • Retrospective data • Review • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Prusogliptin (DBPR108) monotherapy in treatment-naïve patients with type 2 diabetes: A randomized, double-blind, active and placebo-controlled, phase 3 study. (PubMed, Diabetes Obes Metab) - "DBPR108 showed superiority to placebo and non-inferiority to sitagliptin in terms of glycaemic control over the initial 24 weeks in treatment-naïve patients with type 2 diabetes. Furthermore, its efficacy was sustained for up to 52 weeks."

Clinical • Journal • Monotherapy • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects (clinicaltrials.gov) - P1 | N=21 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Completed | Trial primary completion date: Feb 2022 ➔ Jun 2022

Trial completion • Trial primary completion date

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Completed | Trial primary completion date: Feb 2022 ➔ May 2022

Trial completion • Trial primary completion date • Hepatology

A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients (clinicaltrials.gov) - P3 | N=766 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Jun 2024 ➔ Jun 2022 | Trial primary completion date: Apr 2024 ➔ Jun 2022

Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and safety of DBPR108 (prusogliptin) as an add-on to metformin therapy in patients with type 2 diabetes mellitus: A 24-week, multi-center, randomized, double-blind, placebo-controlled, superiority, phase III clinical trial. (PubMed, Diabetes Obes Metab) - "DBPR108 as add-on therapy to metformin offered a significant improvement in glycemic control, was superior to metformin monotherapy (placebo), and was safe and well-tolerated in T2DM patients that is inadequately controlled with metformin."

Clinical • Head-to-Head • Journal • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Enrolling by invitation ➔ Completed

Trial completion • Renal Disease

A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients (clinicaltrials.gov) - P1 | N=30 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Jun 2022 ➔ Mar 2022

Trial completion • Trial completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting ➔ Completed | N=42 ➔ 28

Enrollment change • Trial completion

Mass Balance and Biotransformation Study of [14C]DBPR108 in Human (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Completed; Trial completion date: Mar 2022 ➔ Nov 2021

Clinical • Trial completion • Trial completion date

A Study to Evaluate the Effect of Different Meal Types on the Pharmacokinetics of DBPR108 in Healthy Subjects (clinicaltrials.gov) - P1; N=21; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P1 trial

A Single-dose and Multiple-dose Study to Evaluate the Pharmacokinetics and Pharmacodynamics of DBPR108 Tablets in Type 2 Diabetes Mellitus Patients (clinicaltrials.gov) - P1; N=30; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P1 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects (clinicaltrials.gov) - P1; N=42; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

Mass Balance and Biotransformation Study of [14C]DBPR108 in Human (clinicaltrials.gov) - P1; N=8; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P1 trial

A Study to Evaluate the Efficacy and Safety of DBPR108 100 mg in Type 2 Diabetes Mellitus Patients (clinicaltrials.gov) - P3; N=750; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Drug-drug Interactions (DDIs) of DBPR108 With Warfarin Sodium, Digoxin, Probenecid in Healthy Subjects (clinicaltrials.gov) - P1; N=42; Not yet recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Clinical • New P1 trial

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Renal Impairment (clinicaltrials.gov) - P1; N=40; Enrolling by invitation; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Renal Disease

A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects (clinicaltrials.gov) - P1; N=56; Completed; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Active, not recruiting ➔ Completed; Trial completion date: Mar 2022 ➔ Jul 2021; Trial primary completion date: Feb 2022 ➔ Jul 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date

A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects (clinicaltrials.gov) - P1; N=56; Active, not recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed

A Study of DBPR108 and Metformin Hydrochloride Combination Therapy in Patients With T2DM (clinicaltrials.gov) - P3; N=214; Completed; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Recruiting ➔ Completed; Trial completion date: Dec 2022 ➔ Jun 2021; Trial primary completion date: Sep 2022 ➔ Jun 2021

Clinical • Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate the Pharmacokinetics and Safety of DBPR108 in Subjects With Hepatic Impairment (clinicaltrials.gov) - P1; N=24; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

A Study to Evaluate the DDI of DBPR108 With Metformin,Glibenclamide,Valsartan, or Simvastatin in Healthy Subjects (clinicaltrials.gov) - P1; N=56; Recruiting; Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open