HSK7653 / Haisco - LARVOL DELTA

A Study on Switching From Daily DPP-4 Inhibitor to HSK7653 in Type 2 Diabetes Patients (clinicaltrials.gov) - P2 | N=64 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

HSK7653 in Chinese Patients with Impaired Glucose Tolerance (clinicaltrials.gov) - P2 | N=99 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed

Trial completion

Efficacy and safety of cofrogliptin once every 2 weeks in Chinese patients with type 2 diabetes: A randomized, double-blind, placebo-controlled, phase 3 trial. (PubMed, Diabetes Obes Metab) - P3 | "Cofrogliptin provided glycaemic control over 52 weeks and was generally well tolerated in patients with T2D."

Clinical • Journal • P3 data • Diabetes • Dyslipidemia • Hypoglycemia • Infectious Disease • Metabolic Disorders • Nephrology • Respiratory Diseases • Type 2 Diabetes Mellitus

Concentration-QTc Modeling of the DPP-4 Inhibitor HSK7653 in a First-in-Human Study of Chinese Healthy Volunteers. (PubMed, Clin Pharmacol Drug Dev) - "The result showed that a placebo-corrected Fridericia corrected QT interval (ΔΔQTcF) prolongation higher than 10 milliseconds is unlikely at the mean maximum observed concentration (Cmax) (411 ng/mL) associated with the recommended therapeutic doses (25 mg twice-monthly), even at the highest supratherapeutic concentration (2425 ng/mL). Thus, HSK7653 does not significantly affect QT prolongation at either recommended doses or the highest supratherapeutic concentration."

Journal • P1 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Biotransformation and disposition characteristics of HSK7653, a novel long-acting dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. (PubMed, Diabetes Obes Metab) - "HSK7653 was well absorbed, slightly metabolized and slowly excreted in humans. The high plasma exposure and long t1/2 of HSK7653 may contribute to its long-lasting efficacy as a long-acting dipeptidyl peptidase-4 inhibitor."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Pharmacokinetics, Pharmacodynamics, and Safety of Single Dose HSK7653 Tablets in Chinese Subjects with Normal or Impaired Renal Function. (PubMed, Clin Pharmacokinet) - P1 | "HSK7653 is a potent oral DPP-4 inhibitor with a long plasma half-life, supporting a dosing regimen of once every 2 weeks. Impaired renal function does not appear to impact the pharmacokinetic and pharmacodynamic properties of HSK7653 after a single administration in Chinese subjects. HSK7653 is also well tolerated without an increase in adverse events with increasing renal impairment. These results indicate that dose adjustment of HSK7653 may not be required in patients with renal impairment."

Journal • PK/PD data • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A model-informed approach to accelerate the clinical development of cofrogliptin (HSK7653), a novel ultralong-acting dipeptidyl peptidase-4 inhibitor. (PubMed, Diabetes Obes Metab) - "Successful waiver approval for the phase 2b dose-finding study was achieved through model-informed recommendations, facilitating the clinical development of HSK7653 and other DPP-4 inhibitors."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, and Dose-Increasing Study on the Safety, Tolerability and PK/PD of Multiple Doses of HSK7653 by Oral Administration in Patients with Type 2 Diabetes Mellitus in China. (PubMed, Diabetes Ther) - "HSK7653 showed desirable pharmacokinetic and pharmacodynamic properties with good safety and tolerability in Chinese T2DM patients. DPP-4 inhibition rate and plasma GLP-1 levels were higher in each dose group than in placebo group."

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

A Study to Evaluate the DDI of HSK7653 With Metformin (clinicaltrials.gov) - P1 | N=22 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

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

Multiple-dose Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Pharmacodynamics of HSK7653 in T2DM (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hsk7653, a novel biweekly DPP-4 inhibitor, versus daily linagliptin as add-on therapy to metformin in Chinese patients with type 2 diabetes (EASD 2023) - P3 | "In Chinese patients with type 2 diabetes who had inadequate glycemic control on metformin monotherapy, the add-on biweekly HSK7653 was non-inferior to daily linagliptin in improving glycemic control with well tolerability and safety."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Single Escalating Dose Study Of HSK7653 In Healthy Subjects (clinicaltrials.gov) - P1 | N=62 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

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

Dose Decision of HSK7653 Oral Immediate Release Tablets in Specific Populations Clinical Trials based on Mechanistic Physiologically-based Pharmacokinetic Model. (PubMed, Eur J Pharm Sci) - "Moreover, two different absorption model development methods (dissolution profile method and the diffusion layer model method) predicted that food had no effect on the exposure of the same simulated population. Since the predicted AUC of HSK7653 at the 10 mg dose in various specific populations was still within the relatively flat results of the exposure-response analysis, the 10 mg dose of HSK7653 was first used to explore the exposure in the renal impairment population (CTR20221952)."

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

HSK7653, a Novel Ultralong-Acting DPP-4 Inhibitor, as Monotherapy in Patients With Type 2 Diabetes—A Randomized, Double-Blind, Placebo-Controlled Phase III Trial (ADA 2023) - P3 | "In people with type 2 diabetes who had inadequate glycemic control on diet and exercise, HSK7653 monotherapy significantly improved glycemic control with well tolerability and safety. Clinical trial information: NCT04556851."

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

"HSK7653 study of long acting DPP4i every TWO weeks demonstrating greater A1c reduction compared to placebo #ADA2023" (@AliceYYCheng)

Clinical • Metabolic Disorders

Development and validation of an HPLC coupled with tandem mass spectrometry method for the determination of HSK7653, a novel super long-acting dipeptidyl peptidase-4 inhibitor, in human plasma and urine and its application to a pharmacokinetic study. (PubMed, Biomed Chromatogr) - "In addition, the precisions of inter- and intra-run of HSK7653 were less than 12.7% and the accuracies were -3.3% to 6.3% for both plasma and urine. Finally, this method was successfully applied to explore the pharmacokinetic characteristics of HSK7653 in Chinese healthy volunteers in a first-in-human study."

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

A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Haisco Pharmaceutical Group Co., Ltd. | Recruiting ➔ Completed | N=64 ➔ 42

Enrollment change • Trial completion • Renal Disease

HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3 | N=465 | Completed | Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd | Recruiting ➔ Completed

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

Mass Balance and Biotransformation of [14C]HSK7653 in Human (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd | Recruiting ➔ Completed

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

HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise (clinicaltrials.gov) - P3 | N=476 | Completed | Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd | Recruiting ➔ Completed

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

A Study to Evaluate the Pharmacokinetics of HSK7653 in Subjects With Renal Impairment (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Haisco Pharmaceutical Group Co., Ltd.

New P1 trial • Renal Disease

HSK7653 in Chinese Patients With Impaired Glucose Tolerance (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Haisco Pharmaceutical Group Co., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open

HSK7653 in Chinese Patients With Impaired Glucose Tolerance (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Clinical • New P2 trial

HSK7653 Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P3; N=450; Recruiting; Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd; Not yet recruiting ➔ Recruiting

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

HSK7653 Treatment in Patients With Type 2 Diabetes Who Are Not Controlled With Diet and Exercise (clinicaltrials.gov) - P3; N=462; Recruiting; Sponsor: Sichuan Haisco Pharmaceutical Group Co., Ltd; Not yet recruiting ➔ Recruiting

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