HRS-1780 / Jiangsu Hengrui Pharma - LARVOL DELTA

Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=181 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Evaluating the Efficacy and Safety of HRS-1780 Tablets in Patients with CKD (KIDNEY WEEK 2025) - "The incidence of hyperkalaemia (defined by serum K + > 5.5 mmol/L) was 4.5% and 15.6% with HRS-1780 10 mg and 20 mg groups, respectively. Conclusion Treatment of HRS-1780 showed good efficacy and safety profile in CKD patients."

Clinical • Late-breaking abstract • P2 data • Chronic Kidney Disease • Type 2 Diabetes Mellitus

Pharmacokinetics and Safety of HRS-1780 in Renal Impaired Subjects: A Multicenter, Non-Randomized, Open-Label Study. (PubMed, Drug Des Devel Ther) - "HRS-1780 PK and safety profiles did not differ significantly between healthy and renal impairment subjects. This supports the drug dose regimen for renal impairment patients in clinical practice."

Clinical • Journal • PK/PD data • Chronic Kidney Disease • Nephrology • Renal Disease

Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=181 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Dec 2024 ➔ Mar 2025

Enrollment closed • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

A four-in-one first-in-human study to assess safety, tolerability, pharmacokinetics, pharmacodynamics, and concentration-QTc relationship of HRS-1780, a selective non-steroidal mineralocorticoid receptor antagonist, in healthy men. (PubMed, Expert Opin Investig Drugs) - P1 | "HRS-1780 had favorable safety and pharmacokinetics profiles and did not cause clinically meaningful QTcF prolongation. : ClinicalTrials.gov (NCT05638126)."

Journal • P1 data • PK/PD data

Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

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

Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Chronic Kidney Disease • Nephrology • Renal Disease

Drug-drug Interaction Study of HRS-1780 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=28 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Chronic Kidney Disease • Nephrology • Renal Disease

Safety and Tolerance of Increased Doses of HRS-1780 Tablets in Healthy Subjects (clinicaltrials.gov) - P1 | N=96 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Jun 2023 ➔ Dec 2023 | Trial primary completion date: May 2023 ➔ Dec 2023

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Kidney Disease • Nephrology • Renal Disease

Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function (clinicaltrials.gov) - P1 | N=27 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Chronic Kidney Disease • Nephrology • Renal Disease