HRS9531
Sponsors
Fujian Shengdi Pharmaceutical Co., Ltd., Shanghai Zhongshan Hospital
Conditions
Atherosclerotic Cardiovascular DiseaseBstructive Sleep Apnea (OSA) and ObesityDiabetes Mellitus, Type 2Heart Failure With Preserved Ejection FractionObese Subjects With Polycystic Ovary Syndrome (PCOS)ObesityOverweight or Obesity; Type 2 DiabetesSubjects With Moderate-to-severe OSA and Obesity Who Are on PAP Therapy
Phase 1
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects
CompletedNCT05152277
Start: 2021-12-06End: 2022-08-24Updated: 2022-09-19
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus
CompletedNCT05516966
Start: 2022-10-12End: 2023-05-24Updated: 2024-11-15
A Relative Bioavailability Study of HRS9531 in Healthy Subjects
CompletedNCT05893576
Start: 2023-05-15End: 2023-09-04Updated: 2023-10-24
A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects
CompletedNCT06246175
Start: 2024-02-28End: 2025-09-02Updated: 2026-05-05
A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects
CompletedNCT06435676
Start: 2024-06-04End: 2024-10-08Updated: 2025-05-22
Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects
CompletedNCT06723691
Start: 2024-12-18End: 2025-06-09Updated: 2025-06-22
Phase 2
HRS9531 Controls Weight Regain in Obese Subjects
Active, not recruitingNCT06287437
Start: 2024-01-01End: 2025-12-31Target: 72Updated: 2024-03-01
HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction
Active, not recruitingNCT06391710
Start: 2024-05-06End: 2026-01-31Updated: 2025-11-24
A Multicenter, Randomized, Double-blind, Placebo-parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Polycystic Ovary Syndrome
Not yet recruitingNCT06595797
Start: 2024-09-30End: 2025-12-31Target: 144Updated: 2024-09-19
Phase 3
A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity
RecruitingNCT06974851
Start: 2025-07-25End: 2026-12-31Target: 140Updated: 2025-11-17
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity Who Are on Positive Airway Pressure Ventilation (PAP) Therapy
RecruitingNCT06994650
Start: 2025-08-13End: 2027-01-01Target: 140Updated: 2026-01-26
Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin
RecruitingNCT07060456
Start: 2025-07-25End: 2027-03-31Target: 300Updated: 2026-01-02
A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease
RecruitingNCT07551492
Start: 2026-05-29End: 2031-06-28Target: 9262Updated: 2026-09-08