| NCT07284901Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes | HRS9531 Obesity / overweight, Type 2 diabetes | BMI ≥27 | Ph 3 | Recruiting | 49 | Mar 2028 | — | |
| NCT07284875Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes | HRS9531 Obesity / overweight | BMI ≥30 | Ph 3 | Recruiting | 36 | Feb 2028 | — | |
| NCT07458269Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes | HRS9531 Obesity / overweight | BMI ≥35 | Ph 2 | By invitation | 35 | May 2027 | — | |
| NCT07284979Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes | HRS9531, Semaglutide Obesity / overweight | BMI ≥35 | Ph 3 | Recruiting | 32 | Mar 2028 | — | |
| NCT05881837Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes | HRS9531 Obesity / overweight | BMI ≤40 | Ph 2 | Completed | 26 | Oct 2024 | — | |
| NCT06054698Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects | HRS9531 Obesity / overweight | BMI ≤40 | Ph 2 | Completed | 4 | Sep 2024 | — | |
| NCT07660848A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis | HRS9531 MASH / NAFLD / liver fibrosis | BMI ≥24 | Ph 2 | Not yet recruiting | 2 | Mar 2028 | — | |
| NCT07285902A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity | HRS9531, Semaglutide Obesity / overweight | — | Ph 3 | Active, not recruiting | 2 | Mar 2027 | — | |
| NCT07599410A Research Study to Investigate the Efficacy and Safety of HRS9531 Tablets in Participants With Type 2 Diabetes Mellitus | HRS9531 Type 2 diabetes | HbA1c 7.5-10.5% | Ph 2 | Not yet recruiting | 2 | May 2027 | — | |
| NCT06391710HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction | HRS9531 Heart failure, Obesity / overweight | BMI ≥28 | Ph 2 | Active, not recruiting | 1 | Jan 2026 | — | |
| NCT06506175Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects | HRS9531 Healthy volunteers, Obesity / overweight | BMI 24-35 | Ph 1 | Not yet recruiting | 1 | Nov 2024 | — | |
| NCT06649344A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes | HRS9531, Semaglutide Type 2 diabetes | HbA1c ≤11% | Ph 3 | Active, not recruiting | 1 | Sep 2026 | — | |
| NCT06650007the Efficacy and Safety of HRS9531 Injection in Subjects With Type 2 Diabetes， Inadequately Controlled With Diet and Exercise Alone | HRS9531 Type 2 diabetes | HbA1c ≤10% | Ph 3 | Active, not recruiting | 1 | May 2025 | — | |
| NCT06974851A Phase III Study Evaluating the Efficacy and Safety of HRS9531 Injection in Subjects With Obstructive Sleep Apnea (OSA) and Obesity | HRS9531 Obesity / overweight, Sleep apnea | BMI ≥28 | Ph 3 | Recruiting | 1 | Dec 2026 | — | |
| NCT06994650A 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 | HRS9531 Obesity / overweight, Sleep apnea | BMI ≥28 | Ph 3 | Recruiting | 1 | Dec 2026 | — | |
| NCT07150962Relative Bioavailability of First vs Second-Generation Formulations of HRS9531 Tablets in Obese or Overweight Subjects | HRS9531 Obesity / overweight | BMI 24-35 | Ph 1 | Recruiting | 1 | Feb 2026 | — | |
| NCT07540754A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function | HRS9531 Healthy volunteers, Hepatic impairment | BMI 19-40 | Ph 1 | Recruiting | 1 | Jan 2027 | — | |
| NCT07551492A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease | HRS9531 Cardiovascular disease, Obesity / overweight | BMI ≥24 | Ph 3 | Not yet recruiting | 1 | May 2031 | — | |
| NCT07559136A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS9531 Injection in Adolescents With Obesity | HRS9531 Obesity / overweight | BMI 586-2018 | Ph 1 | Not yet recruiting | 1 | Jan 2027 | — | |
| NCT05966272Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects | HRS9531 Type 2 diabetes | HbA1c 7.5-10.5% | Ph 2 | Completed | 1 | Sep 2024 | — | |
| NCT06246175A Study of HRS9531 in Participants With Impaired Kidney Function and Healthy Subjects | HRS9531 Healthy volunteers, Renal impairment | BMI 19-40 | Ph 1 | Completed | 1 | Sep 2025 | — | |
| NCT06287437HRS9531 Controls Weight Regain in Obese Subjects | HRS9531 Obesity / overweight | BMI 30-40 | Ph 2 | Unknown | 1 | Jun 2025 | — | |
| NCT06396429To Compare the Efficacy and Safety of HRS9531 and Placebo in Subjects With Overweight or Obese | HRS9531 Obesity / overweight | BMI ≥28 | Ph 3 | Completed | 1 | Jul 2025 | — | |
| NCT06435676A Study of Single and Multiple Doses HRS9531 Tablets in Healthy Subjects | HRS9531 Healthy volunteers | BMI ≤35 | Ph 1 | Completed | 1 | Oct 2024 | — | |
| NCT06762600A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects | HRS9531 Healthy volunteers | — | Ph 1 | Completed | 1 | Mar 2026 | — | |
| NCT06792955The Evaluation of Bioequivalence Between a Single-dose Pen and a Multi-dose Pen of HRS9531 Injection Solution | HRS9531 Obesity / overweight | — | Ph 1 | Completed | 1 | Jun 2025 | — | |
| NCT06841445Efficacy and Safety of HRS9531 Tablet in Obese Subjects | HRS9531 Obesity / overweight | BMI ≤40 | Ph 2 | Completed | 1 | Jan 2026 | — | |
| NCT06855147Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects | HRS9531 Healthy volunteers | BMI 19-32.5 | Ph 1 | Completed | 1 | Jun 2025 | — | |
| NCT07044401A Single-dose Study to Investigate the Effect of Injection Site on KAI-9531 Relative Bioavailability in a Range of Body Mass Indices | HRS9531 Healthy volunteers, Obesity / overweight | BMI 25-40 | Ph 1 | Completed | 1 | Nov 2025 | — | |
| NCT05152277Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects | HRS9531 Healthy volunteers | BMI 19-35 | Ph 1 | Completed | 1 | Aug 2022 | — | |
| NCT05516966Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Subcutaneous Injections of HRS9531 in Patients With Type 2 Diabetes Mellitus | Dulaglutide, HRS9531 Type 2 diabetes | HbA1c ≤10.5% | Ph 1 | Completed | 1 | May 2023 | — | |
| NCT05893576A Relative Bioavailability Study of HRS9531 in Healthy Subjects | HRS9531 Healthy volunteers | BMI 19-26 | Ph 1 | Completed | 1 | Sep 2023 | — | |
| NCT06654960Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects | HRS9531 Healthy volunteers | BMI 20-30 | Ph 1 | Completed | 1 | Dec 2024 | — | |
| NCT06723691Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects | HRS9531 Healthy volunteers | BMI 24-35 | Ph 1 | Completed | 1 | Jun 2025 | — | |
| NCT07060456Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin | HRS9531 Type 2 diabetes | BMI ≥22 | Ph 3 | Recruiting | 1 | Feb 2027 | — | |
| NCT06565871A Study of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea | HRS9531 Obesity / overweight, Sleep apnea | BMI 24-42 | Ph 2 | Not yet recruiting | 0 | Dec 2025 | — | |
| NCT06595797A 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 | HRS9531 Obesity / overweight, PCOS | BMI ≥28 | Ph 2 | Not yet recruiting | 0 | Dec 2025 | — | |
