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Oral / Subcutaneous · GLP-1 / GIP dual

HRS9531

38 trials in this molecule. Source: ClinicalTrials.gov, as of July 6, 2026.

Trials

38

Ongoing

21

Recruiting

8

Completed

16

Sites

169

Countries

6

Endpoints

480

Composite endpoints

13

Distinct sites and countries across this molecule's trials. A site running several of its trials counts once, matching the map.

Where the program stands

Trials by phase

Phase 1
15
Phase 2
11
Phase 3
12

Trials by status

Not yet recruiting
8
By invitation
1
Recruiting
8
Active, not recruiting
4
Completed
16
Unknown
1

Evidence coverage

What this asset has been measured on

Endpoints grouped into outcome categories, ranked by how often they are measured across this asset's trials.

Safety / tolerability / PK
163
Weight & body composition
106
Cardiometabolic biomarkers
60
Glycemic / diabetes
58
Patient-reported / QoL
33
Other clinical outcomes
19
Other (unclassified)
11
Cardiovascular outcomes
9
Heart failure
9
MASH / liver
6
Renal / kidney
6

Top 20 metrics across this asset's endpoints

Treatment-emergent AEs (any)Safety/PK

30

AUC₀-∞Safety/PK

29

Body weight, % changeWeight

21

Body weight, absolute change (kg)Weight

21

Fasting glucose, changeGlycemic

20

TmaxSafety/PK

19

Immunogenicity (ADA)Safety/PK

18

CmaxSafety/PK

16

HbA1c, changeGlycemic

14

Waist circumference, changeWeight

13

BMI, changeWeight

12

≥5% weight-loss respondersWeight

10

Half-lifeSafety/PK

9

Total cholesterol, changeBiomarker

9

≥10% weight-loss respondersWeight

7

Triglycerides, changeBiomarker

7

HbA1c <7.0% achievementGlycemic

6

AHI, changeOther clin.

6

HDL-C, changeBiomarker

6

LDL-C, changeBiomarker

5

Programs for this asset

Every trial for this molecule, with the same search, filters, and sort as the Trials tab.

38 of 38

GLP-1 and incretin trials
Asset / PopulationEligibility highlightEvidence
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 ≥27Ph 3Recruiting51Mar 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 ≥30Ph 3Recruiting36Feb 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 ≥35Ph 2By invitation35May 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 ≥35Ph 3Recruiting32Mar 2028-
NCT05881837Efficacy and Safety of HRS9531 Injection in Obese Subjects Without Diabetes

HRS9531

Obesity / overweight

BMI ≤40Ph 2Completed26Oct 2024-
NCT06054698Efficacy and Safety of HRS9531 Injections in Overweight or Obese Subjects

HRS9531

Obesity / overweight

BMI ≤40Ph 2Completed4Sep 2024-
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 2Not yet recruiting2May 2027-
NCT07660848A Study of HRS-4729 Injection and HRS9531 Injection in Participants With Metabolic Dysfunction-Associated Steatohepatitis

HRS9531

MASH / NAFLD / liver fibrosis

BMI ≥24Ph 2Not yet recruiting2Mar 2028-
NCT07285902A Study Comparing the Efficacy and Safety of HRS9531 Injection With Semaglutide Injection in Subjects With Obesity

HRS9531, Semaglutide

Obesity / overweight

-Ph 3Active, not recruiting2Mar 2027-
NCT07670884A Clinical Study to Evaluate the Efficacy and Safety of HRS9531 Tablets in Overweight or Obese Subjects

HRS9531

Obesity / overweight

BMI ≥28Ph 3Not yet recruiting2Jul 2027-
NCT05152277Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HRS9531 in Healthy Subjects

HRS9531

Healthy volunteers

BMI 19-35Ph 1Completed1Aug 2022-
NCT06723691Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects

HRS9531

Healthy volunteers

BMI 24-35Ph 1Completed1Jun 2025-
NCT06855147Mass Balance Study of [14C]HRS9531 in Healthy Male Subjects

HRS9531

Healthy volunteers

BMI 19-32.5Ph 1Completed1Jun 2025-
NCT06654960Influence of HRS9531 on Pharmacokinetics of Metformin in Healthy Subjects

HRS9531

Healthy volunteers

BMI 20-30Ph 1Completed1Dec 2024-
NCT06391710HRS9531 Injection in Obese Subjects With Heart Failure With Preserved Ejection Fraction

HRS9531

Heart failure, Obesity / overweight

BMI ≥28Ph 2Active, not recruiting1Jan 2026-
NCT05966272Efficacy and Safety of HRS9531 Injection in Type 2 Diabetes Subjects

HRS9531

Type 2 diabetes

HbA1c 7.5-10.5%Ph 2Completed1Sep 2024-
NCT07540754A Study to Evaluate the Pharmacokinetics of HRS9531 Injection in Participants With Mild, Moderate, and Normal Hepatic Function

HRS9531

Healthy volunteers, Hepatic impairment

BMI 19-40Ph 1Recruiting1Jan 2027-
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 1Completed1May 2023-
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 3Active, not recruiting1May 2025-
NCT07551492A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease

HRS9531

Cardiovascular disease, Obesity / overweight

BMI ≥24Ph 3Not yet recruiting1May 2031-
NCT06841445Efficacy and Safety of HRS9531 Tablet in Obese Subjects

HRS9531

Obesity / overweight

BMI ≤40Ph 2Completed1Jan 2026-
NCT06762600A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects

HRS9531

Healthy volunteers

-Ph 1Completed1Mar 2026-
NCT07060456Efficacy and Safety of HRS9531 in Participants With Type 2 Diabetes Treated With Basal Insulin

HRS9531

Type 2 diabetes

BMI ≥22Ph 3Recruiting1Feb 2027-
NCT06506175Investigation of Optimal Dosage Regimen for HRS9531 Tablets in Healthy Subjects

HRS9531

Healthy volunteers, Obesity / overweight

BMI 24-35Ph 1Not yet recruiting1Nov 2024-
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 ≥28Ph 3Recruiting1Dec 2026-

Showing 1-25 of 38 trials