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Oral · GLP-1 agonist

KAI-7535 / HRS-7535

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

Trials

22

Ongoing

7

Recruiting

3

Completed

13

Sites

40

Countries

2

Endpoints

185

Composite endpoints

0

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
9
Phase 1/2
1
Phase 2
7
Phase 3
5

Trials by status

Not yet recruiting
2
Recruiting
3
Active, not recruiting
2
Completed
13
Unknown
2

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
95
Weight & body composition
35
Glycemic / diabetes
31
Cardiometabolic biomarkers
9
Other (unclassified)
8
Renal / kidney
6
Cardiovascular outcomes
1

Top 20 metrics across this asset's endpoints

Programs for this asset

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

22 of 22

GLP-1 and incretin trials
Asset / PopulationEligibility highlightEvidence
NCT07497880Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

KAI-7535 / HRS-7535

Obesity / overweight, Type 2 diabetes

BMI ≥30Ph 2Recruiting18Jul 2027-
NCT07528027Phase III Study of HRS-7535 for Hypertension With Overweight or Obesity

KAI-7535 / HRS-7535

Hypertension, Obesity / overweight

BMI ≥24Ph 3Not yet recruiting2Dec 2027-
RENEW-CKDRenal Efficacy and Safety of the Novel Oral Small-Molecule GLP-1RA HRS-7535 Evaluated in Participants With Chronic Kidney Disease

KAI-7535 / HRS-7535

Chronic kidney disease

eGFR ≥20Ph 3Not yet recruiting2May 2031-
NCT06132204Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects

KAI-7535 / HRS-7535

Healthy volunteers, Renal impairment

Healthy volunteersPh 1Completed1Mar 2024-
NCT06820099Study on the Efficacy and Safety of HRS-7535 in Patients With Mild Decrease in Ejection Fraction/Preserved Ejection Fraction Heart Failure and Obesity

KAI-7535 / HRS-7535

Heart failure, Obesity / overweight

BMI ≥28Ph 2Recruiting1Dec 2026-
NCT07294898A Study to Investigate the Effect of a Low-fat Meal and Evening Dosing on KAI-7535 in Participants Living With Obesity or Overweight

KAI-7535 / HRS-7535

Obesity / overweight

BMI 25-40Ph 1Completed1Jan 2026-
NCT06250946Efficacy and Safety of HRS-7535 Tablets in Obese Subjects .

KAI-7535 / HRS-7535

Obesity / overweight

BMI ≤40Ph 2Completed1Jan 2025-
NCT06671821Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects

KAI-7535 / HRS-7535

Obesity / overweight

-Ph 2Completed1Aug 2025-
SOLID-DKDEfficacy and Safety of HRS-7535 Tablets in Adults With Diabetic Kidney Disease in Type 2 Diabetes

KAI-7535 / HRS-7535

Chronic kidney disease, Type 2 diabetes

BMI ≤40Ph 2Completed1Jul 2025-
NCT07269756A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects

KAI-7535 / HRS-7535

Obesity / overweight

BMI ≥26Ph 1Completed1Mar 2026-
NCT06495931Study on Drug Interaction of HRS-1780 Tablets, Henagliflozin Tablets, Metformin Tablets and HRS-7535 Tablets in Healthy Human

KAI-7535 / HRS-7535

Healthy volunteers

Male · Healthy volunteersPh 1Completed1Aug 2024-
NCT06819488A Clinical Study of Mass Balance of [14C]HRS-7535

KAI-7535 / HRS-7535

Healthy volunteers

BMI 19-26Ph 1Completed1Apr 2025-
NCT06621316A Study of Safety and Tolerability of Multiple Doses of HRS-7535 in Obese Subjects

KAI-7535 / HRS-7535

Obesity / overweight

BMI ≥30Ph 1/2Active, not recruiting1May 2025-
NCT06393348Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i.

KAI-7535 / HRS-7535

Type 2 diabetes

BMI ≤35Ph 2Completed1Nov 2024-
NCT06727838Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human

KAI-7535 / HRS-7535

Healthy volunteers

Male · Healthy volunteersPh 1Completed1Jan 2025-
NCT06961643Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function

KAI-7535 / HRS-7535

Healthy volunteers, Hepatic impairment

-Ph 1Completed1Jan 2026-
NCT06422039Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects

KAI-7535 / HRS-7535

Healthy volunteers

BMI 18-30Ph 1Completed1Aug 2024-
OUTSTAND-1A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise

KAI-7535 / HRS-7535

Type 2 diabetes

HbA1c 7-10%Ph 3Completed1Nov 2025-
NCT06589765A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin

KAI-7535 / HRS-7535

Type 2 diabetes

HbA1c 7.5-11%Ph 3Recruiting1Feb 2026-
NCT06904105A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity

KAI-7535 / HRS-7535

Obesity / overweight

BMI ≥28Ph 3Active, not recruiting1May 2026-
NCT05759897A 16 Week Study of HRS-7535 in Adults With Type 2 Diabetes Mellitus

KAI-7535 / HRS-7535

Type 2 diabetes

BMI 19-40Ph 2Unknown0Dec 2023-
NCT05347758A Phase I Single- and Multiple- Ascending Dose and Food Effect Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-7535 in Healthy Subjects

KAI-7535 / HRS-7535

Healthy volunteers

BMI 19-28Ph 1Unknown0Sep 2022-

Showing 1-22 of 22 trials