HRS-7535 / Jiangsu Hengrui Pharma, Kailera Therapeutics - LARVOL DELTA

A Clinical Study of Mass Balance of [14C]HRS-7535 (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of HRS-7535 in for Heart Failure With Preserved Ejection Fraction and Obesity (clinicaltrials.gov) - P2 | N=180 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Cardiovascular • Congestive Heart Failure • Genetic Disorders • Heart Failure • Obesity

A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise (clinicaltrials.gov) - P3 | N=284 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Genetic Disorders • Obesity

HRS-7535-202: Efficacy and Safety of HRS-7535 Tablets in Obese Subjects . (clinicaltrials.gov) - P2 | N=235 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Genetic Disorders • Obesity

Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects (clinicaltrials.gov) - P2 | N=81 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | N=180 ➔ 81 | Not yet recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Obesity

A Study of Safety and Tolerability of Multiple Doses of HRS-7535 in Obese Subjects (clinicaltrials.gov) - P1/2 | N=74 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Efficacy and Safety of a Novel Oral Small Molecule Glucagon-Like Peptide 1 Receptor Agonist (HRS-7535) in Type 2 Diabetes Mellitus Patients Inadequately Controlled by Metformin (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Hengrui initiates Phase III clinical trial of oral GLP-1 receptor agonist for weight loss [Google translation] (163.com) - "On March 31, the Drug Clinical Trial Registration and Information Disclosure Platform showed that Hengrui Medicine launched a Phase III clinical study of the GLP-1 receptor agonist HRS-7535 tablets for weight loss indications. The study aims to evaluate the effectiveness and safety of HRS-7535 tablets in overweight or obese subjects."

Trial status • Obesity

A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity (clinicaltrials.gov) - P3 | N=550 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Genetic Disorders • Obesity

Efficacy and Safety of HRS-7535 in for Heart Failure With Preserved Ejection Fraction and Obesity (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Cardiovascular • Congestive Heart Failure • Genetic Disorders • Heart Failure • Obesity

A Clinical Study of Mass Balance of [14C]HRS-7535 (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

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

OUTSTAND-2: A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin (clinicaltrials.gov) - P3 | N=800 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Study on Drug Interaction of Metformin Tablets and HRS-7535 Tablets in Healthy Human (clinicaltrials.gov) - P1 | N=54 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

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

A Study of HRS-7535 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Diet and Exercise (clinicaltrials.gov) - P3 | N=272 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Long-term Efficacy and Safety of HRS-7535 Tablets in Obese Subjects (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Obesity

Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A Study of Safety and Tolerability of Multiple Doses of HRS-7535 in Obese Subjects (clinicaltrials.gov) - P1/2 | N=72 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1/2 trial • Genetic Disorders • Obesity

A Study of HRS-7535 Compared With Dapagliflozin in Adult Participants With Type 2 Diabetes and Inadequately Controlled With Metformin (clinicaltrials.gov) - P3 | N=800 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P3 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

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-7535 Tablets in Adults With Type 2 Diabetic Kidney Disease (clinicaltrials.gov) - P2 | N=186 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Bioavailability and Food Effects of HRS-7535 Tablets With Different Formulating Processes in Healthy Subjects (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

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

Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i. (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of HRS-7535 Tablets in Obese Subjects . (clinicaltrials.gov) - P2 | N=225 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P2 trial • Genetic Disorders • Obesity

Pharmacokinetic and Safety Studies of HRS-7535 in Subjects With Moderate Renal Insufficiency and Healthy Subjects (clinicaltrials.gov) - P1 | N=16 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

Trial completion date • Trial initiation date • Trial primary completion date • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus