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

A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects (clinicaltrials.gov) - P1 | N=40 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Genetic Disorders • Obesity

HRS-7535-205: Efficacy and Safety of HRS-7535 Tablets in T2DM Subjects Poorly Controlled With Metformin and SGLT2i. (clinicaltrials.gov) - P2 | N=155 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Mar 2025

Trial completion • Trial completion date • 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=281 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Completed | N=186 ➔ 281

Enrollment change • Trial completion • Diabetes • Diabetic Nephropathy • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

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

Trial completion • Obesity

Efficacy and Safety of the Oral Small-Molecule GLP-1 Receptor Agonist HRS-7535 in Patients with Diabetic Kidney Disease (KIDNEY WEEK 2025) - P2 | "In patients receiving standard of care (SOC), including renin–angiotensin system inhibitors (RASi), sodium-glucose cotransporter-2 inhibitors (SGLT2i), and finerenone, the potential additive renal protection of GLP-1RAs requires further evaluation. Conclusion In patients with DKD and persistent macroalbuminuria despite SOC, the oral small-molecule GLP-1RA HRS-7535 significantly reduced albuminuria and improved multiple metabolic parameters, with a safety profile consistent with GLP-1RAs. HRS-7535 may provide a new therapeutic option for patients with DKD."

Clinical • Late-breaking abstract • Chronic Kidney Disease • Diabetic Nephropathy • Nephrology • Renal Disease

Kailera Therapeutics Announces $600 Million Series B Financing to Further Advance Pipeline of Next-Generation Therapies for the Treatment of Obesity (GlobeNewswire) - "The financing will be fully funded at closing and will support the advancement of Kailera’s leading obesity portfolio, including a global Phase 3 clinical program of Kailera’s lead candidate KAI-9531, an injectable dual GLP-1/GIP receptor agonist with potentially best-in-category weight loss...The Phase 3 program will include two trials in adults living with obesity or overweight with comorbidities, with and without type 2 diabetes, and an additional trial in adults living with a BMI of 35 or higher...'We look forward to starting our global Phase 3 trials of KAI-9531 by the end of this year'....The financing will also advance KAI-7535..."

Financing • New P3 trial • Obesity • Type 2 Diabetes Mellitus

Efficacy and safety of a novel oral small molecule GLP-1RA (HRS-7535) in Chinese patients with type 2 diabetes inadequately controlled by metformin and SGLT2 inhibitor (EASD 2025) - P2 | "During the lead in period, HRS-7535 placebo tablet and henagliflozin metformin extended-release tablets were administrated to pts. HRS-7535 achieved significant HbA1c reduction in Chinese pts with T2DM inadequately controlled on metformin and an SGLT2 inhibitor, and exhibited a safety profile consistent with other GLP-1RAs. These data support further clinical development of HRS-7535 for T2DM treatment."

Clinical • Late-breaking abstract • Diabetes • Hypoglycemia • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy and safety of HRS-7535 in patients with T2DM poorly controlled by metformin [Google translation] (Sohu.com) - P2 | N=150 | NCT06393348 | Sponsor: Shandong Suncadia Medicine Co., Ltd. | "177 patients completed the 16-week treatment cycle....At 16 weeks, the HbA 1c reductions in each dose group of HRS-7535 were -1.19% (15 mg), -1.59% (30 mg), -1.82% (60 mg), -1.64% (90 mg) and -0.25% (placebo group), respectively, and the reductions in each group were significantly better than those in the placebo group...In addition, dose-dependent decreases in fasting blood glucose (FPG), 2-hour postprandial blood glucose (2-h PPG) and waist circumference were observed in all dose groups of HRS-7535, suggesting its comprehensive improvement effect on metabolic function. It is worth noting that only 3.2% of the patients in the HRS-7535 group underwent rescue treatment, which is much lower than the 30.8% in the placebo group, further confirming that it can effectively control blood sugar."

P2 data • Type 2 Diabetes Mellitus

Weight loss efficacy of HRS-7535 in non-diabetic obese people: a phase II randomized controlled study [Google translation] (Sohu.com) - P2 | N=235 | NCT06250946 | Sponsor: Shandong Suncadia Medicine Co., Ltd. | "At week 26, the least squares means of the percentage change in body weight from baseline in the HRS-7535 30 mg group, 60 mg group, 120 mg group, and 180 mg group were –2.99%, –7.09%, –6.17%, and –9.36%, respectively, and the placebo group was -2.50%. The 180 mg group had the most significant weight loss relative to the placebo group ( P < 0.0001) (Figure 5). At the same time, 41.7% of patients in the 180 mg group had a weight loss of ≥10%, while only 6.5% in the placebo group...indicating the robustness of the weight loss effect of the 180 mg group in obese patients. It is worth noting that the weight loss effect of the 180 mg group was maintained during the 10-week extension period. At 36 weeks, the average weight loss reached 9.47%, showing the potential of HRS-7535 180 mg for long-term weight management."

P2 data • Obesity

Efficacy and Safety of a Novel Oral Small Molecule GLP-1RA in Chinese Obese Adults without Diabetes (ADA 2025) - "In obese adults without diabetes, HRS-7535 at doses of 60, 120, or 180 mg QD resulted in clinically meaningful and statistically significant reductions in BW at wk 26 compared with PBO. HRS-7535 exhibited a safety profile consistent with other GLP-1 RAs."

Clinical • Diabetes • Metabolic 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) - "HRS-7535 significantly resulted HbA1c in Chinese pts with T2DM inadequately controlled on metformin and exhibited an acceptable safety profile consistent with other GLP-1RAs."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Obesity • Pancreatitis • Type 2 Diabetes Mellitus

A Trial of HRS-7535 Tablets in Subjects With Overweight or Obesity (clinicaltrials.gov) - P3 | N=556 | Active, not recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Jiangsu Hengrui Pharmaceuticals and Kailera Therapeutics Announce Clinical Data Presentations at the American Diabetes Association 85th Scientific Sessions (The Manila Times) - "Jiangsu Hengrui Pharmaceuticals Co., Ltd...and Kailera Therapeutics, Inc...announced the presentation of six abstracts at the 85th Scientific Sessions of the American Diabetes Association (ADA), taking place June 20-23, 2025, in Chicago, IL. The presentations will highlight the breadth of the companies' metabolic disease portfolio, including data from several clinical-stage injectable and oral therapies. Data presented will cover results from clinical trials sponsored and conducted by Hengrui for an injectable GLP-1/GIP receptor dual agonist HRS9531 (in development as KAI-9531 outside of Greater China), an oral small molecule GLP-1 receptor agonist HRS-7535 (KAI-7535), and an oral formulation of HRS9531 (KAI-9531)."

Clinical data • Obesity • Type 2 Diabetes Mellitus

Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Hepatology • Metabolic Disorders

Investigation of Pharmacokinetics and Safety of HRS-7535 in Subjects With Hepatic Impairment and Normal Hepatic Function (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Shandong Suncadia Medicine Co., Ltd.

New P1 trial • Diabetes • Hepatology • Metabolic Disorders

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

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