Ruiqin (henagliflozin) / Jiangsu Hengrui Pharma - LARVOL DELTA

Randomized, controlled and open label clinical trial of metformin Henagliflozin compound preparation in the treatment of type 2 diabetes mellitus patients with metabolic fatty liver disease and its effect on liver and pancreas fat content (ChiCTR) - P4 | N=60 | Recruiting | Sponsor: The First People's Hospital of Foshan; The First People's Hospital of Foshan | Not yet recruiting ➔ Recruiting

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

Clinical study on the effect of henagliflozin proline combined with metformin on serum markers of cognitive impairment related to type 2 diabetes (ChiCTR) - P2 | N=100 | Not yet recruiting | Sponsor: Affiliated Hospital of Xuzhou Medical University, Xuzhou City, Jiangsu Province; Affiliated Hospital of Xuzhou Medical University

New P2 trial • Alzheimer's Disease • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Henagliflozin for the Treatment of Patients with T2DM and CKD: A Real-World, Multicenter Case Registry Study (ChiCTR) - P4 | N=1000 | Completed | Sponsor: The 2nd Affiliated Hospital of Chongqing Medical University; The 2nd Affiliated Hospital of Chongqing Medical University

New P4 trial • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Study on the effects of SGLT2 inhibitors on proximal tubular sodium reabsorption in patients with type 2 diabetes and chronic kidney disease under different sodium dietary conditions (ChiCTR) - P=N/A | N=57 | Not yet recruiting | Sponsor: The Fourth Medical Center of Chinese PLA General Hospital; The Fourth Medical Center of Chinese PLA General Hospital

New trial • Chronic Kidney Disease • Diabetes • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

A multicenter, randomized, parallel-group clinical study on the effects of Henagliflozin Proline Tablets and Metformin Sustained-release tablets on body composition in geriatric patients with newly diagnosed type 2 diabetes mellitus (ChiCTR) - P=N/A | N=116 | Not yet recruiting | Sponsor: Huadong Hospital Affiliated to Fudan University; Huadong Hospital Affiliated to Fudan University

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

Henagliflozin enhances frontal neural activation and cognitive function versus gliclazide in type 2 diabetes patients with mild cognitive impairment: A 16-week randomized controlled trial. (PubMed, J Endocrinol Invest) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

HABIT-GEMs: Effects of Henagliflozin Proline and Metformin XR on Body Composition in Geriatric Patients With Newly Diagnosed T2DM (clinicaltrials.gov) - P4 | N=116 | Not yet recruiting | Sponsor: Bin Lu

New P4 trial • Diabetes • Geriatric Disorders • Metabolic Disorders • Type 2 Diabetes Mellitus

Effect of Henagliflozin on Myocardial Fibrosis in Non-Obstructive HCM: A Randomized, Double-Blind, Placebo-Controlled Trial Using 68Ga/18F-FAPI PET/CMR (clinicaltrials.gov) - P=N/A | N=150 | Not yet recruiting | Sponsor: Shanghai East Hospital

New trial • Cardiomyopathy • Cardiovascular • Congestive Heart Failure • Fibrosis • Hypertrophic Cardiomyopathy • Immunology • Non-obstructive Hypertrophic Cardiomyopathy

Health: Henagliflozin Reducing Infarct Size After Priamry PCI in Patients With ST Segment Elevation Myocardial Infarction (clinicaltrials.gov) - P4 | N=248 | Completed | Sponsor: Qian geng | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Oct 2025 | Trial primary completion date: Oct 2024 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction

Efficacy and Safety of HRS-1780 Tablets and Henagliflozin Proline Tablets in Patients With Chronic Kidney Disease (clinicaltrials.gov) - P2 | N=181 | Completed | Sponsor: Shandong Suncadia Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Chronic Kidney Disease • Nephrology • Renal Disease

A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Fecal Microbiota Capsule Transplantation Combined with Henagliflozin in Patients with Type 2 Diabetic Kidney Disease (ChiCTR) - P=N/A | N=100 | Not yet recruiting | Sponsor: Affiliated Hospital of Southwest Medical University; Affiliated Hospital of Southwest Medical University

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

Effects of Henagliflozin on Cardiac Structure in Patients with Heart Failure with Preserved Ejection Fraction Undergoing Dialysis: The HELD-HF Randomized Controlled Trial (KIDNEY WEEK 2025) - P=N/A | "The incidence of adverse events was similar between the two groups (35.7% in the henagliflozin group and 32.1% in the placebo group). Conclusion Henagliflozin significantly reduced LVMI compared with placebo in patients with HFpEF on dialysis and was safe over 24 weeks of treatment."

Clinical • Cardiovascular • Congestive Heart Failure • Heart Failure

Randomized, controlled and open label clinical trial of metformin Henagliflozin compound preparation in the treatment of type 2 diabetes mellitus patients with metabolic fatty liver disease and its effect on liver and pancreas fat content (ChiCTR) - P4 | N=60 | Not yet recruiting | Sponsor: The First People's Hospital of Foshan; The First People's Hospital of Foshan

New P4 trial • Diabetes • Hepatology • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy of Henagliflozin in Patients with Type 2 Diabetes Mellitus and Overweight or Obesity (ChiCTR) - P4 | N=5000 | Not yet recruiting | Sponsor: Beijing Chaoyang Hospital, Capital Medical University; Beijing Chaoyang Hospital, Capital Medical University

New P4 trial • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Randomized Crossover Trial on the Effect of Henagliflozin on Heart Stress in Patients with Stage B Heart Failure (ChiCTR) - P3 | N=38 | Not yet recruiting | Sponsor: Guangdong Provincial Yingde People's Hospital; Guangdong Provincial Yingde People's Hospital

New P3 trial • Cardiovascular • Congestive Heart Failure • Heart Failure

Henagliflozin Increases Serum and Salivary Levels of High-Molecular-Weight Adiponectin in Patients with Type 2 Diabetes in the Community. (PubMed, Int J Gen Med) - "In order to reveal the influence factors of adiponectin in serum and saliva, linear stepwise regression analysis showed that waist circumference was an independent risk factor for adiponectin in serum (95% CI: -0.087, -0.015; P < 0.05), and gender was an independent risk factor for adiponectin in saliva (95% CI: -4.663, -0.529; P < 0.05). In our study, serum and salivary HMW adiponectin levels were decreased in patients with T2DM, and Sodium-glucose co-transporter-2 (SGLT2) inhibitors could improve serum and salivary HMW adiponectin levels after treatment, which is expected to be a major target for diabetes treatment."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy and Safety of Henagliflozin Proline and Metformin Hydrochloride Extended-release Tablets (Ⅰ) Versus Metformin Tablets in Patients With New-onset Type 2 Diabetes: a Multicenter, Randomized Controlled Study (clinicaltrials.gov) - P4 | N=268 | Recruiting | Sponsor: Zhejiang Provincial People's Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jun 2026 ➔ Dec 2026 | Trial primary completion date: Dec 2025 ➔ Jun 2026

Enrollment open • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • 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

Effect of henagliflozin on aging biomarkers in patients with type 2 diabetes: A multicenter, randomized, double-blind, placebo-controlled study. (PubMed, Cell Rep Med) - P4 | "These findings suggest that henagliflozin may exert anti-aging effects through multiple pathways. This study is registered at Chinese Clinical Trial Registry (ChiCTR2300068127)."

Biomarker • Clinical • Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus • GZMB • IGFBP3 • PRF1

Effects of Henagliflozin on the Brain Function in T2DM Patients With Mild Cognitive Impairment: a Randomized, Parallel Controlled Clinical Trial (clinicaltrials.gov) - P=N/A | N=24 | Completed | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting ➔ Completed | N=60 ➔ 24 | Trial completion date: Jun 2026 ➔ Jun 2025

Enrollment change • Trial completion • Trial completion date • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

HOLIDYA: The Effects of Henagliflozin on Glucose Fluctuation and Immunosenescence in Type 2 Diabetes Patients on Insulin Therapy (clinicaltrials.gov) - P4 | N=64 | Recruiting | Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2025 ➔ Jul 2025

Enrollment open • Trial initiation date • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Physiologically-Based Pharmacokinetics and Empirical Pharmacodynamic Modeling for Pediatric Henagliflozin Dosing: Clinical Insights for Chinese Patients. (PubMed, Pediatr Diabetes) - "The verified PBPK and empirical PD models informed dosing recommendations in pediatric populations aged 1 month to 18 years, achieving henagliflozin exposures comparable to those in adult patients receiving a 5-10 mg dose. This study shows that PBPK and PD modeling effectively guide pediatric dosing of henagliflozin, reducing trial reliance and supporting real-world validation."

Journal • PK/PD data • Hepatology • Pediatrics

Cancelled by the investigator Effect of Henagliflozin on cardiac function and structure in HFpEF patients with combined type 2 diabetes mellitus (ChiCTR) - P4 | N=40 | Suspended | Sponsor: Department of Cardiovascular Medicine, Hubei Third People's Hospital; Hubei NO. 3 People’s Hospital | Not yet recruiting ➔ Suspended

Trial suspension • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

In vivo assessment of pharmacokinetic interactions of empagliflozin and henagliflozin with sorafenib: an animal-based study. (PubMed, PeerJ) - "Empagliflozin and henagliflozin inhibited Oatp1b2 expression in the liver and P-gp expression in the liver and intestines. These pharmacokinetic interactions provide valuable insights for future studies on optimizing the dosing regimens of sorafenib in combination with empagliflozin or henagliflozin, potentially reducing toxicity risks and improving the safety of coadministration in clinical settings."

Journal • PK/PD data • Preclinical • Diabetes • Endocrine Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Metabolic Disorders • Oncology • Renal Cell Carcinoma • Solid Tumor • Thyroid Gland Carcinoma • Type 2 Diabetes Mellitus

An Observational Study on the Safety and Efficacy of Henagliflozin in Chinese Patients With Type 2 Diabetes (clinicaltrials.gov) - P=N/A | N=10000 | Recruiting | Sponsor: Second Affiliated Hospital of Guangxi Medical University | Not yet recruiting ➔ Recruiting

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