Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes

This trial is conducted in China. The purpose of the 24-week trial is to investigate the efficacy of henagliflozin to induce body weight loss and the purpose of the extension is to evaluate the hypoglycemic effect of henagliflozin in obese subjects without diabetes. Trial has the following two periods: 1) A 12-week randomized, double-blind, placebo-controlled, multi-center trial for evaluating the efficacy of henagliflozin to induce body weight loss; 2) A 12-week multicenter randomized controlled open-label trial for evaluating the hypoglycemic effect of henagliflozin followed by a 24-week extension period.

NCT Number	NCT06216340
Lead Sponsor	The First People's Hospital of Changzhou Collaborators: The Second Hospital of Nanjing Medical University, The First Affiliated Hospital of Soochow University, Second Affiliated Hospital of Soochow University, Wuxi People's Hospital, Northern Jiangsu People's Hospital, The Affiliated Hospital of Xuzhou Medical University, The First People's Hospital of Lianyungang, Affiliated Hospital of Jiangsu University, The fourth affiliated hospital of nantong university
Conditions	Obese, Weight Loss, Pre-diabetes
Enrollment	300 participants
Start Date	2024-02-15
Primary Completion	2026-10-01 (estimated)
Study Completion	2026-10-01 (estimated)
Updated on ClinicalTrials.gov	2024-01-22