NCT06216340

Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes

Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: The First People's Hospital of Changzhou · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Primary Hypothesis: The 12-week henagliflozin taking could induce significantly higher weight loss in obese subjects without diabetes, compared to diet-exercise therapy. Assessment time points: Baseline: prior to taking henagliflozin or diet-exercise therapy V1: 4 weeks following the henagliflozin taking or diet-exercise therapy V2: 4 weeks following V1 V3: 4 weeks following V2 Specific Aims 1: To examine and compare the weight loss, assessed by weight, waist circumference, hip circumference and BMI, after 12-week henagliflozin taking or diet-exercise therapy in obese without diabetes. Specific Aims 2: To examine and compare the change of glucose level after 12-week henagliflozin taking or diet-exercise therapy in obese without diabetes. Secondary Hypothesis 1: The 24-week henagliflozin taking could siginificantly improve the glucose control in obese subjects with pre-diabetes, compared to diet-exercise therapy. Assessment time points: Baseline: prior to taking henagliflozin or diet-exercise therapy V4: 12 weeks following V3 Specific Aims: To examine and compare the change of glucose level, assessed by fasting plasma glucose (FPG), postprandial plasma glucose (PPG), HbA1c, insulin levels, after 24-week henagliflozin taking or diet-exercise therapy.

Conditions

• Obese
• Weight Loss
• Pre-diabetes

Interventions

Type	Name	Description
DRUG	Henagliflozin	10mg of Henagliflozin and diet-exercise therapy
DRUG	Placebo	Placebo and diet-exercise therapy

Timeline

• Start date: 2024-02-15
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-01-22
• Last updated: 2024-01-22