Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06216340
Study type	Interventional
Source	The First People's Hospital of Changzhou
Contact	Fei Hua, PHD
Phone	+86-0519-68876242
Email	huafei1970@suda.edu.cn
Status	Not yet recruiting
Phase	Phase 4
Start date	February 15, 2024
Completion date	October 1, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.