Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06216340
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-22
First Post:
2023-12-15
Brief Title:
Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes
Sponsor:
The First Peoples Hospital of Changzhou
Organization:
The First Peoples Hospital of Changzhou
Study Overview
Official Title:
Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes a Multicenter Randomized Double-blind Placebo-controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None