A Phase 4 interventional study of Henagliflozin and Placebo in Obese, Weight Loss and Pre-diabetes, sponsored by The First People's Hospital of Changzhou. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-01-22.
Sponsored by The First People's Hospital of Changzhou · Phase 4, Interventional, and Treatment
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.
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 300 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →The First People's Hospital of Changzhou is the lead sponsor of 28 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo and diet-exercise therapy
Drug: Placebo
10mg of Henagliflozin and diet-exercise therapy
Drug: Henagliflozin
10mg of Henagliflozin and diet-exercise therapy
Also known as: diet-exercise therapy
Placebo and diet-exercise therapy
Also known as: diet-exercise therapy
Weight change
Proportion of weight change from baseline
Time frame: 3 months (12 weeks)
Proportion of ≥5% weight loss
Proportion of patients who lost at least 5% of their body weight from baseline
Time frame: 3 months (12 weeks)
Incident diabetes
New-onset diabetes during follow up
Time frame: 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks)
Absolute weight change
Absolute value of weight change from baseline for each group at the 3rd month
Time frame: 3 months (12 weeks)
BMI change
Change in BMI from baseline for each group at the 3rd month. BMI was defined as weight (kg) divided by height squared (m2), weight and height will be combined to report BMI in kg/m\^2.
Time frame: 3 months (12 weeks)
Change of waist circumference
Change of waist circumference at the 3rd month
Time frame: 3 months (12 weeks)
Change of waist-to-hip ratio
Change of waist-to-hip ratio at the 3rd month. Waist-to-hip ratio will be defined as waist circumference (cm) to hip circumference (cm).
Time frame: 3 months (12 weeks)
Change of FPG
Change of FPG from baseline
Time frame: 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks)
Change of PPG
Change of PPG from baseline
Time frame: 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks)
Changes of insulin levels
Changes of fasting and oral glucose tolerance test-2h insulin level from baseline
Time frame: 3 months (12 weeks), 6 months (24 weeks), 12 months (48 weeks)
Changes of C-peptide levels
Changes of fasting and oral glucose tolerance test-2h C-peptide levels from baseline
Time frame: 3 months (12 weeks), 6 months (24 weeks), 12 months (48 weeks)
Changes of HbA1c
Changes of HbA1c levels from baseline
Time frame: 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks)
Changes of triglyceride
Changes in triglyceride from baseline
Time frame: 6 months (24 weeks), 12 months (48 weeks)
Changes of total cholesterol
Changes in total cholesterol from baseline
Time frame: 6 months (24 weeks), 12 months (48 weeks)
Changes of LDL-c
Changes in LDL-c from baseline
Time frame: 6 months (24 weeks), 12 months (48 weeks)
Changes of HDL-c
Changes in HDL-c from baseline
Time frame: 6 months (24 weeks), 12 months (48 weeks)
Change of urinary albumin-to-creatinine ratio
Change of urinary albumin-to-creatinine ratio from baseline in each group
Time frame: 6 months (24 weeks), 12 months (48 weeks)
Changes of C-reactive protein
Changes of C-reactive protein in each group relative to baseline
Time frame: 6 months (24 weeks), 12 months (48 weeks)
No study locations are listed for this record.
Plan to share: No — The data in the current study arisen from a dataset of Department of Endocrine and Metabolic Diseases, the First People's Hospital of Changzhou, Third Affiliated Hospital of Soochow University, are not publicly available due to security consideration, but are available from the corresponding author on reasonable request.
Start is estimated for Feb 2024; primary completion for Oct 2026, 31 months later.
Of 190 non-industry phase 4 interventional studies under Obesity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 52. This study's planned 31 months is close to that.
Counting every sponsor, half of 210 studies reached it within 31 months; a quarter within 15 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Henagliflozin
The First People's Hospital of Changzhou