Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe First People's Hospital of Changzhou
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years old≤age≤65 years old, regardless of gender and race
Nondiabetic population: without hypoglycemic treatment, FPG<7.0 mmol/l, PPG<11.1 mmol/l, and HbA1c<6.5%
obesity: BMI≥28 kg/m2
Stable weight: weight change less than 5kg in the past 3 months
Disqualifiers
Allergies to Henagliflozin or its formulations;
Participants have been definitely diagnosed with diabetes;
HbA1c≥6.5 % or FPG≥7.0 mmol/l, or PPG≥11.1 mmol/l;
Participants have used glucagon-like peptide-1 (GLP-1) receptor agonists, sodium glucose linked transporter-2 (SGLT-2) inhibitors, or other weight loss related drugs within the past 3 months;
Trial design
Design model
Parallel
Treatments tested in this trial
Henagliflozin
Drug10mg of Henagliflozin and diet-exercise therapy
Placebo
DrugPlacebo and diet-exercise therapy
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: Control groupPlacebo comparator 1 intervention
Group B: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Weight change
Proportion of weight change from baseline
Time frame
3 months (12 weeks)Secondary outcomes
1
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)2
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)Other outcomes
1
Absolute weight change
Absolute value of weight change from baseline for each group at the 3rd month
Time frame
3 months (12 weeks)2
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)3
Change of waist circumference
Change of waist circumference at the 3rd month
Time frame
3 months (12 weeks)4
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)Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
The First People's Hospital of Changzhou
Lead sponsor
The Second Hospital of Nanjing Medical University
Collaborator
The First Affiliated Hospital of Soochow University
Collaborator
Second Affiliated Hospital of Soochow University
Collaborator
Wuxi People's Hospital
Collaborator
Northern Jiangsu People's Hospital
Collaborator
The Affiliated Hospital of Xuzhou Medical University
Collaborator
The First People's Hospital of Lianyungang
Collaborator
Affiliated Hospital of Jiangsu University
Collaborator
The fourth affiliated hospital of nantong university
Collaborator
Source ClinicalTrials.gov
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