Status:
NOT_YET_RECRUITING
Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes
Lead Sponsor:
The First People's Hospital of Changzhou
Collaborating Sponsors:
The Second Hospital of Nanjing Medical University
The First Affiliated Hospital of Soochow University
Conditions:
Obese
Weight Loss
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 hypogl...
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: Bas...
Eligibility Criteria
Inclusion
- 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
- Ability to understand and sign the informed consent form
Exclusion
- 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;
- History of bariatric surgery;
- Untreated or uncontrolled hypothyroidism/hyperthyroidism;
- High risk of urinary tract infection;
- Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome);
- Diagnosis of congenital glucose-galactose malabsorption or familial renal glycosuria
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2.5 times the upper limit of the normal range (UNL); Total bilirubin (TBIL) ≥ 2.0 times the upper limit of the normal range;
- estimated glomerular filtration rate (eGFR)\<30 mL/min/1.73 m2 or end-stage kidney disease, or requiring dialysis;
- History of major depressive disorder or other severe psychiatric disorders, e.g. schizophrenia, bipolar disorder within the last 2 years;
- Uncontrolled treated/untreated hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
- myocardial infarction, unstable angina, revascularization surgery, or cerebrovascular diseases within the past 3 months;
- Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer) or other severe diseases, which in the investigator's opinion could interfere with the results of the trial;
- Females of child-bearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods (adequate contraceptive measures as required by local law or practice) within 24 months;
- Participation in a clinical trial within the last 3 months prior to screening;
- Previous history of gestational diabetes;
- Previous history of eating disorders;
- Current or history of treatment with medications that may cause significant weight gain, within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium);
- Diet attempts using herbal supplements or over-the-counter medications within 3 months before screening
- Any lifetime history of a suicidal attempt or a history of any suicidal behavior in the last month prior to randomization;
- Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator
- Known or suspected abuse of alcohol or narcotics
- Subjects from the same house hold participating in the trial
- Other situations which were inappropriate to the trial, at the discretion of the investigator
Key Trial Info
Start Date :
February 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06216340
Start Date
February 15 2024
End Date
October 1 2026
Last Update
January 22 2024
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