Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes

Launched by THE FIRST PEOPLE'S HOSPITAL OF CHANGZHOU · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a medication called henagliflozin to see if it can help people who are obese lose weight, even if they don’t have diabetes. The study will last for 24 weeks and will take place in China. It is divided into two main parts: the first part will last 12 weeks and will include a comparison between those taking henagliflozin and a placebo (a pill with no active medicine) to see how effective it is for weight loss. The second part will also last 12 weeks and will focus on how henagliflozin affects blood sugar levels in participants who are not diabetic.

To participate in this trial, you need to be between 18 and 65 years old and have a body mass index (BMI) of 28 or higher, which indicates obesity. You should not have diabetes or be taking certain medications for weight loss. Participants can expect to receive either the study drug or a placebo during the first part, and they will be monitored regularly. The trial is not currently recruiting participants, but it’s important to know that those with certain health conditions, such as severe kidney issues or recent history of major health problems, may not be eligible to join.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 18 years old≤age≤65 years old, regardless of gender and race
• • 2. Nondiabetic population: without hypoglycemic treatment, FPG\<7.0 mmol/l, PPG\<11.1 mmol/l, and HbA1c\<6.5%
• • 3. obesity: BMI≥28 kg/m2
• • 4. Stable weight: weight change less than 5kg in the past 3 months
• • 5. Ability to understand and sign the informed consent form
• Exclusion Criteria:
• • 1. Allergies to Henagliflozin or its formulations;
• • 2. Participants have been definitely diagnosed with diabetes;
• • 3. HbA1c≥6.5 % or FPG≥7.0 mmol/l, or PPG≥11.1 mmol/l;
• • 4. 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;
• • 5. History of bariatric surgery;
• • 6. Untreated or uncontrolled hypothyroidism/hyperthyroidism;
• • 7. High risk of urinary tract infection;
• • 8. Obesity induced by other endocrinologic disorders (e.g. Cushing's Syndrome);
• • 9. Diagnosis of congenital glucose-galactose malabsorption or familial renal glycosuria
• • 10. 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;
• • 11. estimated glomerular filtration rate (eGFR)\<30 mL/min/1.73 m2 or end-stage kidney disease, or requiring dialysis;
• • 12. History of major depressive disorder or other severe psychiatric disorders, e.g. schizophrenia, bipolar disorder within the last 2 years;
• • 13. Uncontrolled treated/untreated hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg)
• • 14. myocardial infarction, unstable angina, revascularization surgery, or cerebrovascular diseases within the past 3 months;
• • 15. 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;
• • 16. 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;
• • 17. Participation in a clinical trial within the last 3 months prior to screening;
• • 18. Previous history of gestational diabetes;
• • 19. Previous history of eating disorders;
• • 20. 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);
• • 21. Diet attempts using herbal supplements or over-the-counter medications within 3 months before screening
• • 22. Any lifetime history of a suicidal attempt or a history of any suicidal behavior in the last month prior to randomization;
• • 23. Surgery scheduled for the trial duration period, except for minor surgical procedures, at the discretion of the investigator
• • 24. Known or suspected abuse of alcohol or narcotics
• • 25. Subjects from the same house hold participating in the trial
• • 26. Other situations which were inappropriate to the trial, at the discretion of the investigator