Weight Loss Clinical Trial
Official title:
Efficacy of Henagliflozin for Weight Loss in Obesity Without Diabetes: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical 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.
Status | Not yet recruiting |
Enrollment | 300 |
Est. completion date | October 1, 2026 |
Est. primary completion date | October 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The First People's Hospital of Changzhou | Affiliated Hospital of Jiangsu University, Northern Jiangsu People's Hospital, Second Affiliated Hospital of Soochow University, The Affiliated Hospital of Xuzhou Medical University, The First Affiliated Hospital of Soochow University, The First People's Hospital of Lianyungang, The fourth affiliated hospital of nantong university, The Second Hospital of Nanjing Medical University, Wuxi People's Hospital |
American Diabetes Association Professional Practice Committee. 2. Classification and Diagnosis of Diabetes: Standards of Medical Care in Diabetes-2022. Diabetes Care. 2022 Jan 1;45(Suppl 1):S17-S38. doi: 10.2337/dc22-S002. — View Citation
Garvey WT, Mechanick JI, Brett EM, Garber AJ, Hurley DL, Jastreboff AM, Nadolsky K, Pessah-Pollack R, Plodkowski R; Reviewers of the AACE/ACE Obesity Clinical Practice Guidelines. AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY COMPREHENSIVE CLINICAL PRACTICE GUIDELINES FOR MEDICAL CARE OF PATIENTS WITH OBESITYEXECUTIVE SUMMARYComplete Guidelines available at https://www.aace.com/publications/guidelines. Endocr Pract. 2016 Jul;22(7):842-84. doi: 10.4158/EP161356.ESGL. — View Citation
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Wang Y, Zhao L, Gao L, Pan A, Xue H. Health policy and public health implications of obesity in China. Lancet Diabetes Endocrinol. 2021 Jul;9(7):446-461. doi: 10.1016/S2213-8587(21)00118-2. Epub 2021 Jun 4. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Absolute weight change | Absolute value of weight change from baseline for each group at the 3rd month | 3 months (12 weeks) | |
Other | 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. | 3 months (12 weeks) | |
Other | Change of waist circumference | Change of waist circumference at the 3rd month | 3 months (12 weeks) | |
Other | 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). | 3 months (12 weeks) | |
Other | Change of FPG | Change of FPG from baseline | 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks) | |
Other | Change of PPG | Change of PPG from baseline | 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks) | |
Other | Changes of insulin levels | Changes of fasting and oral glucose tolerance test-2h insulin level from baseline | 3 months (12 weeks), 6 months (24 weeks), 12 months (48 weeks) | |
Other | Changes of C-peptide levels | Changes of fasting and oral glucose tolerance test-2h C-peptide levels from baseline | 3 months (12 weeks), 6 months (24 weeks), 12 months (48 weeks) | |
Other | Changes of HbA1c | Changes of HbA1c levels from baseline | 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks) | |
Other | Changes of triglyceride | Changes in triglyceride from baseline | 6 months (24 weeks), 12 months (48 weeks) | |
Other | Changes of total cholesterol | Changes in total cholesterol from baseline | 6 months (24 weeks), 12 months (48 weeks) | |
Other | Changes of LDL-c | Changes in LDL-c from baseline | 6 months (24 weeks), 12 months (48 weeks) | |
Other | Changes of HDL-c | Changes in HDL-c from baseline | 6 months (24 weeks), 12 months (48 weeks) | |
Other | Change of urinary albumin-to-creatinine ratio | Change of urinary albumin-to-creatinine ratio from baseline in each group | 6 months (24 weeks), 12 months (48 weeks) | |
Other | Changes of C-reactive protein | Changes of C-reactive protein in each group relative to baseline | 6 months (24 weeks), 12 months (48 weeks) | |
Primary | Weight change | Proportion of weight change from baseline | 3 months (12 weeks) | |
Secondary | Proportion of =5% weight loss | Proportion of patients who lost at least 5% of their body weight from baseline | 3 months (12 weeks) | |
Secondary | Incident diabetes | New-onset diabetes during follow up | 1 month (4 weeks), 2 months (8 weeks), 3 months (12 weeks), 6 months (24 weeks), 9 months (36 weeks), 12 months (48 weeks) |
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