Health Condition 1: R730- Abnormal glucose
Conditions
Interventions
Intervention1: Feiolix Capsule 287.5 mg (4 Feiolix capsules = 1150 mg)
: Four capsules to be taken with water, once a day, orally 5 minutes before breakfast for 90 days
Intervention2: Feiolix Capsule
Sponsors
Viridis BioPharma Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult male and female participants, 20 to 65 years of age (both inclusive). 2. Participants with BMI greater than or equal to 25.00 and less than or equal to 29.9 kg/m2 at screening (overweight). 3. Participants with Glycosylated Hemoglobin (HbA1c) greater than or equal to 5.7 % and less than or equal to 6.4%. 4. Participants whose IDRS (Indian Diabetics Risk score) is less than or equal to 60. 5. Participants who are willing to give informed consent for participation in the study and willing to adhere to all protocol procedures.
Exclusion criteria
Exclusion criteria: 1. Participants with a known history of hypersensitivity to the study medication or any of the ingredients of the formulation. 2. Participants with type 1 or type 2 Diabetes mellitus (T2DM), gestational diabetes or secondary diabetes. 3. Participants on treatment with a glucose-lowering or weight loss agent (s) within 90 days before screening. 4. Participants with hypothyroidism or hyperthyroidism. 5. Participants with elevated liver enzymes AST and/or ALT more than 3 times the upper normal limit. 6. Participants with abnormal renal function as measured by eGFR less than 60 ml/min/1.73m2. 7. Participants who had bariatric surgery. 8. Participants with a significant change in usual diet and/or weight loss of more than 4.5 kg in the last 2 months. 9. Participants with a known history of chronic smoking, alcohol or drug abuse within the 12 months prior to screening. 10. Participants with a known history or ongoing malignancy. 11. Participants with the treatment of immunosuppressive medications in past three months. 12. Participants with any other co-morbidities necessitating medical care. 13. Participants who have undergone surgery in the last 6 months including but not limited to angioplasty, abdominal surgeries (including weight loss surgery) or partial/complete resection of stomach or bowel. 14. Participants with the presence or history of psychiatric illnesses, including eating disorders. 15. Participants with a family history of obesity. 16. Participants using phytoherbal supplements, dietary, nutraceuticals, allopathic, or ayurvedic supplements for weight loss or blood glucose management, supplements known to affect hunger/satiety/appetite/gut microbiome. 17. Any other health or mental condition or any significant laboratory parameters that in the investigators opinion may adversely affect the participants ability to complete the study or its measures or that may pose significant risk to the participant. 18. Female participants who are pregnant or lactating or planning to become pregnant during the study period. Females or males who are not ready to use acceptable contraceptive methods during the course of study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in Glycosylated hemoglobin (HbA1c) from baseline to Visit 5/Day 90±3. Mean change in appetite regulatory hormone [Glucagon-like peptide 1(GLP-1)] in fasting and post standardized breakfast â?? 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3.Timepoint: 90 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in blood sugar levels in fasting and post standardized breakfast â?? 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3.Timepoint: 90 Days;Mean change in appetite regulatory hormone (Glucagon and Ghrelin) in fasting and post standardized breakfast â?? 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3.Timepoint: 90 Days;Mean change in insulin resistance (Insulin) in fasting and post standardized breakfast â?? 30 minutes, 1 hour and 2 hours from Visit 2/Day 1 to Visit 5/Day 90±3.Timepoint: 90 Days;Mean change in insulin resistance (HOMA IR score) in fasting from Visit 2/Day 1 to Visit 5/Day 90±3.Timepoint: 90 Days;Mean change in fat metabolism (Lipid Profile) in fasting from Visit 2/Day 1 to Visit 5/Day 90±3.Timepoint: 90 Days;Mean change in anthropometric parameters (Body Weight, BMI and Waist Circumference) from baseline to Visit 3/Day 30±3, Visit 4/Day 60±3 and Visit 5/Day 90±3.Timepoint: 90 Days;Mean change in satiety (Visual Analog Scale for Satiety Assessment) post standardized breakfast â?? 30 minutes, 1 hour, 2 hours and 3 hours from Visit 2/Day 1 to Visit 5/Day 90±3.Timepoint: 90 Days;Safety Endpoint: The assessment of safety of Investigational Product will be based on incidence of AEs, SAEs and changes in laboratory parameters. Timepoint: 90 Days | — |
Countries
India
Contacts
Public ContactDr Neeta Nargundkar
Biosphere Clinical Research Pvt Ltd
Outcome results
None listed