Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: CG-DL (Korglutide): Patients instructed to mix the contents of one sachet with approximate 100mL water and consumed at any time of day, with or without meals.
If a dose is missed, trea
Sponsors
Biosite Research private Limited
Caregen Co Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults male and female subjects aged 18 to 65 years at the time of screening 2.Body Mass Index BMI Non-diabetic cohort BMI more than equal to 30 kg per meter square Diabetic cohort Type 2 Diabetes BMI more than equal to 27 kg per meter square 3.Type 2 Diabetes Mellitus Diabetic Cohort Diagnosed at least 6 months prior to screening Glycated hemoglobin HbA1c between 7.0 percent and 10.0 Percent at screening. On a stable regimen of oral antidiabetic drugs OADs or insulin for at least 3 months before randomization. 4. Demonstrates a stable body weight Pulse or Minus 5 kg for at least 3 months before screening 5. Waist Circumference more than equal to 88 cm in women; more than equal to 102 cm in men. 6. Must follow a calorie-controlled diet and be willing to adhere to physical activity recommendations during the trial. 7. Subjects must provide signed and dated informed consent before screening procedures.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant, planning to become pregnant during the study, or currently breastfeeding will be excluded. Female subjects of childbearing potential must have a negative pregnancy test at screening and must agree to use effective contraception throughout the duration of the study. If a subject becomes pregnant during the study, she will be discontinued immediately, and appropriate follow-up procedures will be initiated to ensure safety. 2. Subjects with Type 1 Diabetes Mellitus will be excluded due to the differing metabolic mechanisms and treatment goals from those with Type 2 Diabetes Mellitus T2DM. 3. Subjects with a history of major cardiovascular events, including myocardial infarction, stroke, unstable angina, or heart failure NYHA Class III or IV in the past 6 months, will be excluded. This ensures patient safety, as weight loss medications may have cardiovascular effects. 4. Individuals with uncontrolled hypertension systolic blood pressure more than 180 mmHg or diastolic blood pressure more than 100 mmHg will be excluded. Properly managed blood pressure is essential, as fluctuations may complicate the trial. 5. Those with a history of eating disorders, such as anorexia nervosa, bulimia, or binge-eating disorder, will be excluded, as participation in a weight loss trial may exacerbate disordered eating behaviours. 6. Subjects with significant liver or kidney dysfunction, such as cirrhosis or end-stage renal disease eGFR less than 30 mL per min per 1.73 meter square, will be excluded due to the potential risks of drug accumulation and impaired metabolism of Korglutide. 7. Subjects who have undergone bariatric surgery or are planning to undergo such surgery during the study will be excluded. Surgical interventions for weight loss could confound the trials outcomes. 8. Endocrine tumours Multiple endocrine neoplasia, type 2 MEN 2 or if someone in your family had these tumours. 9. Individuals who have used weightloss medications such as phentermine, orlistat, liraglutide or participated in structured weight loss programs within 3 months before screening will be excluded to ensure the effects observed are from Korglutide alone. 10. Subjects with a history of acute or chronic pancreatitis and Gallbladder diseases will be excluded. Certain weight loss drugs have been associated with an increased risk of pancreatitis, and this risk must be minimized. 11. Subjects with any active malignancy or a history of malignancy in the past 5 years except for adequately treated non melanoma skin cancer will be excluded. This is to avoid complicating factors from cancer treatments or the disease itself. 12. Subjects with severe psychiatric disorders such as major depression, schizophrenia, or active substance abuse will be excluded, as these conditions could interfere with adherence to the study protocol and accurate reporting of adverse effects. 13. Subjects who have taken any investigational drug or participated in another clinical trial within the past 30 days will be excluded. This prevents interference from other untested treatments. 14. Subjects with known hypersensitivity to Korglutide or any of its components will be excluded from the trial to prevent adverse reactions. 15. Individuals with chronic gastrointestinal conditions like Crohns disease, ulcerative colitis, or irritable bowel syndrome that could affect nutrient absorption or me
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Korglutide compared to placebo in inducing weight loss over a 12-week treatment period in obese individuals with and without Type 2 diabetes.Timepoint: The primary efficacy endpoint will be the percent change in body weight from baseline to the end of the treatment period Baseline to Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of Subjects Achieving more than equal to 5 percent Weight Loss.Timepoint: Week 12;2. Proportion of Subjects Achieving more than 10 percent Weight Loss.Timepoint: Week 12;3. Change in Waist Circumference.Timepoint: Baseline, Week 12;4.Changes in HbA1c for Diabetic Cohort.Timepoint: Baseline, Week 12;5. Changes in Fasting Plasma Glucose.Timepoint: Baseline, Week 12;6. Changes in Lipid ProfileTimepoint: Baseline, Week 12;7. Changes in Blood PressureTimepoint: Baseline, Week 12 | — |
Countries
India
Contacts
Public ContactDr Aditi Datta
Biosite Research Private Limited
Outcome results
None listed