Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Alkem s Semaglutide 0.25 mg, 0.5mg,1mg, 1.7mg, 2.4mg: Test product will be administered once weekly at anytime of day, with or without meals for 24 weeks.
Control Intervention1: Innovat
Sponsors
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: The patients will be included in the study based on the following criteria: 1.Willing to provide voluntary written informed consent and able to comply with the protocol requirements. 2. Male or female, age more than equal to 18 years at the time of signing informed consent 3. Body mass index (BMI) more than equal to 30 kg/m2 or more than equal to 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease. 4. History of at least one self-reported unsuccessful dietary effort to lose bodyweight 5. Sr. Calcitonin level of less than 50 ng/L at screening
Exclusion criteria
Exclusion criteria: The patients will be excluded from the study based on the following criteria: Glycaemia-related: 1. HbA1c more than equal to 48 mmol/mol (6.5%) at screening 2. History of type 1 or type 2 diabetes mellitus 3. Treatment with glucose-lowering agent(s) within 90 days before screening 4. Treatment with a GLP-1 receptor agonist within 180 days before screening. Obesity-related: 5. A self-reported gain in body weight by more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records 6. Treatment with any medication for the indication of obesity within the past 90 days before screening 7. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed more than 1 year before screening, (2) lap banding, if the band has been removed more than 1 year before screening, (3) intragastric balloon, if the balloon has been removed more than 1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed more than 1 year before screening 8. Uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) more than 6.0mIU/L or less than 0.4 mIU/L at screening. Mental health: 9. History of major depressive disorder within 2 years before screening 10. Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder) 11. Any lifetime history of a suicidal attempt or suicidal behavior within 30 days before screening 12. Suicidal ideation corresponding to type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening. General safety: 13. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening 14. Presence of acute pancreatitis within the past 180 days prior to the day of screening 15. History or presence of chronic pancreatitis 16. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma 17. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR less than 45 ml/min/1.73 m2 18. History of malignant neoplasms within the past 5 years prior to screening. 19. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 60 days prior to screening 20. Subject presently classified as being in New York Heart Association (NYHA) Class IV 21. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator 22. Known or suspected abuse of alcohol or recreational drugs 23. Known or suspected hypersensitivity to trial product(s) or related products 24. Participation in another clinical trial within 90 days before screening 25. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a effective contraceptive method during study period 26. Female Patient of child bearing potential using oral contraceptives. 27. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator s opinion, might jeopardize the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline to Week 24Timepoint: baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patient achieving more than 10% and more than 15% loss in body weight at 24 weeks Change BMI from baseline to Week 24 Change in waist circumference from baseline to week 24 Change in HbA1c from baseline to week 24 Proportion of patients with anti-drug antibodies (ADA) and neutralizing antibody from baseline to week 24 Timepoint: baseline to Week 24 | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratories Limited
Outcome results
None listed