Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Semaglutide Injection of SPIL (0.25mg/0.5mg/1mg/1.7mg/2.4mg): Subcutaneous injection once weekly, on the same day each week, at any time of day, with or without meals from Day 1 to week
Sponsors
Sun Pharmaceutical Industries Limited (SPIL)
Sun Pharmaceutical Industries Limited
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria for all patients: 1. Male or female, aged 18 to 65 years (both inclusive) at the time of signing informed consent 2. Body mass index (BMI) greater than or equal to 30 kg/m2 or greater than or equal to 27 kg/m2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia or type 2 diabetes mellitus (T2DM) at screening and randomization 3. Patients and their female partners of childbearing potential should agree to use contraceptive measures throughout the study and for at least 2 months after end of treatment. (Note: Acceptable methods of contraception: A. Male: Vasectomy, Condoms, Total abstinence; B. Females: hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total sexual abstinence) Inclusion Criteria applicable for Type 2 Diabetes Mellitus patients: 4. Diagnosed with T2D greater than or equal to 180 days prior to the day of screening 5. Subjects who are on a stable treatment with metformin, sulphonylurea (SU) or metformin + SU for at least 90 days before screening along with diet and exercise control.
Exclusion criteria
Exclusion criteria: Exclusion Criteria for all patients: 1. History of type 1 diabetes mellitus 2. Treatment with a GLP-1 receptor agonist within 180 days before screening 3. Treatment with Semaglutide previously 4. A self-reported change in body weight greater than 5 kg within 90 days before screening irrespective of medical records 5. Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed: liposuction and/or abdominoplasty, if performed greater than 1 year before screening, lap banding, if the band has been removed greater than 1 year before screening, intragastric balloon, if the balloon has been removed greater than 1 year before screening or duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year before screening 6. History of OR presence of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder etc.) 7. History of Suicidal behaviour or suicidal ideation within 30 days before screening 8. Calcitonin greater than or equal to 100 ng/L at screening 9. Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma 10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR lesser than 30ml/min/1.73m2 [Note: eGFR will be calculated using MDRD formula] 11. Patients with aspartate transaminase [AST] greater than 2 x upper limit of normal [ULN] OR alanine transaminase [ALT] greater than 2 x ULN OR alkaline phosphatase [ALP] greater than 2 x ULN OR serum bilirubin greater than 1.5 x ULN) at Screening 12. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed 13. Known or suspected abuse of alcohol or recreational drugs 14. Known or suspected hypersensitivity to trial product(s) or related products 15. Participation in another clinical trial within 90 days before screening 16. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method 17. Any disorder, which in the investigator s opinion, might jeopardise the subject s safety or compliance with the protocol Exclusion criteria for Non -Diabetic Patients: 18. HbA1c greater than or equal to 6.5% as measured at screening Exclusion criteria for Diabetic Patients: 19. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within the past 90 days prior day of screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weightTimepoint: From Baseline to week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in FBG (For Non-diabetic patients only)Timepoint: From baseline to week 24;Change in PPBG (For Non-diabetic patients only)Timepoint: From baseline to week 24;Treatment Emergent Adverse Events (TEAEs)Timepoint: Throughout the study period;Proportion of patients with anti-drug antibody (ADA) and Neutralising antibody (Nab) positiveTimepoint: Baseline and at week 24;Percentage change in body weight (For all patients)Timepoint: From baseline to week 4, 8, 12, 16 and 20;Proportion of patients having body weight reduction greater than or equal to 5% (For all patients)Timepoint: From baseline at week 4, 8, 12, 16, 20 and 24;Proportion of patients having body weight reduction greater than or equal to 10 % (For all patients)Timepoint: From baseline at week 4, 8,12, 16, 20 and 24;Change in BMI (For all patients)Timepoint: From baseline to week 4, 8, 12, 16, 20 and 24;Change in waist circumference (For all patients)Timepoint: From baseline to week 4, 8, 12, 16, 20 and 24;Change in SF-36 total score (For all patients)Timepoint: From baseline to week 4, 8, 12, 16, 20 and 24;Change in glycosylated hemoglobin (For Diabetic patients only)Timepoint: From baseline to week 12 and 24;Change in FBG (For Diabetic patients only)Timepoint: From baseline to week 4, 8, 12, 16, 20 and 24;Change in PPBG (For Diabetic patients only)Timepoint: From baseline to week 4, 8, 12, 16, 20 and 24;Change in glycosylated hemoglobin (For Non-diabetic patients only)Timepoint: From baseline to week 24 | — |
Countries
India
Contacts
Public ContactChaitali Bornare
Sun Pharma Laboratories Limited
Outcome results
None listed