Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Hetero-Semaglutide: A prefilled pen injector once weekly (on the same day each week) as subcutaneous injection in abdomen, thigh or upper arm. Th initial dose will be 0.25 mg weekly for
Sponsors
Hetero Labs Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects of either gender, aged greater than or equal to 18 years to less than or equal to 65 years. 2. Body mass index (BMI) greater than or equal to 27 kg per meter square to less than 30 kg per meter square with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidemia, obstructive sleep apnoea, cardiovascular disease or dysglycemia (prediabetes or type 2 diabetes mellitus) OR greater than or equal to 30 kg per meter square with or without comorbidities at screening and randomization 3. For T2DM Subjects at screening: a. T2DM diagnosed greater than or equal to 180 days prior to screening b. T2DM subjects on stable dose on metformin for at least greater than or equal to 90 days prior to screening c. T2DM subjects with HbA1C 8 percentage-10 percentage
Exclusion criteria
Exclusion criteria: 1. History of type 1 diabetes mellitus 2. Known/current diabetic retinopathy in patients with type 2 diabetes. 3. Treatment with glucose-lowering agent(s) agents which can result in weight gain (such as insulin, Thiazolidinediones, Sulfonylureas) or weight loss (SLT2i, dual GIP-GLP RA) prescribed for the indication of diabetes mellitus within 90 days before screening. 4. Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening 5. Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. 6. Hamilton Depression Rating Scale (HAM-D) greater than or equal to total item score 10 or greater than or equal to 2 on suicide item on HAM-D -17 item scale at screening. 7. Subjects with the following laboratory abnormalities at screening a. Alanine aminotransferase (ALT) greater than or equal to 3 ULN b. Aspartate aminotransferase (AST) greater than or equal to 3 ULN c. Total bilirubin (TBiL) greater than or equal to3 ULN d. Serum Calcitonin greater than 50ng/L e. Serum amylase greater than or equal to 3 ULN f. Serum lipase greater than or equal to 3 ULN g. Serum creatinine greater than or equal to 1.5 mg per dL in males or greater than or equal to 1.4 mg per dL in females
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percentage reduction in body weightTimepoint: Baseline to 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change in systolic blood pressure (SBP) (mmHg) and diastolic blood pressure (DBP) (mmHg)Timepoint: Baseline to 12 and 24 weeks;Mean change in total cholesterol, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol and triglyceridesTimepoint: Screening to 12 and 24 weeks;Mean change in glycated hemoglobin (HbA1c) in type 2 diabetes mellitus (T2DM) subjectsTimepoint: Screening to 12 and 24 weeks;Mean change in fasting plasma glucose (FPG) and post prandial plasma glucose (PPG) in T2DM subjectsTimepoint: Baseline to 4, 8, 12, 16, 20 and 24 weeks;Change in quality of life by short form survey (SF-36) scoresTimepoint: Baseline to 12 and 24 weeks;Proportion of subjects with anti-drug antibody ADA) to SemaglutideTimepoint: Baseline to 12 and 24 weeks;Treatment emergent adverse events by monitoring significant clinical signs, symptoms and laboratory abnormalitiesTimepoint: All visits;Proportion of subjects with body weight reduction of at least 5%Timepoint: At 12 and 24 weeks;Proportion of subjects with body weight reduction greater than or equal to 10%Timepoint: At 12 and 24 weeks;Proportion of subjects with body weight reduction greater than or equal to 15%Timepoint: At 12 and 24 weeks;Mean change in waist circumference (cm)Timepoint: Baseline to 12 and 24 weeks;Mean change in waist hip ratio (WHR)Timepoint: Baseline to 12 and 24 weeks;Mean change in body mass index (BMI) (kg per meter square)Timepoint: Baseline to 12 and 24 weeks | — |
Countries
India
Contacts
Public ContactMohan Reddy Bandi
Hetero Labs Limited
Outcome results
None listed