Health Condition 1: E669- Obesity, unspecified Health Condition 2: E663- Overweight
Conditions
Interventions
Intervention1: Semaglutide Injection pre-filled pen: A dose of 0.25 mg, 0.50 mg, 1 mg, 1.7 mg and 2.4 mg will be injected subcutaneously in stomach (abdomen), thigh, or upper arm once a week with or w
Sponsors
Emcure Pharmaceuticals Ltd., India
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects with 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). 2) Subjects with a history of at least one self-reported unsuccessful dietary effort to lose body weight. 3) Subjects willing to comply with the dietary and physical activity requirement during the study. 4) Subjects 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 study. (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] hormonal contraception, intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total sexual abstinence). 5) Subject with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 6) Subjects willing to comply with the protocol requirements. 7) Subjects with glycosylated haemoglobin (HbA1c) 7.0 percent - 10.0 percent (both inclusive) at screening visit. 8) Subjects diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening. 9) Subjects who are on a stable treatment with up to three oral glucose-lowering agents (Metformin, sulfonylureas, SGLT2 inhibitors, or Thiazolidinediones) for at least 90 days before screening along with diet and exercise control.
Exclusion criteria
Exclusion criteria: 1) Subjects with a history of type 1 diabetes mellitus. 2) Previous treatment with a GLP-1 receptor agonist (GLP-1 RA) 3) A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before screening irrespective of medical records. 4) Treatment with any medication for the indication of obesity within the past 90 days before screening. 5) Previous or planned (during the trial period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a. Liposuction and/or abdominoplasty, if performed more than 1 year before screening, b. Lap banding, if the band has been removed more 1 year before screening, c. Intragastric balloon if the balloon has been removed more 1 year before screening or d. Duodenal-jejunal bypass sleeve if the sleeve has been removed more than 1 year before screening. 6) Subjects with uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) greater than 6.0 mIU/L or less than 0.4 mIU/L. 7) Serologic examination: a. human immunodeficiency virus antibody or treponema pallidum antibody positive; b. hepatitis C antibody positive; c. hepatitis B surface antigen (HBsAg) is positive, and the quantitative test result of hepatitis B virus DNA is higher than the upper limit of the reference range; 8) Subjects with a history of major depressive disorder within 2 years before screening. 9) Subjects with a history of or diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder etc.). 10) A lifetime history of a suicidal attempt. 11) Subjects with a history of suicidal behaviour or suicidal ideation within 30 days before screening. 12) Subjects having Hamilton Depression Rating Scale (HAM-D; 17 items) total score greater than or equal to 10, and/or a score of greater than or equal to 2 on Suicide item of HAM-D 17-items scale at screening. 13) Subjects with the use of any herbal/ non-herbal medicine with unknown/unspecified content within 90 days before screening. 14) Subjects with a history or presence of pancreatitis. 15) Serum calcitonin greater than or equal to 50 ng/L at screening. 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 30ml/min/1.73 m2 [Note: estimated glomerular filtration rate (eGFR) will be calculated using Modification of Diet in Renal Disease (MDRD) formula]. 18) Subjects with aspartate transaminase [AST] greater than 1.5 x upper limit of normal [ULN] OR alanine transaminase [ALT] greater than 1.5 x ULN OR alkaline phosphatase [ALP] greater than 1.5 x ULN OR total bilirubin greater than 1.5 x ULN) at screening. 19) Subjects with a 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. 20) Subjects with a history of myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 60 days prior to screening. 21) Subjects with a presence of heart failure classified as being in New York Heart Association (NYHA) Class II, III and IV. 22) Surgery scheduled for the duration of the trial, except for minor surgical proce
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weightTimepoint: Baseline visit to end of treatment (Week 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change in body weightTimepoint: Baseline to week 4, 8, 12, 16 and 20;Proportion of subjects having body weight reduction greater than or equal to 10 percentTimepoint: Baseline at week 4, 8, 12, 16, 20 and 24;Change in BMITimepoint: Baseline to week 4, 8, 12, 16, 20 and 24;Change in waist circumferenceTimepoint: Baseline to week 4, 8, 12, 16, 20 and 24;Change in Physical functioning score (SF) 36 total scoreTimepoint: Baseline to week 4, 8, 12, 16, 20 and 24;Change in glycosylated haemoglobin % (HbA1c %)Timepoint: Baseline to week 12 and week 24;Change in fasting plasma glucose (FPG)Timepoint: Baseline to week 4, 8, 12, 16, 20 and 24.;Change in post prandial glucose (PPG)Timepoint: Baseline to week 4, 8, 12, 16, 20 and 24.;Treatment emergent adverse events (TEAE) and Serious adverse events (SAE)Timepoint: Reported during entire study | — |
Countries
India
Contacts
Public ContactDr Milan Satia
Ethicare Clinical Trial Services (OPC) Pvt. Ltd.
Outcome results
None listed