Health Condition 1: E669- Obesity, unspecified Health Condition 2: E669- Obesity, unspecified
Conditions
Sponsors
Zydus Lifesciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 to 75 years (both inclusive) at the time of signing informed consent. 2. Patients 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). 3. Patients with a history of at least one self-reported unsuccessful dietary effort to lose body weight. 4. Patients willing to comply with the dietary and physical activity requirement during the study. 5. 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] hormonal contraception, intrauterine devices, intrauterine hormone releasing system, bilateral tubal occlusion, or total sexual abstinence). 6. Patient with ability to understand and provide written informed consent form, which must have been obtained prior to screening. 7. Patients willing to comply with the protocol requirements. Inclusion Criteria Applicable for Type 2 Diabetes Mellitus Patients: 8. Patients with glycosylated haemoglobin (HbA1c) 7.0% - 10.0% (both inclusive) at screening visit. 9. Patients diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening. 10. Patients 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. Patients with a history of type 1 diabetes mellitus. 2. Treatment with a GLP-1 receptor agonist (GLP-1 RA) within 180 days before screening. 3. Treatment with Semaglutide previously. 4. A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records. 5. Treatment with any medication for the indication of obesity within the past 90 days before screening. 6. 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. 7. Patients with uncontrolled thyroid disease, defined as thyroid stimulating hormone (TSH) greater than 6.0 mIU/L or less than 0.4 mIU/L. 8. Patients with a history of major depressive disorder within 2 years before screening. 9. Patients 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. Patients with a history of suicidal behaviour or suicidal ideation within 30 days before screening. 12. Patients 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. Patients with the use of any herbal/ non-herbal medicine with unknown/unspecified content within 90 days before screening. 14. Patients with a history or presence of pancreatitis. 15. 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. Patients 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. Patients 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. Patients 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. Patients 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 procedures, in the opinion of the investigator. 23. Patients with known or suspected abuse of alcohol or recreational drugs. 24. Patients with known or suspected hypersensitivity to trial product(s) or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage change in body weight from baseline to week 24.Timepoint: Baseline and Week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients having body weight reduction more than or equal to 10 % from baseline at week 4, 8, 12, 16, 20 and 24.Timepoint: Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.;Percentage change in body weight from baseline to week 4, 8, 12, 16 and 20.Timepoint: Baseline, Week 4, Week 8, Week 12, Week 16 and Week 20.;Proportion of patients having body weight reduction more than or equal to 5% from baseline at week 4, 8 12, 16, 20 and 24.Timepoint: Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.;Change in BMI from baseline to week 4, 8, 12, 16, 20 and 24.Timepoint: Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.;Change in waist circumference from baseline to week 4, 8, 12, 16, 20 and 24.Timepoint: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.;Change in Physical functioning score (SF) 36 total score from baseline to week 4, 8, 12, 16 and 24.Timepoint: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.;For Diabetic Patients Change in glycosylated hemoglobin from baseline to week 12 and 24. Timepoint: Baseline, Week 12 and Week 24.;For Diabetic Patients Change in FPG & PPG from baseline to week 4, 8, 12, 16, 20 and 24. Timepoint: Baseline, Week 4, Week 8, Week 12, Week 16, Week 20 and Week 24.;For Non-diabetic patients Change in glycosylated hemoglobin, FPG & PPG from baseline to week 24. Timepoint: Baseline and Week 24.;Adverse events & Serious adverse events (SAE) reported during the study. Timepoint: Throughout the study.;Number of patients discontinued due to AEs during course of trial.Timepoint: Throughout the study.;Number of patients requiring hypoglycaemia management (for diabetic patients only).Timepoint: Throughout the study.;Proportion of patients with anti-drug antibodies (ADA) and Neutralizing Antibody (Nab) at week 24 compared to pre-dose (enrolment, Day 0 - visit 2).Timepoint: Day 0 and Week 24. | — |
Countries
India
Contacts
Public ContactDr Hardik Pathak
Zydus Lifesciences Limited
Outcome results
None listed