Health Condition 1: E00-E89- Endocrine, nutritional and metabolic diseases
Conditions
Interventions
Intervention1: Semaglutide-Test (T): Dose Formulation: single-dose solution for injection in pre-filled pen
Unit Dose Strengths: Semaglutide Injection 0.68 mg/mL, 1.5 mL (0.25 mg dose) Semaglutide Inj
Sponsors
Intas Pharmaceuticals Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Must sign an ICF indicating that the participant understands the purpose of, and procedures required for the study as described in Appendix 10.1.3 and in this protocol and is willing to participate in the study. 2) Male or female participants with Age of 18 to 65 years (both inclusive) at the time of signing the informed consent. 3) Body Mass Index (BMI) greater than or equal to 30 kg per m2 (Obese). OR BMI greater than or equal to 27 kg per m2 to less than 30 kg per m2 (overweight) in the presence of at least one weight-related comorbidity e.g. dysglycaemia (prediabetes or type 2 diabetes mellitus), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease at screening assessment. 4) Participants with Type 2 diabetes mellitus should additionally meet the following: Glycosylated Haemoglobin (HbA1c) greater than or equal to 7.5 percentage and less than 10.5 percentage at screening assessment. Participants who are on a stable treatment with metformin, sulphonylurea (SU) or metformin plus SU for at least 90 days before screening along with diet and exercise control. 5) History of at least one self-reported unsuccessful dietary effort to lose body weight. 6) Willing to comply with the dietary and physical activity requirement during the study. 7) Contraceptive use by participants or participant s partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) as defined in Appendix 4 OR Is a WOCBP and agrees to remain on an acceptable contraceptive method that is highly effective (with a failure rate of less than 1 percentage per year), preferably with low user dependency when used consistently and correctly, as described in Appendix 4 during the intervention period and for at least 2 months after the last dose of the study intervention. The investigator should evaluate the effectiveness and the potential for contraceptive method failure (e.g., noncompliance, recently initiated) of the contraceptive method in relation to the first dose of the study intervention. A WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their use during the recommended period of contraception. A WOCBP agrees to seek advice about donation and cryopreservation of germ cells. A WOCBP must have a negative highly sensitive serum B-human chorionic gonadotropin (BhCG) test at screening and urine BhCG test at Baseline. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. Additional requirements for pregnancy testing during and after study intervention are located in section 8.3.5. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk of inclusion of a woman with early undetected pregnancy. 8) Male participants are eligible to participate if they agree to the following during the intervention period and for at least 2 months af
Exclusion criteria
Exclusion criteria: 1) Known allergies, hypersensitivity, or intolerance to any of the study interventions & other GLP- 1 receptor agonists or components excipients thereof (refer to the SmPC of Wegovy) or drug or other allergies that, in the opinion of the investigator, contraindicate participation in the study. 2) Contraindications or limitations for administration of investigational intervention according to SmPC of Wegovy. Obesity related: 3) Treatment with any medication for the indication of obesity AND any medications affecting weight (other than oral contraceptives) within the past 90 days before screening. 4) A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records. 5) Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (a) liposuction and or abdominoplasty, if performed greater than 1 year before screening, (b) lap banding, if the band has been removed greater than 1 year before screening, (c) intragastric balloon, if the balloon has been removed greater than 1 year before screening or (d) duodenal-jejunal bypass sleeve, if the sleeve has been removed greater than 1 year before screening. Diabetes related: 6) 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 & treatment with GLP 1 RA within the past 180 days prior to screening. 7) Diagnosis of Type 1 diabetes. 8) Have a history of acute diabetic complications (diabetic ketoacidosis, lactic acidosis or hyperosmolar hyperglycaemic state) within 6 months before screening. 9) History of proliferative retinopathy or diabetic macular oedema, or any other unstable retinopathy (rapidly progressive) recorded in medical history and may require treatment during the study. Non-diabetic participants: 10) HbA1c greater than or equal to 5 percentage as measured at screening. Mental health: 11) Suicidal ideation corresponding to a yes answer on Question 4 or 5 on the Suicidal Thoughts portion of the Columbia-Suicide Severity Rating Scale (C-SSRS) within the past 30 days before screening. 12) History of major depressive disorder within 2 years before screening. 13) Diagnosis of other severe psychiatric disorder (e.g., schizophrenia, bipolar disorder). 14) Any lifetime history of a suicidal attempt. 15) Suicidal behaviour within 30 days before screening corresponding to a yes answer to any of the suicide-related behaviours (actual attempt, interrupted attempt, aborted attempt, preparatory act or behaviour) on the Suicidal Behaviour portion of the C-SSRS. 16) Patient Health Questionnaire-9 (PHQ-9) score of greater than or equal to 15 at screening. General safety: 17) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of investigational intervention. 18) Positive hepatitis C antibody test result at screening or within 3 months prior to the first dose of investigational intervention. 19) Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody test at screening. 20) F
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish non-inferiority of semaglutidetest compared to semaglutide-reference in overweight and obese adult participants in adjunct to diet and exerciseTimepoint: Percent change in the body weight from baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| To establish non- inferiority of Semaglutide- Test compared to semaglutide-reference in overweight & obese adult participants in adjunct to diet & exerciseTimepoint: a) Percent change in body weight from baseline to Week 4, 8, 12, 16 & 20 b) Mean change in absolute body weight from baseline to Week 4, 8, 12, 16, 20 & 24. c) Percentage of participants who achieve greater than or equal to 5 percentage, greater than or equal to 10 percentage body weight loss at Week 4, 8, 12, 16 & 24 d) Mean change in BMI from baseline to Week 4, 8, 12, 16, 20 & 24 e) Mean change in body waist circumference (cm) from baseline to Week 4, 8 12, 16, 20 & 24;To evaluate safety of semaglutide-test compared to semaglutide-reference in overweight and obese adult participants in adjunct to diet and exerciseTimepoint: Percentage of participants experiencing TEAE;To evaluate immunogenicity of semaglutide-test compared to semaglutidereference in overweight & obese adult participants in adjunct to diet & exerciseTimepoint: Proportion of participants with anti-drug antibodies (ADA) & neutralizing antibody (NAb) [Timeframe: Baseline (Pre-dose), Week 12, 20 & 24] | — |
Countries
India
Contacts
Public ContactDr Jogesh Mahajan
Lambda Therapeutic Research Ltd
Outcome results
None listed