Study to Investigate the Efficacy and Safety of Semaglutide of Intas Compared to Wegovy FlexTouch in Overweight and Obese Adult Participants in Adjunct to Diet and Exercise

Phase 3

Not yet recruiting

• Conditions: Endocrine, nutritional and metabolic diseases,

• Registration Number: CTRI/2025/06/089367
• Lead Sponsor: Intas Pharmaceuticals Limited

Brief Summary

This is a study to Investigate the Efficacy and Safety of Semaglutide of Intas Compared to Wegovy FlexTouch in Overweight and Obese Adult Participants in Adjunct to Diet and Exercise.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-02-07
• Last Update Posted: 2025-06-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 264

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 after the last dose of study intervention: Must agree not to plan to father a child or donate sperm for reproduction; PLUS, either of the following: Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR Must agree to use contraception barrier as detailed below: a male participant must wear a condom when engaging in any activity that allows for the passage of ejaculate to another person With female partner use of an additional highly effective contraceptive method with a failure rate of less than 1 percentage per year as described in Appendix 4 9) The participant with adequate haematologic, liver renal function and other parameters as mentioned below, at screening assessment.
• a) Calcitonin less than or equal to 50 ng per L b) Blood amylase less than or equal to 3 into ULN c) Blood lipase less than or equal to 3 into ULN d) Alkaline phosphatase less than or equal to 2 into ULN e) Alanine aminotransferase less than or equal to 2 into ULN f) Aspartate aminotransferase less than or equal to 2 into ULN g) Total bilirubin less than or equal to 1.5 into ULN h) Estimated glomerular filtration rate (eGFR) greater than 30ml per min per 1.73m2 as assessed by CKD-EPI 2021 equation including participants with end-stage renal disease i) Haemoglobin greater than or equal to 9 g per dL j) WBC count greater than or equal to 2500 per cu.mm k) Neutrophil count greater than or equal to 1500 per cu.mm l) Platelet count greater than or equal to 100,000 per cu.mm.

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. Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma.
• Family is defined as a first degree relative.
• 23. History or presence of malignancy within the past 5 years except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer.
• 24. Participant with uncontrolled hypertension with sitting systolic BP greater than or equal to 160 mmHg and per or diastolic BP greater than or equal to 100 mmHg at screening.
• 25. Participant with clinically significant current or recent (within the past 60 days prior to screening) cardiac conditions as defined below: a) Acute coronary syndrome, stroke [including transient ischemic attack (TIA)] or other ischemic event or thromboembolic event [e.g., deep vein thrombosis (DVT), pulmonary embolism] b) Clinical risk assessment of cardiac function using the New York Heart Association Functional Classification of Class III & IV26 26) Received any other investigational intervention or used an invasive investigational medical device within 3 months or 5 half-lives prior to the first dose of study intervention, whichever is longer.
• 27. Previous treatment with semaglutide.
• 28. Participants with medication history of herbal non-herbal medicine with unknown unspecified content within 90 days.
• 29. Participants with any abnormality on 12-lead ECG at screening that in the opinion of the Investigator is clinically significant and is judged as potential risk for his her participation in the study.
• 30. Surgery scheduled for the duration of the study, except for minor surgical procedures, in the opinion of the investigator.
• 31. Participation in another clinical study within 90 days before screening.
• 32. Documented medical history of uncontrolled, clinically significant intercurrent medical condition(s) for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.
• 33. Other causes of obesity can be excluded with documented history or known case of other endocrine diseases, including hypothalamic obesity, pituitary obesity, Cushings syndrome, acromegaly, hypogonadism etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To establish non-inferiority of semaglutidetest	Percent change in the body weight from | baseline to Week 24
compared to semaglutide-reference in	Percent change in the body weight from | baseline to Week 24
overweight and obese adult participants in	Percent change in the body weight from | baseline to Week 24
adjunct to diet and exercise	Percent change in the body weight from | baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
To establish non- inferiority of Semaglutide-	Test compared to semaglutide-reference in
To evaluate safety of semaglutide-test	compared to semaglutide-reference in
To evaluate immunogenicity of	semaglutide-test compared to semaglutidereference

Trial Locations

Locations (16)

Chellaram Diabetes lnstitute; 🇮🇳 Pune, MAHARASHTRA, India

Deenanath Mangeshkar Hospital and Research center; 🇮🇳 Pune, MAHARASHTRA, India

DHS Multispeciality Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dia care Research; 🇮🇳 Ahmadabad, GUJARAT, India

Life Line Diagnostics Centre Cum Nursing Home; 🇮🇳 Kolkata, WEST BENGAL, India

Maharaja Agrasen Superspeciality Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Marwari Hospitals; 🇮🇳 Golaghat, ASSAM, India

Navmeet Memorial Hospital "Sushrusha"; 🇮🇳 Ahmadabad, GUJARAT, India

PHC Prajna Healthcare; 🇮🇳 Ahmadabad, GUJARAT, India

RIMS Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

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Chellaram Diabetes lnstitute

🇮🇳Pune, MAHARASHTRA, India

DR A G Unnikrishnan

Principal investigator

8605011934

ceo@CDI.ORG.IN