The effect of Tirzepatide once weekly on the morbidity and mortality of adults living with obesity.

Phase 3

Active, not recruiting

• Conditions: Obesity, unspecified,

• Registration Number: CTRI/2023/04/051445
• Lead Sponsor: Eli Lilly and Company India Pvt Ltd

Brief Summary

This study will investigate the effect of tirzepatide on the reduction of morbidity and mortality in adults living with obesity and provide additional evidence for the potential clinical benefits of tirzepatide in this population.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-04
• Last Update Posted: 2024-08-22

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 15000

Inclusion Criteria

• Have a body mass index (BMI) ≥27.0 kilogram/square meter (kg/m ²) 2.
• Are either -individuals ≥40 years of age with established cardiovascular disease (CVD).
• CVD is defined as meeting at least one of the following: Coronary artery disease Cerebrovascular disease -Peripheral arterial disease OR -individuals without established CVD but have the presence of cardiovascular (CV) risk factors (primary prevention): --women 55-69 years of age or men 50-64 years of age with at least 3 risk factors like tobacco use, dyslipidemia, hypertension at screening, or --women ≥70 years of age or men, ≥65 years of age with at least 2 risk factors at screening.

Exclusion Criteria

• Have type 1 diabetes (T1D) or (T2D), history of ketoacidosis, or hyperosmolar state/coma 2.
• Have laboratory evidence diagnostic of diabetes mellitus at screening of HbA1c ≥6.5% (≥48 millimole/mole (mmol/mol) or fasting glucose (FG) ≥126 milligram/deciliter (≥7.0 millimole/liter (mmol/L).
• Any one of the following CV conditions within 90 days prior to screening -MI -acute coronary syndrome -stroke -coronary or peripheral arterial revascularization procedure, which may also include carotid artery revascularization, or -acute decompensated heart failure 4.
• Have a known clinically significant gastric emptying abnormality such as severe gastroparesis or gastric outlet obstruction or have undergone or currently planning any gastric bypass (metabolic) surgery or restrictive bariatric surgery.
• Note: Liposuction or abdominoplasty are not considered as gastric bypass procedures.
• Have a history of chronic or acute pancreatitis 6.
• Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.
• Have acute or chronic hepatitis, or clinical signs or symptoms of any other liver disease, or have elevated liver enzyme measurements, determined by the central laboratory at screening 8.
• Have a presence or history of malignant neoplasms within the past 5 years prior to screening.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to First Occurrence of Any Component Event of Composite (All-Cause Death, Nonfatal Myocardial Infarction (MI), Nonfatal Stroke, Coronary Revascularization, or Heart Failure Events)	Up to 5 Years

Secondary Outcome Measures

Name	Time	Method
Hierarchical Composite of Renal Death or End-Stage Renal Disease (ESRD), Sustained Decline in Estimated Glomerular Filtration Rate (eGFR), and eGFR Slope	Baseline (Week 0) to Study Completion up to 5 Years.
Mean Change from Baseline Short Form-36 Version 2 (SF-36 v2) Acute Form Physical Functioning Domain Score	Baseline, 2 Years
1. Percent Change from Baseline in Body Weight	2. Change from Baseline in Systolic Blood Pressure (SBP) in Millimeter Mercury (mmHg)
1. Time to Onset of Type 2 Diabetes (T2D)	2. Time to First Occurrence of Any Component Event of Major Adverse Cardiovascular Events-3 (MACE-3) (CV Death, Nonfatal MI or Nonfatal Stroke)

Trial Locations

Locations (11)

Dayanand Medical College & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

G B Pant Institute of Postgraduate Medical Education and Research; 🇮🇳 Delhi, DELHI, India

Grant Government Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

Gujarat Endocrine Center; 🇮🇳 Ahmadabad, GUJARAT, India

K.E.M Hospital & Seth G. S. Medical College; 🇮🇳 Mumbai, MAHARASHTRA, India

King Georges Medical University; 🇮🇳 Lucknow, UTTAR PRADESH, India

Kingsway Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Nirmal Hospital Private Limited; 🇮🇳 Surat, GUJARAT, India

Osmania General Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Sardar Patel Medical College And A G Hospitals; 🇮🇳 Bikaner, RAJASTHAN, India

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Dayanand Medical College & Hospital

🇮🇳Ludhiana, PUNJAB, India

Dr Gurpreet Singh Wander

Principal investigator

01612304282

drgswander@yahoo.com