A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
- Registration Number
- NCT05822830
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 751
- Have a body mass index (BMI) of ≥30 kilogram per square meter (kg/m²) or ≥27 kg/m² and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- Have a history of at least 1 unsuccessful dietary effort to lose body weight
- Diabetes mellitus
- Change in body weight greater than 5 kg within 3 months prior to starting study
- Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tirzepatide Tirzepatide Participants will receive tirzepatide subcutaneously (SC). Semaglutide Semaglutide Participants will receive semaglutide SC.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline, Week 72
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve ≥15% Body Weight Reduction Week 72 Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg Baseline, Week 72 Percentage of Participants Who Achieve ≥25% Body Weight Reduction Week 72 Change from Baseline in Waist Circumference in Centimeter (cm) Baseline, Week 72 Percentage of Participants Who Achieve ≥20% Body Weight Reduction Week 72 Percentage of Participants Who Achieve ≥30% Body Weight Reduction Week 72 Change from Baseline in Body Mass Index (BMI) Baseline, Week 72 Percentage of Participants Who Achieve ≥10% Body Weight Reduction Week 72
Trial Locations
- Locations (32)
Cahaba Research
🇺🇸Birmingham, Alabama, United States
Cahaba Research - Pelham
🇺🇸Pelham, Alabama, United States
Southern California Dermatology, Inc.
🇺🇸Santa Ana, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Velocity Clinical Research, Hallandale Beach
🇺🇸Hallandale Beach, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Rophe Adult and Pediatric Medicine/SKYCRNG
🇺🇸Union City, Georgia, United States
Rocky Mountain Clinical Research
🇺🇸Idaho Falls, Idaho, United States
Scroll for more (22 remaining)Cahaba Research🇺🇸Birmingham, Alabama, United States