A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Phase 3

Completed

• Conditions: Overweight; Obesity
• Interventions: Drug: Tirzepatide; Drug: Semaglutide

• 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

Study Timeline

• Study First Submitted: 2022-09-16
• Study First Submitted QC: 2023-04-10
• Study Start: 2023-04-21
• Study First Posted: 2023-04-21
• Primary Completion: 2024-11-13
• Study Completion: 2024-11-13
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-06
• Last Update Posted: 2024-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 751

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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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)

Southern California Dermatology, Inc.; 🇺🇸 Santa Ana, California, United States

University Clinical Investigators, Inc.; 🇺🇸 Tustin, California, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Lillestol Research; 🇺🇸 Fargo, North Dakota, United States

New Horizon Research Center; 🇺🇸 Miami, Florida, United States

Tribe Clinical Research, LLC; 🇺🇸 Greenville, South Carolina, United States

Palm Research Center Sunset; 🇺🇸 Las Vegas, Nevada, United States

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division; 🇺🇸 Troy, Michigan, United States

Velocity Clinical Research, Hallandale Beach; 🇺🇸 Hallandale Beach, Florida, United States

Palm Research Center Tenaya; 🇺🇸 Las Vegas, Nevada, United States

Prime Health and Wellness/SKYCRNG; 🇺🇸 Fayette, Mississippi, United States

Puerto Rico Medical Research; 🇵🇷 Ponce, Puerto Rico

Wellness clinical Research Vega Baja; 🇵🇷 Vega Baja, Puerto Rico

WR-Clinsearch, LLC; 🇺🇸 Chattanooga, Tennessee, United States

Rocky Mountain Clinical Research; 🇺🇸 Idaho Falls, Idaho, United States

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

Cahaba Research; 🇺🇸 Birmingham, Alabama, United States

Cahaba Research - Pelham; 🇺🇸 Pelham, Alabama, United States

Encompass Clinical Research; 🇺🇸 Spring Valley, California, United States

Iowa Diabetes and Endocrinology Research Center; 🇺🇸 West Des Moines, Iowa, United States

Rophe Adult and Pediatric Medicine/SKYCRNG; 🇺🇸 Union City, Georgia, United States

StudyMetrix Research; 🇺🇸 Saint Peters, Missouri, United States

PharmQuest; 🇺🇸 Greensboro, North Carolina, United States

Alliance for Multispecialty Research, LLC; 🇺🇸 Norman, Oklahoma, United States

The University of Texas Health Science Center at Houston; 🇺🇸 Bellaire, Texas, United States

Dallas Diabetes Research Center; 🇺🇸 Dallas, Texas, United States

North Texas Endocrine Center; 🇺🇸 Dallas, Texas, United States

Biopharma Informatic, LLC; 🇺🇸 Houston, Texas, United States

PlanIt Research, PLLC; 🇺🇸 Houston, Texas, United States

Pinnacle Clinical Research; 🇺🇸 San Antonio, Texas, United States

Southern Endocrinology Associates; 🇺🇸 Mesquite, Texas, United States

L-MARC Research Center; 🇺🇸 Louisville, Kentucky, United States