Clinical trial NCT05822830: A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities
Official title: A Phase 3b, Randomized Controlled Study to Evaluate the Efficacy and Safety of Tirzepatide Compared to Semaglutide in Adults Who Have Obesity or Overweight With Weight Related Comorbidities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Overweight
Keywords: Metabolism and Nutrition
Disorder
Prediabetes
Diet
Exercise
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-04-21
Enrollment: 751
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Phase 3b
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 72
Secondary outcomes:
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥20% Body Weight Reduction
timeFrame: Week 72
measure: Percentage of Participants Who Achieve ≥25% Body Weight Reduction
timeFrame: Week 72
measure: Change from Baseline in Waist Circumference in Centimeter (cm)
timeFrame: Baseline, Week 72
measure: Percentage of Participants Who Achieve ≥30% Body Weight Reduction
timeFrame: Week 72
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 72
measure: Percent Change from Baseline in Body Weight comparing tirzepatide 15 mg and semaglutide 2.4 mg
timeFrame: Baseline, Week 72
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cahaba Research
state: Alabama
city: Pelham
country: United States
facility: Cahaba Research - Pelham
state: Alabama
city: Santa Ana
country: United States
facility: Southern California Dermatology, Inc.
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Tustin
country: United States
facility: University Clinical Investigators, Inc.
state: California
city: Hallandale Beach
country: United States
facility: Velocity Clinical Research, Hallandale Beach
state: Florida
city: Miami
country: United States
facility: New Horizon Research Center
state: Florida
city: Tampa
country: United States
facility: ForCare Clinical Research
state: Florida
city: Union City
country: United States
facility: Rophe Adult and Pediatric Medicine/SKYCRNG
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Fayette
country: United States
facility: Prime Health and Wellness/SKYCRNG
state: Mississippi
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Las Vegas
country: United States
facility: Palm Research Center Tenaya
state: Nevada
city: Las Vegas
country: United States
facility: Palm Research Center Sunset
state: Nevada
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Greensboro
country: United States
facility: PharmQuest
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Norman
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Oklahoma
city: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
city: Chattanooga
country: United States
facility: WR-Clinsearch, LLC
state: Tennessee
city: Bellaire
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes Research Center
state: Texas
city: Dallas
country: United States
facility: North Texas Endocrine Center
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic, LLC
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: Mesquite
country: United States
facility: Southern Endocrinology Associates
state: Texas
city: San Antonio
country: United States
facility: Pinnacle Clinical Research
state: Texas
city: Ponce
country: Puerto Rico
facility: Puerto Rico Medical Research
city: Vega Baja
country: Puerto Rico
facility: Wellness clinical Research Vega Baja
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: