Clinical trial NCT06662383: A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity
Official title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Retatrutide Compared to Tirzepatide in Adults Who Have Obesity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to evaluate the efficacy and safety of retatrutide compared to tirzepatide in adults who have obesity. The study will last about 89 weeks.


Eligibility criteria: Inclusion Criteria:

* Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.

Exclusion Criteria:

* Have a self-reported change in body weight \>5 kilograms (kg) (11 pounds) within 90 days before screening.
* Have a prior or planned surgical treatment for obesity.
* Have a prior or planned endoscopic procedure and/or device-based therapy for obesity.
* Have taken weight loss drugs, including over-the-counter medications, within 90 days prior to screening.
* Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
* Have had within the past 90 days before screening:

  * acute myocardial infarction
  * cerebrovascular accident (stroke)
  * coronary revascularization
  * hospitalization for unstable angina, or
  * hospitalization due to congestive heart failure.
* Have New York Heart Association Functional Classification Class IV congestive heart failure.
* Have a history of chronic or acute pancreatitis.

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 80
Secondary outcomes:
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline, Week 80
measure: Change from Baseline in Waist Circumference
timeFrame: Baseline, Week 80
measure: Percent Change from Baseline in Total Cholesterol
timeFrame: Baseline, Week 80
measure: Percent Change from Baseline in Triglycerides
timeFrame: Baseline, Week 80
measure: Change from Baseline in Systolic Blood Pressure (SBP)
timeFrame: Baseline, Week 80
measure: Change from Baseline in Diastolic Blood Pressure (DBP)
timeFrame: Baseline, Week 80
measure: Change from Baseline in Hemoglobin A1c (HbA1c)
timeFrame: Baseline, Week 80
measure: Percent Change from Baseline in Fasting Insulin
timeFrame: Baseline, Week 80
measure: Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
timeFrame: Baseline, Week 80
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Medical Advancement Centers of Arizona
state: Arizona
city: Newport Beach
country: United States
facility: Mary & Dick Allen Diabetes Center
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Spring Valley
country: United States
facility: Encompass Clinical Research
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Lynn Institute of Denver
state: Colorado
city: Bridgeport
country: United States
facility: Bridgeport Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Hollywood
country: United States
facility: Encore Medical Research
state: Florida
city: Miami
country: United States
facility: Suncoast Research Group
state: Florida
city: Miami
country: United States
facility: Onhealth Research Center
state: Florida
city: Sunrise
country: United States
facility: Precision Clinical Research
state: Florida
city: Vero Beach
country: United States
facility: Einstein Clinical Research
state: Florida
city: Columbus
country: United States
facility: ClinCept Clinical Research - MH
state: Georgia
city: Gainesville
country: United States
facility: Northeast Georgia Medical Center
state: Georgia
city: Stonecrest
country: United States
facility: Pivotal Research Solutions
state: Georgia
city: Honolulu
country: United States
facility: East-West Medical Research Institute
state: Hawaii
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: West Des Moines
country: United States
facility: Integrated Clinical Trial Services, Inc.
state: Iowa
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Bay City
country: United States
facility: Great Lakes Research Group, Inc.
state: Michigan
city: Southfield
country: United States
facility: Great Lakes Research Institute
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Henderson
country: United States
facility: Las Vegas Endocrinology
state: Nevada
city: Albany
country: United States
facility: Albany Medical College, Division of Community Endocrinology
state: New York
city: New York
country: United States
facility: New York Gastroenterology Associates
state: New York
city: Valhalla
country: United States
facility: Westchester Medical Center
state: New York
city: Greensboro
country: United States
facility: PharmQuest Life Sciences, LLC
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare - Wilmington
state: North Carolina
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Dayton
country: United States
facility: PriMED Clinical Research
state: Ohio
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: Brownsville
country: United States
facility: Headlands Horizons LLC
state: Texas
city: Houston
country: United States
facility: Next Level Urgent Care
state: Texas
city: Houston
country: United States
facility: Houston Research Institute
state: Texas
city: Shavano Park
country: United States
facility: Consano Clinical Research, LLC
state: Texas
city: Saint George
country: United States
facility: Chrysalis Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: Charlottesville Medical Research
state: Virginia
city: Ramos Mejía
country: Argentina
facility: DIM Clínica Privada
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Consultorio de Investigación Clínica EMO SRL
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
city: Villingen-Schwenningen
country: Germany
facility: Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob
state: Baden-Württemberg
city: Lingen
country: Germany
facility: Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz
state: Niedersachsen
city: Essen
country: Germany
facility: InnoDiab Forschung Gmbh
state: Nordrhein-Westfalen
city: Essen
country: Germany
facility: Medizentrum Essen Borbeck
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Zentrum fur klinische Forschung - Köln
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: AmBeNet GmbH
state: Sachsen
city: Oldenburg
country: Germany
facility: RED-Institut GmbH
state: Schleswig-Holstein
city: Hamburg
country: Germany
facility: Diabetes Zentrum Wilhelmsburg
city: Hamburg
country: Germany
facility: Diabeteszentrum Hamburg West
city: Lublin
country: Poland
facility: Gabinety TERPA
state: Lubelskie
city: Lublin
country: Poland
facility: Ekamed
state: Lubelskie
city: Bialystok
country: Poland
facility: Gabinet Leczenia Otylosci i Chorob Dietozaleznych - dr hab. n. med. Lucyna Ostrowska
state: Podlaskie
city: Bialystok
country: Poland
facility: Zdrowie Osteo-Medic
state: Podlaskie
city: Bialystok
country: Poland
facility: NZOZ Specjalistyczny Ośrodek Internistyczno-Diabetologiczny
state: Podlaskie
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Białymstoku
state: Podlaskie
city: Poznan
country: Poland
facility: Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
state: Wielkopolskie
city: Poznań
country: Poland
facility: Centrum Zdrowia Metabolicznego Pawel Bogdanski
state: Wielkopolskie
city: Lodz
country: Poland
facility: Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
state: Łódzkie
city: Ruda Slaska
country: Poland
facility: NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
state: Śląskie
city: Ponce
country: Puerto Rico
facility: Ponce Medical School Foundation Inc.
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: