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A Study of Retatrutide (LY3437943) Compared to Tirzepatide (LY3298176) in Adults Who Have Obesity

Phase 3
Recruiting
Conditions
Obesity
Interventions
Drug: Tirzepatide
Drug: Retatrutide
Registration Number
NCT06662383
Lead Sponsor
Eli Lilly and Company
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
800
Inclusion Criteria
  • Have obesity and a history of at least one self-reported unsuccessful dietary effort to reduce body weight.
Read More
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.

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TirzepatideTirzepatideParticipants will receive tirzepatide administered SC
RetatrutideRetatrutideParticipants will receive retatrutide administered subcutaneously (SC)
Primary Outcome Measures
NameTimeMethod
Percent Change from Baseline in Body WeightBaseline, Week 80
Secondary Outcome Measures
NameTimeMethod
Change from Baseline in Body Mass Index (BMI)Baseline, Week 80
Change from Baseline in Waist CircumferenceBaseline, Week 80
Percent Change from Baseline in Total CholesterolBaseline, Week 80
Percent Change from Baseline in TriglyceridesBaseline, Week 80
Change from Baseline in Systolic Blood Pressure (SBP)Baseline, Week 80
Change from Baseline in Diastolic Blood Pressure (DBP)Baseline, Week 80
Change from Baseline in Hemoglobin A1c (HbA1c)Baseline, Week 80
Percent Change from Baseline in Fasting InsulinBaseline, Week 80
Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)Baseline, Week 80

Trial Locations

Locations (65)

Albany Medical College, Division of Community Endocrinology

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Albany, New York, United States

Medical Advancement Centers of Arizona

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Tempe, Arizona, United States

Mary & Dick Allen Diabetes Center

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Newport Beach, California, United States

Artemis Institute for Clinical Research

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San Diego, California, United States

Encompass Clinical Research

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Spring Valley, California, United States

Diablo Clinical Research, Inc.

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Walnut Creek, California, United States

Lynn Institute of Denver

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Aurora, Colorado, United States

Bridgeport Hospital

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Bridgeport, Connecticut, United States

Yale University School of Medicine

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New Haven, Connecticut, United States

Encore Medical Research

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Hollywood, Florida, United States

Suncoast Research Group

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Miami, Florida, United States

Onhealth Research Center

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Miami, Florida, United States

Precision Clinical Research

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Sunrise, Florida, United States

Einstein Clinical Research

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Vero Beach, Florida, United States

ClinCept Clinical Research - MH

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Columbus, Georgia, United States

Northeast Georgia Medical Center

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Gainesville, Georgia, United States

Pivotal Research Solutions

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Stonecrest, Georgia, United States

East-West Medical Research Institute

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Honolulu, Hawaii, United States

Northwestern University

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Chicago, Illinois, United States

Integrated Clinical Trial Services, Inc.

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West Des Moines, Iowa, United States

Pennington Biomedical Research Center

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Baton Rouge, Louisiana, United States

Great Lakes Research Group, Inc.

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Bay City, Michigan, United States

Great Lakes Research Institute

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Southfield, Michigan, United States

StudyMetrix Research

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Saint Peters, Missouri, United States

Las Vegas Endocrinology

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Henderson, Nevada, United States

New York Gastroenterology Associates

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New York, New York, United States

Westchester Medical Center

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Valhalla, New York, United States

PharmQuest Life Sciences, LLC

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Greensboro, North Carolina, United States

Monroe Biomedical Research

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Monroe, North Carolina, United States

Accellacare - Wilmington

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Wilmington, North Carolina, United States

Lillestol Research

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Fargo, North Dakota, United States

PriMED Clinical Research

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Dayton, Ohio, United States

Tribe Clinical Research, LLC

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Greenville, South Carolina, United States

WR-Clinsearch, LLC

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Chattanooga, Tennessee, United States

Headlands Horizons LLC

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Brownsville, Texas, United States

Next Level Urgent Care

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Houston, Texas, United States

Houston Research Institute

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Houston, Texas, United States

Consano Clinical Research, LLC

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Shavano Park, Texas, United States

Chrysalis Clinical Research

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Saint George, Utah, United States

Charlottesville Medical Research

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Charlottesville, Virginia, United States

DIM Cl铆nica Privada

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Ramos Mej铆a, Buenos Aires, Argentina

Centro M茅dico Viamonte

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Buenos Aires, Ciudad Aut贸noma De Buenos Aires, Argentina

NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki

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Ruda Slaska, 艢l膮skie, Poland

Consultorio de Investigaci贸n Cl铆nica EMO SRL

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Ciudad Autonoma de Buenos Aires, Ciudad Aut贸noma De Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

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Ciudad Autonoma de Buenos Aires, Ciudad Aut贸noma De Buenos Aires, Argentina

Centro de Investigaciones Metab贸licas (CINME)

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Ciudad Aut贸noma de Buenos Aires, Argentina

Gemeinschaftspraxis Prof. Dr. med. Stephan Jacob, Dr. med. Frohmut Jacob

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Villingen-Schwenningen, Baden-W眉rttemberg, Germany

Diabetologische Schwerpunktpraxis Dr. Staudenmeyer & Dr. Schiwietz

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Lingen, Niedersachsen, Germany

InnoDiab Forschung Gmbh

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Essen, Nordrhein-Westfalen, Germany

Medizentrum Essen Borbeck

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Essen, Nordrhein-Westfalen, Germany

Zentrum fur klinische Forschung - K枚ln

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K枚ln, Nordrhein-Westfalen, Germany

AmBeNet GmbH

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Leipzig, Sachsen, Germany

RED-Institut GmbH

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Oldenburg, Schleswig-Holstein, Germany

Diabetes Zentrum Wilhelmsburg

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Hamburg, Germany

Diabeteszentrum Hamburg West

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Hamburg, Germany

Gabinety TERPA

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Lublin, Lubelskie, Poland

Ekamed

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Lublin, Lubelskie, Poland

Gabinet Leczenia Otylosci i Chorob Dietozaleznych - dr hab. n. med. Lucyna Ostrowska

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Bialystok, Podlaskie, Poland

Zdrowie Osteo-Medic

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Bialystok, Podlaskie, Poland

NZOZ Specjalistyczny O艣rodek Internistyczno-Diabetologiczny

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Bialystok, Podlaskie, Poland

Uniwersytecki Szpital Kliniczny w Bia艂ymstoku

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Bia艂ystok, Podlaskie, Poland

Nzoz Neuro-Kard Ilkowski i Partnerzy SPL

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Poznan, Wielkopolskie, Poland

Centrum Zdrowia Metabolicznego Pawel Bogdanski

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Pozna艅, Wielkopolskie, Poland

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

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Lodz, 艁贸dzkie, Poland

Ponce Medical School Foundation Inc.

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Ponce, Puerto Rico

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