A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

Last updated: April 17, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

2

Condition

Diabetes Prevention

Obesity

Treatment

Mibavademab

Tirzepatide

Tirzepatide-Placebo

Clinical Study ID

NCT06373146
18750
I8F-MC-GPIV
  • Ages > 18
  • All Genders

Study Summary

The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Have a body mass index (BMI) of ≥30 kilogram/square meter (kg/m²) and ≤40 kg/m²

  • Willing to learn how to self-inject study intervention (visually impaired personswho are not able to perform the injections must have the assistance of a sightedindividual trained to inject the study intervention; persons with physicallimitations who are not able to perform the injections must have the assistance ofan individual trained to inject the study intervention)

  • Male or female contraceptive use by participant should be consistent with localregulations regarding the methods of contraception for those participating inclinical studies.

Exclusion

Exclusion Criteria:

  • Have a history of diabetes mellitus, including Type 1 Diabetes Mellitus (T1DM) orType 2 Diabetes Mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma

  • Have a self-reported change (increase or decrease) in body weight >5 kilogram (kg)within 3 months prior to screening

  • Have a family or personal history of medullary thyroid carcinoma (MTC) or multipleendocrine neoplasia (MEN) syndrome type 2

  • Have acute or chronic hepatitis

  • Have a history of an active or untreated malignancy or are in remission from aclinically significant malignancy for less than 5 years

Study Design

Total Participants: 360
Treatment Group(s): 4
Primary Treatment: Mibavademab
Phase: 2
Study Start date:
April 24, 2024
Estimated Completion Date:
April 30, 2026

Connect with a study center

  • Centro de Investigacion en Artritis y Osteoporosis SC

    Mexicali, Baja California 21200
    Mexico

    Site Not Available

  • Clínicos Asociados BOCM

    Mexico City, Distrito Federal 03300
    Mexico

    Site Not Available

  • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)

    Guadalajara, Jalisco 44340
    Mexico

    Site Not Available

  • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León 66460
    Mexico

    Site Not Available

  • Unidad biomedica avanzada monterrey

    Monterrey, Nuevo León 64460
    Mexico

    Site Not Available

  • Medical Care and Research SA de CV

    Merida, Yucatán 97070
    Mexico

    Site Not Available

  • Enclifar Ensayos Clínicos Farmacológicos Sc

    Chihuahua, 31110
    Mexico

    Site Not Available

  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

    Chihuahua, 31110
    Mexico

    Site Not Available

  • Velocity Clinical Research, Gardena

    Gardena, California 90247
    United States

    Site Not Available

  • Irvine Clinical Research

    Irvine, California 92614
    United States

    Site Not Available

  • National Research Institute - Wilshire

    Los Angeles, California 90057
    United States

    Active - Recruiting

  • Velocity Clinical Research, Westlake

    Los Angeles, California 90017
    United States

    Site Not Available

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California 91606
    United States

    Site Not Available

  • Velocity Clinical Research, Panorama City

    Panorama City, California 91402
    United States

    Site Not Available

  • Velocity Clinical Research, Santa Ana

    Santa Ana, California 92704
    United States

    Site Not Available

  • Velocity Clinical Research, Panorama City

    Van Nuys, California 91405
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Solaris Clinical Research

    Meridian, Idaho 83646
    United States

    Site Not Available

  • Tandem Clinical Research

    Marrero, Louisiana 70072
    United States

    Site Not Available

  • Velocity Clinical Research, Metairie

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Velocity Clinical Research - New Orleans

    New Orleans, Louisiana 70119
    United States

    Site Not Available

  • Velocity Clinical Research, Norfolk

    Norfolk, Nebraska 68701
    United States

    Site Not Available

  • CenExel-HRI

    Berlin, New Jersey 08009
    United States

    Active - Recruiting

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Hassman Research Institute Marlton Site

    Marlton, New Jersey 08053
    United States

    Site Not Available

  • Lillestol Research

    Fargo, North Dakota 58104
    United States

    Site Not Available

  • CTI Clinical Research Center

    Cincinnati, Ohio 45212
    United States

    Site Not Available

  • CTI-CRC

    Cincinnati, Ohio 45212
    United States

    Active - Recruiting

  • South Texas Clinical Research

    Corpus Christi, Texas 78404
    United States

    Site Not Available

  • Dallas Diabetes Research Center

    Dallas, Texas 75230
    United States

    Active - Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas 75230
    United States

    Site Not Available

  • Juno Research

    Houston, Texas 77040
    United States

    Site Not Available

  • Northwest Clinical Research Center

    Bellevue, Washington 98007
    United States

    Site Not Available

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