A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight

Last updated: April 9, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Not Recruiting

Phase

2

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

LY3305677

Placebo

Clinical Study ID

NCT06124807
18661
W8M-MC-OXA1
2022-502816-35-00
CWMM Master Protocol
  • Ages 18-75
  • All Genders

Study Summary

The main purpose of this study, performed under a master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3305677 compared with placebo and in adult participants with obesity or overweight. The study will last about 62 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria:

W8M-MC-OXA1:

  • Are males and females who agree to abide by the reproductive and contraceptiverequirements

W8M-MC-CWMM:

  • Have a BMI ≥27 kilograms per square meter (kg/m²)

Exclusion

Exclusion Criteria:

W8M-MC-OXA1:

  • Have any prior diagnosis of diabetes mellitus, that is type 2 diabetes mellitus (T2DM), or rare forms of diabetes mellitus, except gestational diabetes.

  • Have any of the following cardiovascular conditions within 6 months prior toscreening:

  • acute myocardial infarction

  • cerebrovascular accident (stroke)

  • unstable angina, or

  • hospitalization due to congestive heart failure (CHF).

  • Have a history of acute or chronic pancreatitis.

  • Have a history of New York Heart Association (NYHA) Functional ClassificationI-IV CHF.

  • Participants with hypertension who do not have well-controlled blood pressure (BP) (>140/90 mmHg), regardless of antihypertensive treatment. Participantsreceiving treatment for hypertension should be on a stable antihypertensiveregimen for at least 3 months prior to screening.

Note: If the investigator anticipates a need to add antihypertensive medication during the study, the participant should not be included in the ambulatory blood pressure monitoring (ABPM) procedures.

CWMM:

  • Have a prior or planned surgical treatment for obesity, except prior liposuction orabdominoplasty, if performed >1 year prior to screening.

  • Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history ofketoacidosis or hyperosmolar coma.

  • Have poorly controlled hypertension.

  • Have signs and symptoms of any liver disease other than nonalcoholic fatty liverdisease.

  • Have a history of symptomatic gallbladder disease within the past 2 years.

  • Have a lifetime history of suicide attempts.

Study Design

Total Participants: 179
Treatment Group(s): 2
Primary Treatment: LY3305677
Phase: 2
Study Start date:
November 17, 2023
Estimated Completion Date:
May 31, 2025

Connect with a study center

  • Centro Médico Viamonte

    Buenos Aires, Ciudad Autónoma De Buenos Aires C1120AAC
    Argentina

    Site Not Available

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Ciudad Autonoma de Buenos Aires, Ciudad Autónoma De Buenos Aires C1425AGC
    Argentina

    Site Not Available

  • Centro de Investigaciones Metabólicas (CINME)

    Ciudad Autónoma de Buenos Aires, C1056ABI
    Argentina

    Site Not Available

  • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

    Chandler, Arizona 85225
    United States

    Site Not Available

  • The Institute for Liver Health dba Arizona Clinical Trials

    Mesa, Arizona 85210
    United States

    Site Not Available

  • Headlands Research - Scottsdale

    Scottsdale, Arizona 85260
    United States

    Site Not Available

  • The Institute for Liver Health II dba Arizona Liver Health-Tucson

    Tucson, Arizona 85712
    United States

    Site Not Available

  • National Research Institute - Huntington Park

    Huntington Park, California 90255
    United States

    Active - Recruiting

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California 90255
    United States

    Site Not Available

  • Peninsula Research Associates

    Rolling Hills Estates, California 90274
    United States

    Site Not Available

  • Diablo Clinical Research, Inc.

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Northeast Research Institute (NERI)

    Fleming Island, Florida 32003
    United States

    Site Not Available

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida 34652
    United States

    Site Not Available

  • Charter Research - Winter Park

    Orlando, Florida 32803
    United States

    Site Not Available

  • Charter Research - Lady Lake

    The Villages, Florida 32162
    United States

    Site Not Available

  • Charter Research - Winter Park

    Winter Park, Florida 32792
    United States

    Site Not Available

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii 96817
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Cotton O'Neil Clinical Research Center

    Topeka, Kansas 66606
    United States

    Active - Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas 66606
    United States

    Site Not Available

  • L-MARC Research Center

    Louisville, Kentucky 40213
    United States

    Site Not Available

  • Knownwell

    Needham, Massachusetts 02492
    United States

    Site Not Available

  • Headlands Research - Detroit

    Southfield, Michigan 48034
    United States

    Site Not Available

  • StudyMetrix Research

    Saint Peters, Missouri 63303
    United States

    Site Not Available

  • StudyMetrix Research

    St. Peters, Missouri 63303
    United States

    Site Not Available

  • Las Vegas Medical Research

    Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Dent Neurologic Institute

    Amherst, New York 14226
    United States

    Site Not Available

  • Clarity Clinical Research

    East Syracuse, New York 13057
    United States

    Site Not Available

  • North Suffolk Neurology

    Port Jefferson Station, New York 11776
    United States

    Site Not Available

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Site Not Available

  • Lucas Research - New Bern

    New Bern, North Carolina 28562
    United States

    Active - Recruiting

  • Lucas Research, Inc.

    New Bern, North Carolina 28562
    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

  • Quality Medical Research

    Nashville, Tennessee 37211
    United States

    Site Not Available

  • IMA Clinical Research Austin

    Austin, Texas 78745
    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

  • Endocrine Ips, Pllc

    Houston, Texas 77079
    United States

    Active - Recruiting

  • PlanIt Research, PLLC

    Houston, Texas 77079
    United States

    Site Not Available

  • Tekton Research - Fredericksburg Road

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Spectrum Medical, Inc.

    Danville, Virginia 24541
    United States

    Site Not Available

  • Association d/b/a Confluence Health

    Wenatchee, Washington 98801
    United States

    Site Not Available

  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee, Washington 98801
    United States

    Site Not Available

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