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

NCT ID: NCT06124807

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-17

Study Completion Date

2025-07-09

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight and Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3305677 Dose 1

Participants will receive LY3305677 subcutaneously (SC).

Group Type EXPERIMENTAL

LY3305677

Intervention Type DRUG

Administered SC

LY3305677 Dose 2

Participants will receive LY3305677 SC.

Group Type EXPERIMENTAL

LY3305677

Intervention Type DRUG

Administered SC

LY3305677 Dose 3

Participants will receive LY3305677 SC.

Group Type EXPERIMENTAL

LY3305677

Intervention Type DRUG

Administered SC

Placebo

Participants will receive LY3305677 matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3305677

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

W8M-MC-OXA1:

* Are males and females who agree to abide by the reproductive and contraceptive requirements

W8M-MC-CWMM:

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

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 to screening:

* 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 Classification I-IV CHF.
* Participants with hypertension who do not have well-controlled blood pressure (BP) (\>140/90 mmHg), regardless of antihypertensive treatment. Participants receiving treatment for hypertension should be on a stable antihypertensive regimen 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 or abdominoplasty, if performed \>1 year prior to screening.
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults, or history of ketoacidosis or hyperosmolar coma.
* Have poorly controlled hypertension.
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have a history of symptomatic gallbladder disease within the past 2 years.
* Have a lifetime history of suicide attempts.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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

Eli Lilly and Company

Locations

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Great Lakes Clinical Trials - Ravenswood

Chicago, Illinois, United States

Site Status

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

Chandler, Arizona, United States

Site Status

Headlands Research - Scottsdale

Scottsdale, Arizona, United States

Site Status

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

Tucson, Arizona, United States

Site Status

Velocity Clinical Research, Huntington Park

Huntington Park, California, United States

Site Status

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Northeast Research Institute (NERI)

Fleming Island, Florida, United States

Site Status

Suncoast Clinical Research, Inc.

New Port Richey, Florida, United States

Site Status

Charter Research - Winter Park

Orlando, Florida, United States

Site Status

Charter Research - Lady Lake

The Villages, Florida, United States

Site Status

Pacific Diabetes & Endocrine Center

Honolulu, Hawaii, United States

Site Status

Great Lakes Clinical Trials - Andersonville

Chicago, Illinois, United States

Site Status

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, United States

Site Status

L-MARC Research Center

Louisville, Kentucky, United States

Site Status

Knownwell

Needham, Massachusetts, United States

Site Status

StudyMetrix Research

City of Saint Peters, Missouri, United States

Site Status

Las Vegas Medical Research

Las Vegas, Nevada, United States

Site Status

Dent Neurologic Institute

Amherst, New York, United States

Site Status

North Suffolk Neurology

Port Jefferson Station, New York, United States

Site Status

Lucas Research, Inc.

New Bern, North Carolina, United States

Site Status

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status

Quality Medical Research

Nashville, Tennessee, United States

Site Status

IMA Clinical Research Austin

Austin, Texas, United States

Site Status

Velocity Clinical Research, Dallas

Dallas, Texas, United States

Site Status

PlanIt Research, PLLC

Houston, Texas, United States

Site Status

Tekton Research - Fredericksburg Road

San Antonio, Texas, United States

Site Status

Spectrum Medical, Inc.

Danville, Virginia, United States

Site Status

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

Wenatchee, Washington, United States

Site Status

Countries

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United States

Related Links

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https://trials.lilly.com/en-US/trial/434975

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

Other Identifiers

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W8M-MC-OXA1

Identifier Type: OTHER

Identifier Source: secondary_id

CWMM Master Protocol

Identifier Type: OTHER

Identifier Source: secondary_id

2022-502816-35-00

Identifier Type: OTHER

Identifier Source: secondary_id

18661

Identifier Type: -

Identifier Source: org_study_id

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