A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
- Conditions
- ObesityOverweight and Obesity
- Interventions
- Drug: Placebo
- Registration Number
- NCT06124807
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 179
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)
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LY3305677 Dose 3 LY3305677 Participants will receive LY3305677 SC. LY3305677 Dose 1 LY3305677 Participants will receive LY3305677 subcutaneously (SC). LY3305677 Dose 2 LY3305677 Participants will receive LY3305677 SC. Placebo Placebo Participants will receive LY3305677 matching placebo.
- Primary Outcome Measures
Name Time Method Percent Change from Baseline in Body Weight Baseline to Week 32
- Secondary Outcome Measures
Name Time Method Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3305677 Baseline to Week 56 Absolute Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC ≥5% and Baseline LFC≥10% Baseline to Week 48 Change from Baseline in Body Weight Baseline, Week 48 Percent Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC ≥5% and Baseline LFC≥10% Baseline, Week 48 Percent Change from Baseline in Body Weight Baseline, Week 48 PK: Maximum Concentration (Cmax) of LY3305677 Baseline to Week 56 Percentage of Participants Who Achieve ≥5% Body Weight Reduction Baseline to Week 48 Percentage of Participants Who Achieve ≥10% Body Weight Reduction Baseline to Week 48 Change from Baseline in Body Mass Index (BMI) Baseline to Week 32 Change from Baseline in BMI Baseline to Week 48 Number of Participants with Treatment Emergent Drug Antibodies (TE-ADAs) Baseline to Week 56 Absolute Change from Baseline in Liver Fat Content (LFC) by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) in Participants with Baseline LFC≥5% and Baseline LFC≥10% Baseline to Week 32 Percent Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC≥5% and Baseline LFC≥10% Baseline to Week 32 Percentage of Participants Who Achieve ≥30% Relative Reduction in LFC Baseline to Week 32 Percentage of Participants Who Achieve >30% Relative Reduction in LFC Baseline to Week 48
Trial Locations
- Locations (29)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
🇺🇸Chandler, Arizona, United States
Headlands Research - Scottsdale
🇺🇸Scottsdale, Arizona, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
🇺🇸Tucson, Arizona, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Peninsula Research Associates
🇺🇸Rolling Hills Estates, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Northeast Research Institute (NERI)
🇺🇸Fleming Island, Florida, United States
Suncoast Clinical Research, Inc.
🇺🇸New Port Richey, Florida, United States
Charter Research - Winter Park
🇺🇸Orlando, Florida, United States
Charter Research - Lady Lake
🇺🇸The Villages, Florida, United States
Pacific Diabetes & Endocrine Center
🇺🇸Honolulu, Hawaii, United States
Great Lakes Clinical Trials - Andersonville
🇺🇸Chicago, Illinois, United States
Great Lakes Clinical Trials - Ravenswood
🇺🇸Chicago, Illinois, United States
Cotton O'Neil Diabetes & Endocrinology
🇺🇸Topeka, Kansas, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Knownwell
🇺🇸Needham, Massachusetts, United States
StudyMetrix Research
🇺🇸St. Peters, Missouri, United States
Las Vegas Medical Research
🇺🇸Las Vegas, Nevada, United States
Dent Neurologic Institute
🇺🇸Amherst, New York, United States
North Suffolk Neurology
🇺🇸Port Jefferson Station, New York, United States
Lucas Research, Inc.
🇺🇸New Bern, North Carolina, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Quality Medical Research
🇺🇸Nashville, Tennessee, United States
IMA Clinical Research Austin
🇺🇸Austin, Texas, United States
Velocity Clinical Research, Dallas
🇺🇸Dallas, Texas, United States
PlanIt Research, PLLC
🇺🇸Houston, Texas, United States
Tekton Research - Fredericksburg Road
🇺🇸San Antonio, Texas, United States
Spectrum Medical, Inc.
🇺🇸Danville, Virginia, United States
Central Washington Health Services Association d/b/a Confluence Health
🇺🇸Wenatchee, Washington, United States