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

Obesity Clinical Trial

Official title:

A Phase 2, Parallel-Group, Double-Blind, 4-Arm Study to Investigate Weight Management With LY3305677 Compared With Placebo and in Adult Participants With Obesity or Overweight

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06124807
• Other study ID #: 18661
• Secondary ID: W8M-MC-OXA1CWMM
• Status: Recruiting
• Phase: Phase 2
• Start date: November 17, 2023
• Est. completion date: May 16, 2025

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: May 16, 2025
• Est. primary completion date: November 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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) with at least one of the following weight-related comorbidities:

• hypertension: on blood pressure (BP)-lowering medication.

• dyslipidemia: on lipid-lowering medication

• cardiovascular (CV) disease: for example, ischemic CV disease, New York Heart Association (NYHA) Functional Classification Class 1 or II Heart Failure

• obstructive sleep apnea

• Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss).

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.

W8M-MC-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 any of the following cardiovascular conditions within 3 months prior to Screening:

• acute myocardial infarction

• cerebrovascular accident (stroke)

• unstable angina, or

• hospitalization due to congestive heart failure.

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

• Have a lifetime history of suicide attempts.

Related Conditions & MeSH terms

• Obesity
• Overweight
• Overweight and Obesity

Intervention

Drug:
• LY3305677
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Dent Neurologic Institute	Amherst	New York
United States	IMA Clinical Research Austin	Austin	Texas
United States	Great Lakes Clinical Trials - Andersonville	Chicago	Illinois
United States	Great Lakes Clinical Trials - Ravenswood	Chicago	Illinois
United States	CTI-CRC	Cincinnati	Ohio
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Spectrum Medical, Inc.	Danville	Virginia
United States	Northeast Research Institute (NERI)	Fleming Island	Florida
United States	Pacific Diabetes & Endocrine Center	Honolulu	Hawaii
United States	Endocrine Ips, Pllc	Houston	Texas
United States	National Research Institute - Huntington Park	Huntington Park	California
United States	Las Vegas Medical Research	Las Vegas	Nevada
United States	L-MARC Research Center	Louisville	Kentucky
United States	The Institute for Liver Health dba Arizona Clinical Trials	Mesa	Arizona
United States	Quality Medical Research	Nashville	Tennessee
United States	Knownwell	Needham	Massachusetts
United States	Lucas Research - New Bern	New Bern	North Carolina
United States	Suncoast Clinical Research, Inc.	New Port Richey	Florida
United States	Charter Research - Winter Park	Orlando	Florida
United States	North Suffolk Neurology	Port Jefferson Station	New York
United States	Peninsula Research Associates	Rolling Hills Estates	California
United States	StudyMetrix Research	Saint Peters	Missouri
United States	Tekton Research - Fredericksburg Road	San Antonio	Texas
United States	Headlands Research - Scottsdale	Scottsdale	Arizona
United States	Charter Research - Lady Lake	The Villages	Florida
United States	Cotton O'Neil Clinical Research Center	Topeka	Kansas
United States	The Institute for Liver Health II dba Arizona Liver Health-Tucson	Tucson	Arizona
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Central Washington Health Services Association d/b/a Confluence Health	Wenatchee	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change from Baseline in Body Weight		Baseline, Week 32
Secondary	Percent Change from Baseline in Body Weight		Baseline, Week 48
Secondary	Change from Baseline in Body Weight		Baseline, Week 32
Secondary	Change from Baseline in Body Weight		Baseline, Week 48
Secondary	Percentage of Participants Who Achieve =5% Body Weight Reduction		Baseline to Week 32
Secondary	Percentage of Participants Who Achieve =5% Body Weight Reduction		Baseline to Week 48
Secondary	Percentage of Participants Who Achieve =10% Body Weight Reduction		Baseline to Week 32
Secondary	Percentage of Participants Who Achieve =10% Body Weight Reduction		Baseline to Week 48
Secondary	Change from Baseline in Body Mass Index (BMI)		Baseline, Week 48
Secondary	Change from Baseline in BMI		Baseline, Week 32
Secondary	Absolute Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)		Baseline, Week 32
Secondary	Percent Change from Baseline in Liver Fat Content by MRI-PDFF		Baseline, Week 32
Secondary	Absolute Change from Baseline in Liver Fat Content by MRI-PDFF		Baseline, Week 48
Secondary	Percent Change from Baseline in Liver Fat Content by MRI-PDFF		Baseline, Week 48
Secondary	Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3305677		Baseline to Week 48
Secondary	PK: Maximum Concentration (Cmax) of LY3305677		Baseline to Week 48
Secondary	Number of Participants with Treatment Emergent Drug Antibodies (TE-ADAs)		Baseline to Week 56

External Links

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