Clinical trial NCT06124807: A Study of LY3305677 Compared With Placebo in Adult Participants With Obesity or Overweight
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight and Obesity
Keywords: Incretins
Weight Loss
Overnutrition
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-11-09
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline to Week 32
Secondary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 48
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 32
measure: Change from Baseline in Body Weight
timeFrame: Baseline, Week 48
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Baseline to Week 32
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Baseline to Week 48
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Baseline to Week 32
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Baseline to Week 48
measure: Change from Baseline in Body Mass Index (BMI)
timeFrame: Baseline to Week 32
measure: Change from Baseline in BMI
timeFrame: Baseline to Week 48
measure: Number of Participants with Treatment Emergent Drug Antibodies (TE-ADAs)
timeFrame: Baseline to Week 56
measure: Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3305677
timeFrame: Baseline to Week 56
measure: PK: Maximum Concentration (Cmax) of LY3305677
timeFrame: Baseline to Week 56
measure: 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%
timeFrame: Baseline to Week 32
measure: Percent Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC≥5% and Baseline LFC≥10%
timeFrame: Baseline to Week 32
measure: Absolute Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC ≥5% and Baseline LFC≥10%
timeFrame: Baseline to Week 48
measure: Percent Change from Baseline in Liver Fat Content by MRI-PDFF in Participants with Baseline LFC ≥5% and Baseline LFC≥10%
timeFrame: Baseline, Week 48
measure: Percentage of Participants Who Achieve ≥30% Relative Reduction in LFC
timeFrame: Baseline to Week 32
measure: Percentage of Participants Who Achieve >30% Relative Reduction in LFC
timeFrame: Baseline to Week 48
Other outcomes:
Locations:
city: Chandler
country: United States
facility: The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
state: Arizona
city: Scottsdale
country: United States
facility: Headlands Research - Scottsdale
state: Arizona
city: Tucson
country: United States
facility: The Institute for Liver Health II dba Arizona Liver Health-Tucson
state: Arizona
city: Huntington Park
country: United States
facility: Velocity Clinical Research, Huntington Park
state: California
city: Rolling Hills Estates
country: United States
facility: Peninsula Research Associates
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Fleming Island
country: United States
facility: Northeast Research Institute (NERI)
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research, Inc.
state: Florida
city: Orlando
country: United States
facility: Charter Research - Winter Park
state: Florida
city: The Villages
country: United States
facility: Charter Research - Lady Lake
state: Florida
city: Honolulu
country: United States
facility: Pacific Diabetes & Endocrine Center
state: Hawaii
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Andersonville
state: Illinois
city: Chicago
country: United States
facility: Great Lakes Clinical Trials - Ravenswood
state: Illinois
city: Topeka
country: United States
facility: Cotton O'Neil Diabetes & Endocrinology
state: Kansas
city: Louisville
country: United States
facility: L-MARC Research Center
state: Kentucky
city: Needham
country: United States
facility: Knownwell
state: Massachusetts
city: St. Peters
country: United States
facility: StudyMetrix Research
state: Missouri
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Amherst
country: United States
facility: Dent Neurologic Institute
state: New York
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology
state: New York
city: New Bern
country: United States
facility: Lucas Research, Inc.
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Austin
country: United States
facility: IMA Clinical Research Austin
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Houston
country: United States
facility: PlanIt Research, PLLC
state: Texas
city: San Antonio
country: United States
facility: Tekton Research - Fredericksburg Road
state: Texas
city: Danville
country: United States
facility: Spectrum Medical, Inc.
state: Virginia
city: Wenatchee
country: United States
facility: Central Washington Health Services Association d/b/a Confluence Health
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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
References: