Clinical trial NCT06230523: A Study of LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
Official title: A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY3841136 Compared With Placebo in Adult Participants With Obesity or Overweight
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Overweight and Obesity
Keywords: Overnutrition
Hormones
Chronic weight management
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-01-30
Enrollment: 250
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 the master protocol W8M-MC-CWMM (NCT06143956), is to investigate weight management efficacy and safety with LY3841136 compared with placebo in adult participants with obesity or overweight. The study will last about 64 weeks and may include up to 17 visits.


Eligibility criteria: Inclusion Criteria:

W8M-MC-LAA1

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

W8M-MC-CWMM:

* Have a BMI ≥27 kg/m²
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss)

Exclusion Criteria:

W8M-MC-LAA1

* Have any prior diagnosis 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 an on-going or history of bradyarrhythmia and/or sinus bradycardia at screening and baseline.

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 a history of symptomatic gallbladder disease within the past 2 years
* Have signs and symptoms of any liver disease other than nonalcoholic fatty liver disease.
* Have a lifetime history of suicide attempts.

Primary outcomes:
measure: Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 48
Secondary outcomes:
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 48
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, Week 48
measure: Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136
timeFrame: Baseline to Week 48
measure: PK: Maximum Concentration (Cmax) of LY3841136
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: Greenbrae
country: United States
facility: NorCal Medical Research, Inc
state: California
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: Ammon
country: United States
facility: Medical Research Partners
state: Idaho
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: Skokie
country: United States
facility: NorthShore University Health System
state: Illinois
city: West Des Moines
country: United States
facility: Iowa Diabetes and Endocrinology Research Center
state: Iowa
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: New Bedford
country: United States
facility: Lucida Clinical Trials
state: Massachusetts
city: Southfield
country: United States
facility: Headlands Research - Detroit
state: Michigan
city: Troy
country: United States
facility: Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
state: Michigan
city: Saint 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: East Syracuse
country: United States
facility: Velocity Clinical Research, Syracuse
state: New York
city: Port Jefferson Station
country: United States
facility: North Suffolk Neurology
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research, LLC
state: New York
city: Greensboro
country: United States
facility: Medication Management
state: North Carolina
city: Monroe
country: United States
facility: Monroe Biomedical Research
state: North Carolina
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: Greenville
country: United States
facility: Tribe Clinical Research, LLC
state: South Carolina
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: Dallas
country: United States
facility: FutureSearch Trials of 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: San Antonio
country: United States
facility: Endeavor Clinical Trials
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
city: Buenos Aires
country: Argentina
facility: Centro Médico Viamonte
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
state: Ciudad Autónoma De Buenos Aires
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)
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: