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Purpose

The purpose of this Phase-2 chronic weight management master protocol (CWMM) is to create a framework to evaluate the safety and efficacy of various investigational interventions for chronic weight management with intervention-specific appendices (ISAs). The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The ISAs may start independently of other ISAs as interventions become available for clinical testing. The results for the CWMM screening record will be reported when all the ISA's complete.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have a body mass index (BMI) - ≥30 kilogram/square meter (kg/m²), or - ≥27 kg/m² and <30 kg/m², or with at least 1 weight-related comorbidity - Have had a stable body weight for the 3 months prior to randomization (<5%) body weight gain and/or loss.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
Primary Purpose
Screening
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
LY3305677 Obesity ISA OXA1 		Participants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.
  • Drug: LY3305677
    Administered SC. ISA specific interventions will be listed in the ISA.
  • Drug: Placebo
    Administered SC. ISA specific interventions will be listed in the ISA.
Experimental
LY3841136 Obesity ISA LAA1 		Participants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.
  • Drug: LY3841136
    Administered SC. ISA specific interventions will be listed in the ISA.
  • Drug: Placebo
    Administered SC. ISA specific interventions will be listed in the ISA.
Experimental
LY3841136 Obesity ISA LAA2 		Participants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.
  • Drug: LY3841136
    Administered SC. ISA specific interventions will be listed in the ISA.
  • Drug: Tirzepatide
    Administered SC. ISA specific interventions will be listed in the ISA.
  • Drug: Placebo
    Administered SC. ISA specific interventions will be listed in the ISA.
Experimental
LY3549492 Obesity ISA GN01 		Participants will receive LY3549492 orally. Each ISA will detail the intervention specific analysis.
  • Drug: Placebo
    Administered SC. ISA specific interventions will be listed in the ISA.
  • Drug: LY3549492
    Administered orally. ISA specific interventions will be listed in the ISA.
Experimental
LY3549492 Obesity ISA GN02 		Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
  • Drug: Placebo
    Administered SC. ISA specific interventions will be listed in the ISA.
  • Drug: LY3549492
    Administered orally. ISA specific interventions will be listed in the ISA.

Recruiting Locations

The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler 5289282, Arizona 5551752 85225

HOPE Research Institute
Phoenix 5308655, Arizona 5551752 85032

Headlands Research - Scottsdale
Scottsdale 5313457, Arizona 5551752 85260
Contact:
480-725-8708

The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson 5318313, Arizona 5551752 85712
Contact:
480-470-4000

NorCal Medical Research, Inc
Greenbrae 5354013, California 5332921 94904
Contact:
415-461-1585

Velocity Clinical Research, Huntington Park
Huntington Park 5358736, California 5332921 90255
Contact:
323-588-1990

Peninsula Research Associates
Rolling Hills Estates 5388601, California 5332921 90274
Contact:
310-265-1623

Diablo Clinical Research, Inc.
Walnut Creek 5406990, California 5332921 94598
Contact:
925-930-7267

Stamford Therapeutics Consortium
Stamford 4843564, Connecticut 4831725 06905

Northeast Research Institute (NERI)
Fleming Island 4155594, Florida 4155751 32003
Contact:
904-541-8225

Indago Research & Health Center, Inc
Hialeah 4158476, Florida 4155751 33012
Contact:
305-825-6588

New Horizon Research Center
Miami 4164138, Florida 4155751 33165
Contact:
305-226-3933

Suncoast Clinical Research, Inc.
New Port Richey 4165869, Florida 4155751 34652
Contact:
727-849-4131

Charter Research - Winter Park
Orlando 4167147, Florida 4155751 32803
Contact:
407-337-1000

Charter Research - Lady Lake
The Villages 4175179, Florida 4155751 32162
Contact:
352-441-2000

Pacific Diabetes & Endocrine Center
Honolulu 5856195, Hawaii 5855797 96817
Contact:
808-526-0303

Medical Research Partners
Ammon 5583997, Idaho 5596512 83406
Contact:
208-681-9070

Great Lakes Clinical Trials - Andersonville
Chicago 4887398, Illinois 4896861 60640
Contact:
773-275-3500 Ext 126

Great Lakes Clinical Trials - Ravenswood
Chicago 4887398, Illinois 4896861 60640
Contact:
773-275-3500

NorthShore University Health System
Skokie 4911600, Illinois 4896861 60077
Contact:
847-663-8540

Iowa Diabetes and Endocrinology Research Center
West Des Moines 4881346, Iowa 4862182 50266
Contact:
515-329-6800

Cotton O'Neil Diabetes & Endocrinology
Topeka 4280539, Kansas 4273857 66606
Contact:
785-354-9591

L-MARC Research Center
Louisville 4299276, Kentucky 6254925 40213
Contact:
502-515-5672

Knownwell
Needham 4945055, Massachusetts 6254926 02492
Contact:
339-793-8998

Lucida Clinical Trials
New Bedford 4945121, Massachusetts 6254926 02740
Contact:
508-720-2015

Headlands Research - Detroit
Southfield 5010636, Michigan 5001836 48034
Contact:
248-243-1870

Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy 5012639, Michigan 5001836 48098
Contact:
248-312-0025

StudyMetrix Research
City of Saint Peters 4407237, Missouri 4398678 63303
Contact:
636-387-5100

Clinvest Headlands Llc
Springfield 4409896, Missouri 4398678 65807
Contact:
417-883-7889

Las Vegas Medical Research
Las Vegas 5506956, Nevada 5509151 89128
Contact:
702-750-0000

Dent Neurologic Institute
Amherst 5107129, New York 5128638 14226

Velocity Clinical Research, Syracuse
East Syracuse 5116079, New York 5128638 13057
Contact:
315-447-6359

North Suffolk Neurology
Port Jefferson Station 5132015, New York 5128638 11776
Contact:
631-364-9119

Rochester Clinical Research, LLC
Rochester 5134086, New York 5128638 14609
Contact:
585-288-0890

Medication Management
Greensboro 4469146, North Carolina 4482348 27405
Contact:
336-763-6968

Monroe Biomedical Research
Monroe 4479946, North Carolina 4482348 28112
Contact:
704-283-7359

Lucas Research, Inc
Morehead City 4480153, North Carolina 4482348 28557
Contact:
252-222-5700

Lucas Research, Inc.
New Bern 4481682, North Carolina 4482348 28562
Contact:
252-649-1944

CTI Clinical Research Center
Cincinnati 4508722, Ohio 5165418 45212
Contact:
513-721-3868

Tribe Clinical Research, LLC
Greenville 4580543, South Carolina 4597040 29607
Contact:
864-334-0141

Quality Medical Research
Nashville 4644585, Tennessee 4662168 37211
Contact:
615-835-4750

IMA Clinical Research Austin
Austin 4671654, Texas 4736286 78745
Contact:
512-649-0082

Velocity Clinical Research, Dallas
Dallas 4684888, Texas 4736286 75230
Contact:
682-348-1169

FutureSearch Trials of Dallas
Dallas 4684888, Texas 4736286 75251
Contact:
214-369-2600

PlanIt Research, PLLC
Houston 4699066, Texas 4736286 77079
Contact:
713-973-3415

Tekton Research - Fredericksburg Road
San Antonio 4726206, Texas 4736286 78229
Contact:
210-996-2600

Endeavor Clinical Trials
San Antonio 4726206, Texas 4736286 78240
Contact:
518-428-6859

Texas Valley Clinical Research
Weslaco 4740629, Texas 4736286 78596
Contact:
956-431-8090

Sovah Clinical Research-River District
Danville 4755280, Virginia 6254928 24541
Contact:
434-793-4711

Central Washington Health Services Association d/b/a Confluence Health
Wenatchee 5815342, Washington 5815135 98801
Contact:
509-436-4050

More Details

NCT ID
NCT06143956
Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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