A Master Protocol Study (LY900038) of Multiple Intervention-Specific-Appendices (ISAs) in Adult Participants With Obesity or Overweight

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

  • Obesity
  • Overweight

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.
    Other names:
    • Eloralintide
  • 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.
    Other names:
    • Eloralintide
  • Drug: Tirzepatide
    Administered SC. ISA specific interventions will be listed in the ISA.
    Other names:
    • LY3298176
  • Drug: Placebo
    Administered SC. ISA specific interventions will be listed in the ISA.
Experimental
LY3549492 Obesity ISA GN01 		Participants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
  • Drug: LY3549492
    Administered orally. ISA specific interventions will be listed in the ISA.
  • Drug: Placebo
    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: LY3549492
    Administered orally. ISA specific interventions will be listed in the ISA.
  • Drug: Placebo
    Administered orally. ISA specific interventions will be listed in the ISA.
Experimental
Obesity ISA MC01 		Participants will receive macupatide, eloralintide, and placebo SC. Each ISA will detail the intervention specific analysis.
  • Drug: LY3841136
    Administered SC. ISA specific interventions will be listed in the ISA.
    Other names:
    • Eloralintide
  • Drug: LY3532226
    Administered SC. ISA specific interventions will be listed in the ISA.
    Other names:
    • Macupatide
  • Drug: Placebo
    Administered SC. ISA specific interventions will be listed in the ISA.

Recruiting Locations

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

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

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

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

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

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

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

Stamford Therapeutics Consortium
Stamford, Connecticut 06905

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

Indago Research & Health Center, Inc
Miami Lakes, Florida 33016
Contact:
305-825-6588

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

Charter Research - Winter Park
Orlando, Florida 32803
Contact:
407-337-3000

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

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

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

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

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

Monroe Biomedical Research - Louisville
Louisville, Kentucky 40213
Contact:
502-515-5672

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

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

Headlands Research - Detroit
Southfield, Michigan 48034

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

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

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

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

Dent Neurologic Institute
Amherst, New York 14226

Velocity Clinical Research, Syracuse
East Syracuse, New York 13057

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

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

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

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

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

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

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

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

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

Velocity Clinical Research, Dallas
Dallas, Texas 75230

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

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

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

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

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

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

More Details

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