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

May 11, 2026 updated by: Eli Lilly and Company

A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Interventions for Chronic Weight Management in Adult Participants With Obesity or Overweight

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The CWMM establishes entry criteria for newly enrolled participants across the master and the ISAs. The results for the CWMM screening record will be reported when all the ISA's complete.

Study Type

Interventional

Enrollment (Estimated)

1481

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1120AAC
        • Recruiting
        • Centro Medico Viamonte
        • Principal Investigator:
          • Diego Aizenberg
        • Contact:
          • Phone Number: 54 1149635650
      • Buenos Aires, Argentina, C1056ABI
        • Recruiting
        • Centro de Investigaciones Metabólicas (CINME)
        • Principal Investigator:
          • Federico Perez Manghi
        • Contact:
          • Phone Number: 08003450697
      • Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
        • Contact:
          • Phone Number: 5401148019001
        • Principal Investigator:
          • Evelyn Blanc
      • Buenos Aires, Argentina, 1424
        • Recruiting
        • Cicemo Srl
        • Contact:
          • Phone Number: 5491157417654
        • Principal Investigator:
          • Pablo Costanzo
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Recruiting
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
        • Principal Investigator:
          • Yessica Sachdeva
      • Phoenix, Arizona, United States, 85032
        • Recruiting
        • HOPE Research Institute
        • Principal Investigator:
          • Matthew Doust
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Headlands Research - Scottsdale
        • Contact:
          • Phone Number: 480-725-8708
        • Principal Investigator:
          • Benjamin Clark
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • The Institute for Liver Health II dba Arizona Liver Health-Tucson
        • Principal Investigator:
          • Anita Kohli
        • Contact:
          • Phone Number: 480-470-4000
    • California
      • Greenbrae, California, United States, 94904
        • Recruiting
        • NorCal Medical Research, Inc
        • Contact:
          • Phone Number: 415-461-1585
        • Principal Investigator:
          • Linda Gaudiani
      • Huntington Park, California, United States, 90255
        • Recruiting
        • Velocity Clinical Research, Huntington Park
        • Contact:
          • Phone Number: 323-588-1990
        • Principal Investigator:
          • Stanley Hsia
      • Rolling Hills Estates, California, United States, 90274
        • Recruiting
        • Peninsula Research Associates
        • Contact:
          • Phone Number: 310-265-1623
        • Principal Investigator:
          • Lawrence Sher
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Diablo Clinical Research, Inc.
        • Contact:
          • Phone Number: 925-930-7267
        • Principal Investigator:
          • Mark Christiansen
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • Stamford Therapeutics Consortium
        • Principal Investigator:
          • David Radin
    • Florida
      • Fleming Island, Florida, United States, 32003
        • Recruiting
        • Northeast Research Institute (NERI)
        • Contact:
          • Phone Number: 904-541-8225
        • Principal Investigator:
          • Senan Sultan
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Indago Research & Health Center, Inc
        • Principal Investigator:
          • Jose Cardona
        • Contact:
          • Phone Number: 305-825-6588
      • Miami, Florida, United States, 33165
        • Recruiting
        • New Horizon Research Center
        • Principal Investigator:
          • Lazaro Nunez
        • Contact:
          • Phone Number: 305-226-3933
      • New Port Richey, Florida, United States, 34652
        • Recruiting
        • Suncoast Clinical Research, Inc.
        • Contact:
          • Phone Number: 727-849-4131
        • Principal Investigator:
          • Cathy Barnes
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Charter Research - Winter Park
        • Principal Investigator:
          • Edgardo Rivera-Rivera
        • Contact:
          • Phone Number: 407-337-3000
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - Lady Lake
        • Contact:
          • Phone Number: 352-441-2000
        • Principal Investigator:
          • Jeffrey Norton
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Pacific Diabetes & Endocrine Center
        • Contact:
          • Phone Number: 808-526-0303
        • Principal Investigator:
          • ALAN PARSA
    • Idaho
      • Ammon, Idaho, United States, 83406
        • Recruiting
        • Medical Research Partners
        • Principal Investigator:
          • Joseph Moore
        • Contact:
          • Phone Number: 208-681-9070
    • Illinois
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Great Lakes Clinical Trials - Ravenswood
        • Principal Investigator:
          • Rupal Trivedi
        • Contact:
          • Phone Number: 773-275-3500 Ext 126
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Northshore University Health System
        • Contact:
          • Phone Number: 847-663-8540
        • Principal Investigator:
          • Liana Billings
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Iowa Diabetes and Endocrinology Research Center
        • Contact:
          • Phone Number: 515-329-6800
        • Principal Investigator:
          • Anuj Bhargava
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Diabetes & Endocrinology
        • Principal Investigator:
          • susan brian
        • Contact:
          • Phone Number: 785-354-9591
    • Kentucky
      • Louisville, Kentucky, United States, 40213
        • Recruiting
        • Monroe Biomedical Research - Louisville
        • Contact:
          • Phone Number: 502-515-5672
        • Principal Investigator:
          • Harold Bays
    • Massachusetts
      • Needham, Massachusetts, United States, 02492
        • Recruiting
        • Knownwell
        • Principal Investigator:
          • Angela Fitch
        • Contact:
          • Phone Number: 339-793-8998
      • New Bedford, Massachusetts, United States, 02740
        • Recruiting
        • Lucida Clinical Trials
        • Principal Investigator:
          • David Shih
        • Contact:
          • Phone Number: 508-720-2015
    • Michigan
      • Southfield, Michigan, United States, 48034
        • Recruiting
        • Headlands Research - Detroit
        • Principal Investigator:
          • Christopher Romero
      • Troy, Michigan, United States, 48098
        • Recruiting
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
        • Contact:
          • Phone Number: 248-312-0025
        • Principal Investigator:
          • Neil Fraser
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • Recruiting
        • StudyMetrix Research
        • Contact:
          • Phone Number: 636-387-5100
        • Principal Investigator:
          • Timothy Smith
      • Springfield, Missouri, United States, 65807
        • Recruiting
        • Clinvest Headlands Llc
        • Contact:
          • Phone Number: 417-883-7889
        • Principal Investigator:
          • Ralph Duda
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Medical Research
        • Principal Investigator:
          • Cornell Calinescu
        • Contact:
          • Phone Number: 702-750-0000
    • New York
      • Amherst, New York, United States, 14226
        • Recruiting
        • Dent Neurologic Institute
        • Principal Investigator:
          • Laszlo Mechtler
      • East Syracuse, New York, United States, 13057
        • Recruiting
        • Velocity Clinical Research, Syracuse
        • Principal Investigator:
          • Rachel Dubroff
      • Port Jefferson Station, New York, United States, 11776
        • Recruiting
        • North Suffolk Neurology
        • Principal Investigator:
          • Warren Spinner
        • Contact:
          • Phone Number: 631-364-9119
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research, LLC
        • Contact:
          • Phone Number: 585-288-0890
        • Principal Investigator:
          • Patrick Connors
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Medication Management
        • Contact:
          • Phone Number: 336-763-6968
        • Principal Investigator:
          • James Franklin
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
        • Contact:
          • Phone Number: 704-283-7359
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lucas Research, Inc
        • Principal Investigator:
          • Kathryn Lucas
        • Contact:
          • Phone Number: 252-222-5700
      • New Bern, North Carolina, United States, 28562
        • Recruiting
        • Lucas Research, Inc.
        • Principal Investigator:
          • Joseph Maides
    • Ohio
      • Cincinnati, Ohio, United States, 45212
        • Recruiting
        • CTI Clinical Research Center
        • Principal Investigator:
          • James Maynard
        • Contact:
          • Phone Number: 513-721-3868
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Tribe Clinical Research, LLC
        • Principal Investigator:
          • Ronald Mayfield
        • Contact:
          • Phone Number: 864-334-0141
    • Tennessee
      • Nashville, Tennessee, United States, 37211
        • Recruiting
        • Quality Medical Research
        • Principal Investigator:
          • Saras Sharma
        • Contact:
          • Phone Number: 615-835-4750
    • Texas
      • Austin, Texas, United States, 78745
        • Recruiting
        • IMA Clinical Research Austin
        • Principal Investigator:
          • Nomita Kim
        • Contact:
          • Phone Number: 512-649-0082
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Velocity Clinical Research, Dallas
        • Principal Investigator:
          • Dan Lender
      • Dallas, Texas, United States, 75251
        • Recruiting
        • FutureSearch Trials of Dallas
        • Principal Investigator:
          • Michael Downing
        • Contact:
          • Phone Number: 214-369-2600
      • Houston, Texas, United States, 77079
        • Recruiting
        • PlanIt Research, PLLC
        • Contact:
          • Phone Number: 713-973-3415
        • Principal Investigator:
          • Amer Al-Karadsheh
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Endeavor Clinical Trials
        • Principal Investigator:
          • Nitendra Agarwal
        • Contact:
          • Phone Number: 518-428-6859
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • Tekton Research - Fredericksburg Road
        • Contact:
          • Phone Number: 210-996-2600
        • Principal Investigator:
          • Jara McDonald
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Valley Clinical Research
        • Principal Investigator:
          • Eduardo Luna
        • Contact:
          • Phone Number: 956-431-8090
    • Virginia
      • Danville, Virginia, United States, 24541
        • Recruiting
        • Sovah Clinical Research-River District
        • Contact:
          • Phone Number: 434-793-4711
        • Principal Investigator:
          • Stephan Jannach
    • Washington
      • Wenatchee, Washington, United States, 98801
        • Recruiting
        • Central Washington Health Services Association d/b/a Confluence Health
        • Contact:
          • Phone Number: 509-436-4050
        • Principal Investigator:
          • Kathryn Eren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Placebo
Administered orally. 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: Placebo
Administered SC. ISA specific interventions will be listed in the ISA.
Drug: LY3841136
Administered SC. ISA specific interventions will be listed in the ISA.
Other Names:
  • Eloralintide
Drug: Placebo
Administered orally. 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: Placebo
Administered SC. ISA specific interventions will be listed in the ISA.
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 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: Placebo
Administered orally. 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 GN01

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: Placebo
Administered orally. ISA specific interventions will be listed in the ISA.
Drug: LY3549492
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: Placebo
Administered SC. ISA specific interventions will be listed in the ISA.
Drug: LY3841136
Administered SC. ISA specific interventions will be listed in the ISA.
Other Names:
  • Eloralintide
Drug: Placebo
Administered orally. ISA specific interventions will be listed in the ISA.
Drug: LY3532226
Administered SC. ISA specific interventions will be listed in the ISA.
Other Names:
  • Macupatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Allocated to Each ISA
Time Frame: Baseline to Week 6
Each ISA will detail the intervention specific analysis.
Baseline to Week 6

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2023

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

November 6, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Actual)

November 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18685
  • W8M-MC-OXA1 (Other Identifier: Eli Lilly and Company)
  • W8M-MC-CWMM (Other Identifier: Eli Lilly and Company)
  • W8M-MC-LAA1 (Other Identifier: Eli Lilly and Company)
  • W8M-MC-LAA2 (Other Identifier: Eli Lilly and Company)
  • W8M-MC-GN01 (Other Identifier: Eli Lilly and Company)
  • W8M-MC-GN02 (Other Identifier: Eli Lilly and Company)
  • W8M-MC-MC01 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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