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ObesityPhase 2NCT06143956

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

A Phase 2 study testing LY3305677, LY3841136 and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 57 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Obesity, Overweight
What is being tested?
LY3305677, LY3841136 and Tirzepatide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,481 participants
Where
57 sitesin 2 countries
Study dates
17 Nov 2023to Feb 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

57 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact

1-317-615-4559

LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact contact

clinical_inquiry_hub@lilly.com

57 sites in 2 countries

United States50 sites, 43 recruiting

  • Dent Neurologic Institute

    Amherst, New York, 14226

    Laszlo Mechtler

    Recruiting

  • Medical Research Partners

    Ammon, Idaho, 83406

    208-681-9070

    Joseph Moore

    Recruiting

  • IMA Clinical Research Austin

    Austin, Texas, 78745

    512-649-0082

    Nomita Kim

    Recruiting

  • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa

    Chandler, Arizona, 85225

    Yessica Sachdeva

    Recruiting

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

    Active, not recruiting

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

    773-275-3500 Ext 162

    Rupal Trivedi

    Recruiting

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

    513-721-3868

    James Maynard

    Recruiting

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

    636-387-5100

    Timothy Smith

    Recruiting

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

    Dan Lender

    Recruiting

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75251

    214-369-2600

    Michael Downing

    Recruiting

  • Sovah Clinical Research-River District

    Danville, Virginia, 24541

    434-793-4711

    Stephan Jannach

    Recruiting

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York, 13057

    Rachel Dubroff

    Recruiting

  • Northeast Research Institute (NERI)

    Fleming Island, Florida, 32003

    Completed

  • NorCal Medical Research, Inc

    Greenbrae, California, 94904

    415-461-1585

    Linda Gaudiani

    Recruiting

  • Medication Management

    Greensboro, North Carolina, 27401

    336-763-6968

    James Franklin

    Recruiting

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

    864-334-0141

    Ronald Mayfield

    Recruiting

  • Pacific Diabetes & Endocrine Center

    Honolulu, Hawaii, 96817

    Completed

  • PlanIt Research, PLLC

    Houston, Texas, 77079

    713-973-3415

    Amer Al-Karadsheh

    Recruiting

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

    323-588-1990

    Stanley Hsia

    Recruiting

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

    702-750-0000

    Cornell Calinescu

    Recruiting

  • Monroe Biomedical Research - Louisville

    Louisville, Kentucky, 40213

    502-515-5672

    Harold Bays

    Recruiting

  • New Horizon Research Center

    Miami, Florida, 33165

    305-226-3933

    Lazaro Nunez

    Recruiting

  • Indago Research & Health Center, Inc

    Miami Lakes, Florida, 33016

    305-825-6588

    Jose Cardona

    Recruiting

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

    704-283-7359

    Awawu Igbinadolor

    Recruiting

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557

    252-222-5700

    Kathryn Lucas

    Recruiting

  • Quality Medical Research

    Nashville, Tennessee, 37211

    615-835-4750

    Saras Sharma

    Recruiting

  • Knownwell

    Needham, Massachusetts, 02492

    339-793-8998

    Angela Fitch

    Recruiting

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740

    508-720-2015

    David Shih

    Recruiting

  • Lucas Research, Inc.

    New Bern, North Carolina, 28562

    252-649-1944

    Joseph Maides

    Recruiting

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

    727-849-4131

    Cathy Barnes

    Recruiting

  • Charter Research - Winter Park

    Orlando, Florida, 32803

    407-337-3000

    Edgardo Rivera-Rivera

    Recruiting

  • HOPE Research Institute

    Phoenix, Arizona, 85032

    Completed

  • North Suffolk Neurology

    Port Jefferson Station, New York, 11776

    Completed

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

    585-288-0890

    Patrick Connors

    Recruiting

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

    310-265-1623

    LeighAnn Schmidt

    Recruiting

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240

    518-428-6859

    Nitendra Agarwal

    Recruiting

  • Tekton Research - Fredericksburg Road

    San Antonio, Texas, 78258

    Completed

  • Headlands Research - Scottsdale

    Scottsdale, Arizona, 85260

    480-725-8708

    Benjamin Clark

    Recruiting

  • NorthShore University Health System

    Skokie, Illinois, 60077

    Completed

  • Headlands Research - Detroit

    Southfield, Michigan, 48034

    Christopher Romero

    Recruiting

  • Clinvest Headlands Llc

    Springfield, Missouri, 65807

    Christina Capps

    Recruiting

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

    David Radin

    Recruiting

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

    352-441-2000

    Jeffrey Norton

    Recruiting

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

    785-354-9591

    susan brian

    Recruiting

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

    248-312-0025

    Neil Fraser

    Recruiting

  • The Institute for Liver Health II dba Arizona Liver Health-Tucson

    Tucson, Arizona, 85712

    480-470-4000

    Anita Kohli

    Recruiting

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

    925-930-7267

    Bonnie Kimmel

    Recruiting

  • Central Washington Health Services Association d/b/a Confluence Health

    Wenatchee, Washington, 98801

    509-436-4050

    Kathryn Eren

    Recruiting

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596

    956-431-8090

    Eduardo Luna

    Recruiting

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266

    515-329-6800

    Anuj Bhargava

    Recruiting

Other trials in United States

Argentina7 sites, 7 recruiting

  • Cicemo Srl

    Buenos Aires, 1424

    5491157417654

    Pablo Costanzo

    Recruiting

  • CARDIAMET Investigaciones Médicas

    Buenos Aires, C1014ACP

    5491165496764

    Angela Romero Zarante

    Not yet recruiting

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

    08003450697

    Federico Perez Manghi

    Recruiting

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC

    54 1149635650

    Diego Aizenberg

    Recruiting

  • Mautalen Salud e Investigación

    Buenos Aires, C1128AAF

    541145143400

    Jose Fretes

    Not yet recruiting

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC

    5401148019001

    Evelyn Blanc

    Recruiting

  • Instituto Médico Catamarca IMEC

    Rosario, 2000

    3416176661

    Natacha Maldonado

    Not yet recruiting

Other trials in Argentina

About this study

Official title: 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.

Conditions
Obesity, Overweight
Being tested
LY3305677, LY3841136, Tirzepatide, LY3549492, LY3532226
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LY3305677Drug

    Administered SC. ISA specific interventions will be listed in the ISA.

  • LY3841136Drug

    Also called Eloralintide

    Administered SC. ISA specific interventions will be listed in the ISA.

  • TirzepatideDrug

    Also called LY3298176

    Administered SC. ISA specific interventions will be listed in the ISA.

  • LY3549492Drug

    Administered orally. ISA specific interventions will be listed in the ISA.

  • LY3532226Drug

    Also called Macupatide

    Administered SC. ISA specific interventions will be listed in the ISA.

  • PlaceboDrug

    Administered SC. ISA specific interventions will be listed in the ISA.

  • PlaceboDrug

    Administered orally. ISA specific interventions will be listed in the ISA.

Study groups in NCT06143956
Study groupRoleWhat they receive
LY3305677 Obesity ISA OXA1ExperimentalParticipants will receive LY3305677 or placebo subcutaneously (SC). Each ISA will detail the intervention specific analysis.
Receives: Drug: LY3305677; Drug: Placebo
LY3841136 Obesity ISA LAA1ExperimentalParticipants will receive LY3841136 or placebo SC. Each ISA will detail the intervention specific analysis.
Receives: Drug: LY3841136; Drug: Placebo
LY3841136 Obesity ISA LAA2ExperimentalParticipants will receive LY3841136, tirzepatide and placebo SC. Each ISA will detail the intervention specific analysis.
Receives: Drug: LY3841136; Drug: Tirzepatide; Drug: Placebo
LY3549492 Obesity ISA GN01ExperimentalParticipants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
Receives: Drug: LY3549492; Drug: Placebo
LY3549492 Obesity ISA GN02ExperimentalParticipants will receive LY3549492 or placebo orally. Each ISA will detail the intervention specific analysis.
Receives: Drug: LY3549492; Drug: Placebo
Obesity ISA MC01ExperimentalParticipants will receive macupatide, eloralintide, and placebo SC. Each ISA will detail the intervention specific analysis.
Receives: Drug: LY3841136; Drug: LY3532226; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Allocated to Each ISA

    Each ISA will detail the intervention specific analysis.

    Measured: Baseline to Week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2023
  2. Study start17 Nov 2023
  3. Primary completionSep 2027 (estimated)
  4. Study completionFeb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
The CWMM protocol includes screening assessments plus a framework for the subsequent intervention, which is the primary purpose of the protocol.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,481 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06143956
Sponsor's protocol ID
18685
Other IDs
W8M-MC-CWMM, W8M-MC-OXA1, W8M-MC-LAA1, W8M-MC-LAA2, W8M-MC-GN01, W8M-MC-GN02, W8M-MC-MC01
Status last verified
Oct 2026
First submitted
6 Nov 2023
Last updated
7 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LY3305677, LY3841136 and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 57 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 57 sites in United States, Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Allocated to Each ISA (time frame: Baseline to Week 6). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06143956.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.

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