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ObesityPhase 2NCT06603571

A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

A Phase 2 study testing LY3841136 and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 52 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. 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?
LY3841136 and Tirzepatide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
367 participants
Where
52 sitesin 2 countries
Study dates
20 Sep 2024to 14 Sep 2026
Phase
Phase 2
Are there results?
None posted in the registry

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

  • W8M-MC-LAA2
  • Have a Body Mass Index (BMI) of ≥27 kilograms per square meter (kg/m²)
  • Have Type 2 Diabetes
  • Have a HbA1c ≥7.0 % (53 millimoles/mole (mmol/mol)) to ≤10.5% (91 mmol/mol) and treated with diet and exercise alone or with a stable dose of metformin (and not more than the locally approved dose) with or without a sodium-glucose cotransporter 2 (SGLT2) inhibitor for at least 3 months prior to screening
  • W8M-MC-CWMM:
  • Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)

Who cannot join

  • W8M-MC-LAA2
  • Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening
  • Have an on-going or history of bradyarrhythmia and/or sinus bradycardia
  • Have an elevated resting pulse rate (mean >100 beats per minute (bpm)) or reduced resting pulse rate (mean <60 bpm) at screening
  • Have any of the following cardiovascular conditions within 6 months prior to screening:
  • acute myocardial infarction
Show all 20Show fewer
  • cerebrovascular accident (stroke)
  • unstable angina, or
  • hospitalization due to congestive heart failure
  • Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliters per minute (mL/min)/1.73 m2
  • Have a history of acute or chronic pancreatitis
  • Have fasting triglycerides >500 milligrams per deciliter (mg/dL) (5.7 mmol/L) at screening
  • All concomitant medications should be at a stable dose for at least 3 months prior to screening
  • 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.

Trial locations and contacts

52 sites in 2 countries.

52 sites in 2 countries

United States48 sites

  • Dent Neurologic Institute

    Amherst, New York, 14226

  • Medical Research Partners

    Ammon, Idaho, 83406

  • IMA Clinical Research Austin

    Austin, Texas, 78745

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

    Chandler, Arizona, 85225

  • Great Lakes Clinical Trials - Andersonville

    Chicago, Illinois, 60640

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640

  • CTI Clinical Research Center

    Cincinnati, Ohio, 45212

  • StudyMetrix Research

    City of Saint Peters, Missouri, 63303

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • FutureSearch Trials of Dallas

    Dallas, Texas, 75251

  • Spectrum Medical, Inc.

    Danville, Virginia, 24541

  • Velocity Clinical Research, Syracuse

    East Syracuse, New York, 13057

  • Northeast Research Institute (NERI)

    Fleming Island, Florida, 32003

  • NorCal Medical Research, Inc

    Greenbrae, California, 94904

  • Medication Management

    Greensboro, North Carolina, 27405

  • Tribe Clinical Research, LLC

    Greenville, South Carolina, 29607

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • PlanIt Research, PLLC

    Houston, Texas, 77079

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89128

  • New Horizon Research Center

    Miami, Florida, 33165

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • Lucas Research, Inc

    Morehead City, North Carolina, 28557

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Knownwell

    Needham, Massachusetts, 02492

  • Lucida Clinical Trials

    New Bedford, Massachusetts, 02740

  • Lucas Research, Inc.

    New Bern, North Carolina, 28562

  • Suncoast Clinical Research, Inc.

    New Port Richey, Florida, 34652

  • Charter Research - Winter Park

    Orlando, Florida, 32803

  • HOPE Research Institute

    Phoenix, Arizona, 85032

  • North Suffolk Neurology

    Port Jefferson Station, New York, 11776

  • Rochester Clinical Research, LLC

    Rochester, New York, 14609

  • Peninsula Research Associates

    Rolling Hills Estates, California, 90274

  • Tekton Research - Fredericksburg Road

    San Antonio, Texas, 78229

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240

  • Headlands Research - Scottsdale

    Scottsdale, Arizona, 85260

  • NorthShore University Health System

    Skokie, Illinois, 60077

  • Headlands Research - Detroit

    Southfield, Michigan, 48034

  • Clinvest Headlands Llc

    Springfield, Missouri, 65807

  • Stamford Therapeutics Consortium

    Stamford, Connecticut, 06905

  • Charter Research - Lady Lake

    The Villages, Florida, 32162

  • Cotton O'Neil Diabetes & Endocrinology

    Topeka, Kansas, 66606

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division

    Troy, Michigan, 48098

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

    Tucson, Arizona, 85712

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598

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

    Wenatchee, Washington, 98801

  • Texas Valley Clinical Research

    Weslaco, Texas, 78596

  • Iowa Diabetes and Endocrinology Research Center

    West Des Moines, Iowa, 50266

Other trials in United States

Argentina4 sites

  • Centro de Investigaciones Metabólicas (CINME)

    Buenos Aires, C1056ABI

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC

  • Consultorio de Investigación Clínica EMO SRL

    Buenos Aires, C1405BUB

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    Buenos Aires, C1425AGC

Other trials in Argentina

About this study

Official title: A Phase 2, Parallel-Group, Double-Blind, Placebo-Controlled Study to Investigate Weight Management With LY3841136 and Tirzepatide, Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.

Conditions
Obesity, Overweight
Being tested
LY3841136, Tirzepatide, Placebo
Keywords
Type 2 Diabetes
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2

What participants receive

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

  • LY3841136Drug

    Administered SC

  • TirzepatideDrug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT06603571
Study groupRoleWhat they receive
LY3841136 Dose 1ExperimentalParticipants will receive LY3841136 subcutaneously (SC)
Receives: Drug: LY3841136
LY3841136 Dose 2ExperimentalParticipants will receive LY3841136 SC
Receives: Drug: LY3841136
LY3841136 Dose 3ExperimentalParticipants will receive LY3841136 SC
Receives: Drug: LY3841136
LY3841136 Dose 1 + Tirzepatide Dose 1ExperimentalParticipants will receive LY3841136 SC and Tirzepatide SC
Receives: Drug: LY3841136; Drug: Tirzepatide
LY3841136 Dose 2 + Tirzepatide Dose 1ExperimentalParticipants will receive LY3841136 SC and Tirzepatide SC
Receives: Drug: LY3841136; Drug: Tirzepatide
LY3841136 Dose 2 + Tirzepatide Dose 2ExperimentalParticipants will receive LY3841136 SC and Tirzepatide SC
Receives: Drug: LY3841136; Drug: Tirzepatide
LY3841136 Dose 3 + Tirzepatide Dose 3ExperimentalParticipants will receive LY3841136 SC and Tirzepatide SC
Receives: Drug: LY3841136; Drug: Tirzepatide
Tirzepatide Dose 3Active comparatorParticipants will receive Tirzepatide SC
Receives: Drug: Tirzepatide
LY3841136 Dose 2 + Tirzepatide Dose 3ExperimentalParticipants will receive LY3841136 SC and Tirzepatide SC
Receives: Drug: LY3841136; Drug: Tirzepatide
PlaceboPlacebo comparatorParticipants will receive placebo administered SC.
Receives: Drug: Placebo

What is being measured

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

  1. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 48

Secondary outcomes (6)

  1. Change from Baseline in Body Weight

    Measured: Baseline, Week 48

  2. Percentage of Participants Who Achieve ≥5% Body Weight Reduction

    Measured: Week 48

  3. Percentage of Participants Who Achieve ≥10% Body Weight Reduction

    Measured: Week 48

  4. Change from baseline in Hemoglobin A1c (HbA1c)

    Measured: Baseline, Week 48

  5. Pharmacokinetics (PK): Area Under the Curve (AUC) of LY3841136

    Measured: Baseline, Week 48

  6. PK: Maximum Concentration (Cmax) of LY3841136

    Measured: Baseline, Week 48

Timeline

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

  1. First posted19 Sep 2024
  2. Study start20 Sep 2024
  3. Primary completion1 Jul 2026
  4. Study completion14 Sep 2026

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
367 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06603571
Sponsor's protocol ID
18809
Other IDs
W8M-MC-LAA2, W8M-MC-CWMM Master Protocol
Status last verified
Sep 2026
First submitted
17 Sep 2024
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
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 LY3841136 and Tirzepatide in people with Obesity and Overweight, run by Eli Lilly and Company at 52 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 6 inclusion and 20 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: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Body Weight (time frame: Baseline, Week 48). 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 NCT06603571.

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 29 Sep 2026.

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