A Study to Investigate the Effect of LY4086940 Versus Placebo in Participants With Obesity or Overweight and Without Type 2 Diabetes
A Phase 2, Parallel-Group, Double-Blind Study to Investigate Weight Management With LY4086940 Compared With Placebo in Adult Participants With Obesity or Overweight and Without Type 2 Diabetes
2 other identifiers
interventional
460
2 countries
46
Brief Summary
The purpose of this study, performed under the master protocol W8M-MC- CWMM (NCT06143956), is to evaluate the efficacy and safety of LY4086940 compared with placebo in participants without type 2 diabetes who have obesity or who have overweight with a weight-related health condition. Participation in the study will last about 58 weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Nov 2026
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 16, 2026
CompletedFirst Posted
Study publicly available on registry
October 22, 2026
CompletedStudy Start
First participant enrolled
November 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
Study Completion
Last participant's last visit for all outcomes
June 1, 2028
October 22, 2026
October 1, 2026
1.2 years
October 16, 2026
October 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change from Baseline in Body Weight
Baseline, Week 32
Secondary Outcomes (4)
Percent Change from Baseline in Body Weight
Baseline, Week 48
Change from Baseline Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)
Baseline, Week 32, Week 48
Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4086940 for One Dosing Interval at Steady State
Week 48
PK: Maximum Concentration (Cmax) of LY4086940 at Steady State
Week 48
Study Arms (10)
LY4086940 Dose 1
EXPERIMENTALParticipants will receive LY4086940 orally
LY4086940 Dose 2
EXPERIMENTALParticipants will receive LY4086940 orally
LY4086940 Dose 3, Titration Schedule A
EXPERIMENTALParticipants will receive LY4086940 orally
LY4086940 Dose 3, Titration Schedule B
EXPERIMENTALParticipants will receive LY4086940 orally
LY4086940 Dose 4
EXPERIMENTALParticipants will receive LY4086940 orally
LY4086940 Dose 5
EXPERIMENTALParticipants will receive LY4086940 orally
LY4086940 Dose 6, Titration Schedule A
EXPERIMENTALParticipants will receive LY4086940 orally
LY4086940 Dose 6, Titration Schedule B
EXPERIMENTALParticipants will receive LY4086940 orally
LY4086940 Dose 6, Titration Schedule C
EXPERIMENTALParticipants will receive LY4086940 orally
Placebo
PLACEBO COMPARATORParticipants will receive placebo orally
Interventions
Administered orally
Eligibility Criteria
You may not qualify if:
- Have any prior diagnosis of type 2 diabetes, type 1 diabetes, or rare forms of diabetes mellitus, except gestational diabetes
- Have a laboratory value suggestive of diabetes
- Have any of the following cardiovascular conditions within 6 months prior to screening:
- acute myocardial infarction
- cerebrovascular accident (stroke)
- unstable angina, or
- hospitalization due to congestive heart failure
- Have a known personal or family history (first-degree relative) of multiple endocrine neoplasia type 2A or 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
- Within 6 months prior to screening, have taken medications (prescribed or over the counter) or alternative remedies (including herbal or nutritional supplements) that promote weight loss
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
Chandler, Arizona, 85225, United States
Headlands Research - Scottsdale
Scottsdale, Arizona, 85260, United States
The Institute for Liver Health II dba Arizona Liver Health-Tucson
Tucson, Arizona, 85712, United States
NorCal Medical Research, Inc
Greenbrae, California, 94904, United States
Velocity Clinical Research, Huntington Park
Huntington Park, California, 90255, United States
Peninsula Research Associates
Rolling Hills Estates, California, 90274, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Stamford Therapeutics Consortium
Stamford, Connecticut, 06905, United States
New Horizon Research Center
Miami, Florida, 33165, United States
Indago Research & Health Center, Inc
Miami Lakes, Florida, 33016, United States
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652, United States
Charter Research - Winter Park
Orlando, Florida, 32803, United States
Charter Research - Lady Lake
The Villages, Florida, 32162, United States
Medical Research Partners
Ammon, Idaho, 83406, United States
Great Lakes Clinical Trials - Ravenswood
Chicago, Illinois, 60640, United States
Iowa Diabetes and Endocrinology Research Center
West Des Moines, Iowa, 50266, United States
Cotton O'Neil Diabetes & Endocrinology
Topeka, Kansas, 66606, United States
Knownwell
Needham, Massachusetts, 02492, United States
Lucida Clinical Trials
New Bedford, Massachusetts, 02740, United States
Headlands Research - Detroit
Southfield, Michigan, 48034, United States
Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
Troy, Michigan, 48098, United States
StudyMetrix Research
City of Saint Peters, Missouri, 63303, United States
Clinvest Headlands Llc
Springfield, Missouri, 65807, United States
Las Vegas Medical Research
Las Vegas, Nevada, 89128, United States
Dent Neurologic Institute
Amherst, New York, 14226, United States
Rochester Clinical Research, LLC
Rochester, New York, 14609, United States
Monroe Biomedical Research
Monroe, North Carolina, 28112, United States
Lucas Research, Inc
Morehead City, North Carolina, 28557, United States
Lucas Research, Inc.
New Bern, North Carolina, 28562, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607, United States
Quality Medical Research
Nashville, Tennessee, 37211, United States
IMA Clinical Research Austin
Austin, Texas, 78745, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
FutureSearch Trials of Dallas
Dallas, Texas, 75251, United States
Endeavor Clinical Trials
San Antonio, Texas, 78240, United States
Texas Valley Clinical Research
Weslaco, Texas, 78596, United States
Sovah Clinical Research-River District
Danville, Virginia, 24541, United States
Central Washington Health Services Association d/b/a Confluence Health
Wenatchee, Washington, 98801, United States
Cicemo Srl
Buenos Aires, 1424, Argentina
CARDIAMET Investigaciones Médicas
Buenos Aires, C1014ACP, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1056ABI, Argentina
Centro Médico Viamonte
Buenos Aires, C1120AAC, Argentina
Mautalen Salud e Investigación
Buenos Aires, C1128AAF, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425AGC, Argentina
Instituto Médico Catamarca IMEC
Rosario, 2000, Argentina
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 M Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 16, 2026
First Posted
October 22, 2026
Study Start (Estimated)
November 1, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
June 1, 2028
Last Updated
October 22, 2026
Record last verified: 2026-10
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal should be approved by an independent review panel and researchers should sign a data sharing agreement.
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.