ClinicalTrials.gg
Not yet recruitingNCT07890376Updated Oct 22, 2026

A Study to Investigate the Effect of LY4086940 Versus Placebo in Participants With Obesity or Overweight and Without Type 2 Diabetes

A Phase 2 interventional study of LY4086940 and Placebo in Obesity and Overweight, sponsored by Eli Lilly and Company. Not yet recruiting at 46 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-22.

Sponsored by Eli Lilly and Company · Phase 2, Interventional, and Treatment

Updated Oct 22, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
460
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Obesity
  • Overweight

Keywords

  • Incretins
  • Weight loss
  • Overnutrition
  • GLP-1
03

In context

Obesity

6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.

This study's planned enrollment of 460 is above the median of 77 across 5,084 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Meet inclusion criteria under Master Protocol CWMM (NCT06143956)

Exclusion criteria

Exclusion Criteria:

In addition to exclusion criteria under Master Protocol CWMM (NCT06143956)

  • 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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
460 participants (estimated)

Study arms

  • Experimental
    LY4086940 Dose 1

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Experimental
    LY4086940 Dose 2

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Experimental
    LY4086940 Dose 3, Titration Schedule A

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Experimental
    LY4086940 Dose 3, Titration Schedule B

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Experimental
    LY4086940 Dose 4

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Experimental
    LY4086940 Dose 5

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Experimental
    LY4086940 Dose 6, Titration Schedule A

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Experimental
    LY4086940 Dose 6, Titration Schedule B

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Experimental
    LY4086940 Dose 6, Titration Schedule C

    Participants will receive LY4086940 orally

    Drug: LY4086940

  • Placebo comparator
    Placebo

    Participants will receive placebo orally

    Drug: Placebo

Interventions

  • DrugLY4086940

    Administered orally

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 32

Secondary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 48

  2. Change from Baseline Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT)

    Time frame: Baseline, Week 32, Week 48

  3. Pharmacokinetics (PK): Area Under the Curve (AUC) of LY4086940 for One Dosing Interval at Steady State

    Time frame: Week 48

  4. PK: Maximum Concentration (Cmax) of LY4086940 at Steady State

    Time frame: Week 48

07

Study locations

46 sites
  • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
    Chandler, Arizona 85225, United States
    • Yessica Sachdeva · Principal investigator
  • Headlands Research - Scottsdale
    Scottsdale, Arizona 85260, United States
    • Benjamin Clark · Principal investigator
  • The Institute for Liver Health II dba Arizona Liver Health-Tucson
    Tucson, Arizona 85712, United States
    • Anita Kohli · Principal investigator
  • NorCal Medical Research, Inc
    Greenbrae, California 94904, United States
    • Linda Gaudiani · Principal investigator
  • Velocity Clinical Research, Huntington Park
    Huntington Park, California 90255, United States
    • Stanley Hsia · Principal investigator
  • Peninsula Research Associates
    Rolling Hills Estates, California 90274, United States
    • LeighAnn Schmidt · Principal investigator
  • Diablo Clinical Research, Inc.
    Walnut Creek, California 94598, United States
    • Bonnie Kimmel · Principal investigator
  • Stamford Therapeutics Consortium
    Stamford, Connecticut 06905, United States
    • David Radin · Principal investigator
  • New Horizon Research Center
    Miami, Florida 33165, United States
    • Lazaro Nunez · Principal investigator
  • Indago Research & Health Center, Inc
    Miami Lakes, Florida 33016, United States
    • Jose Cardona · Principal investigator
  • Suncoast Clinical Research, Inc.
    New Port Richey, Florida 34652, United States
    • Cathy Barnes · Principal investigator
  • Charter Research - Winter Park
    Orlando, Florida 32803, United States
    • Edgardo Rivera-Rivera · Principal investigator
  • Charter Research - Lady Lake
    The Villages, Florida 32162, United States
    • Jeffrey Norton · Principal investigator
  • Medical Research Partners
    Ammon, Idaho 83406, United States
    • Joseph Moore · Principal investigator
  • Great Lakes Clinical Trials - Ravenswood
    Chicago, Illinois 60640, United States
    • Rupal Trivedi · Principal investigator
  • Iowa Diabetes and Endocrinology Research Center
    West Des Moines, Iowa 50266, United States
    • Anuj Bhargava · Principal investigator
  • Cotton O'Neil Diabetes & Endocrinology
    Topeka, Kansas 66606, United States
    • susan brian · Principal investigator
  • Knownwell
    Needham, Massachusetts 02492, United States
    • Angela Fitch · Principal investigator
  • Lucida Clinical Trials
    New Bedford, Massachusetts 02740, United States
    • David Shih · Principal investigator
  • Headlands Research - Detroit
    Southfield, Michigan 48034, United States
    • Christopher Romero · Principal investigator
  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    Troy, Michigan 48098, United States
    • Neil Fraser · Principal investigator
  • StudyMetrix Research
    City of Saint Peters, Missouri 63303, United States
    • Timothy Smith · Principal investigator
  • Clinvest Headlands Llc
    Springfield, Missouri 65807, United States
    • Christina Capps · Principal investigator
  • Las Vegas Medical Research
    Las Vegas, Nevada 89128, United States
    • Cornell Calinescu · Principal investigator
  • Dent Neurologic Institute
    Amherst, New York 14226, United States
    • Laszlo Mechtler · Principal investigator
  • Rochester Clinical Research, LLC
    Rochester, New York 14609, United States
    • Patrick Connors · Principal investigator
  • Monroe Biomedical Research
    Monroe, North Carolina 28112, United States
    • Awawu Igbinadolor · Principal investigator
  • Lucas Research, Inc
    Morehead City, North Carolina 28557, United States
    • Kathryn Lucas · Principal investigator
  • Lucas Research, Inc.
    New Bern, North Carolina 28562, United States
    • Joseph Maides · Principal investigator
  • CTI Clinical Research Center
    Cincinnati, Ohio 45212, United States
    • James Maynard · Principal investigator
  • Tribe Clinical Research, LLC
    Greenville, South Carolina 29607, United States
    • Ronald Mayfield · Principal investigator
  • Quality Medical Research
    Nashville, Tennessee 37211, United States
    • Saras Sharma · Principal investigator
  • IMA Clinical Research Austin
    Austin, Texas 78745, United States
    • Nomita Kim · Principal investigator
  • Velocity Clinical Research, Dallas
    Dallas, Texas 75230, United States
    • Dan Lender · Principal investigator
  • FutureSearch Trials of Dallas
    Dallas, Texas 75251, United States
    • Michael Downing · Principal investigator
  • Endeavor Clinical Trials
    San Antonio, Texas 78240, United States
    • Nitendra Agarwal · Principal investigator
  • Texas Valley Clinical Research
    Weslaco, Texas 78596, United States
    • Eduardo Luna · Principal investigator
  • Sovah Clinical Research-River District
    Danville, Virginia 24541, United States
    • Stephan Jannach · Principal investigator
  • Central Washington Health Services Association d/b/a Confluence Health
    Wenatchee, Washington 98801, United States
    • Kathryn Eren · Principal investigator
  • Cicemo Srl
    Buenos Aires, 1424, Argentina
    • Pablo Costanzo · Principal investigator
  • CARDIAMET Investigaciones Médicas
    Buenos Aires, C1014ACP, Argentina
    • Angela Romero Zarante · Principal investigator
  • Centro de Investigaciones Metabólicas (CINME)
    Buenos Aires, C1056ABI, Argentina
    • Federico Perez Manghi · Principal investigator
  • Centro Médico Viamonte
    Buenos Aires, C1120AAC, Argentina
    • Diego Aizenberg · Principal investigator
  • Mautalen Salud e Investigación
    Buenos Aires, C1128AAF, Argentina
    • Jose Fretes · Principal investigator
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
    Buenos Aires, C1425AGC, Argentina
    • Evelyn Blanc · Principal investigator
  • Instituto Médico Catamarca IMEC
    Rosario, 2000, Argentina
    • Natacha Maldonado · Principal investigator
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Clinical study report

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.

Data sharing details ↗ · vivli.org

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jan 2028, 14 months later.

Of 141 industry-sponsored phase 2 interventional studies under Obesity, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 17. This study's planned 14 months is above that.

Counting every sponsor, half of 232 studies reached it within 15 months; a quarter within 9 and three quarters within 35.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 22, 2026
StartEst.
Nov 2026
Primary completionEst.
Jan 2028
CompletionEst.
Jun 2028
Last update
Oct 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 22, 2026
Show all 1 update
  1. Oct 22, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07890376
Responsible party
Sponsor
First posted
Oct 22, 2026
Start date
Nov 2026 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jun 2028 (estimated)
Last update
Oct 22, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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