A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes

August 18, 2026 updated by: Eli Lilly and Company

A Single-Dose and Multiple-Ascending Dose Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes

The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.

Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 10 visits. Participation in Part E will last approximately 7 weeks and may include up to 12 visits.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

219

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • Singapore
      • Singapore, Singapore, 138623
        • Lilly Centre for Clinical Pharmacology
  • United States
    • Florida
      • Daytona Beach, Florida, United States, 32117
        • Fortrea Clinical Research Unit
      • Miami, Florida, United States, 33172
        • Clinical Pharmacology of Miami
    • Texas
      • Dallas, Texas, United States, 75247
        • Fortrea Clinical Research Unit
      • San Antonio, Texas, United States, 78240
        • Endeavor Clinical Trials

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

Yes

Description

Inclusion Criteria:

  • Have no significant body weight change for the 3 months prior to screening

Part A and Part E:

  • Are considered healthy
  • Have a body mass index (BMI) of 22 to 35 kilograms per square meter (kg/m2) at screening

Part B:

  • Have a BMI of 27 to 45 kg/m2 at screening

Part C:

  • Have a BMI of 25 to 45 kg/m2 at screening

Part D:

  • Have type 2 diabetes
  • Have hemoglobin A1C (HbA1c) ≥6.5% and ≤10.5% at screening
  • Have a BMI of 27 to 45 kg/m2 at screening

Exclusion Criteria:

  • Have had an acute cardiovascular condition within the past 6 months prior to screening
  • Have liver disease or pancreatitis
  • Have used medications for weight loss within the 3 months prior to screening

Parts A, B, C, E:

  • Have any form of diabetes

Part D:

  • Have type 1 diabetes

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: LY4086940 Single Dose (Healthy Participants)
Participants will receive a single dose of LY4086940 orally
Drug: LY4086940
Administered orally
Drug: LY4086940
Administered IV
Placebo Comparator: Part A: Placebo Single Dose (Healthy Participants)
Participants will receive a single dose of placebo orally
Drug: Placebo
Administered orally
Experimental: Part A: LY4086940 Multiple Dose (Healthy Participants)
Participants will receive LY4086940 orally for 3 days
Drug: LY4086940
Administered orally
Drug: LY4086940
Administered IV
Placebo Comparator: Part A: Placebo Multiple Dose (Healthy Participants)
Participants will receive placebo orally for 3 days
Drug: Placebo
Administered orally
Experimental: Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity)
Participants will receive LY4086940 orally for 4 weeks
Drug: LY4086940
Administered orally
Drug: LY4086940
Administered IV
Placebo Comparator: Part B: Placebo Multiple Dose (Participants with Overweight or Obesity)
Participants will receive placebo orally for 4 weeks
Drug: Placebo
Administered orally
Experimental: Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity)
Participants will receive LY4086940 orally for 4 weeks
Drug: LY4086940
Administered orally
Drug: LY4086940
Administered IV
Placebo Comparator: Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity
Participants will receive placebo orally for 4 weeks
Drug: Placebo
Administered orally
Experimental: Part E (Open-Label): LY4086940 Single Dose (Healthy Participants)
Participants will receive a single dose of LY4086940 intravenously (IV)
Drug: LY4086940
Administered orally
Drug: LY4086940
Administered IV
Experimental: Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
Participants will receive LY4086940 orally for 4-6 weeks
Drug: LY4086940
Administered orally
Drug: LY4086940
Administered IV
Placebo Comparator: Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)
Participants will receive placebo orally for 4-6 weeks
Drug: Placebo
Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Time Frame: Baseline up to Week 9
Baseline up to Week 9

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4086940
Time Frame: Predose up to Day 64
Predose up to Day 64
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4086940
Time Frame: Predose up to Day 64
Predose up to Day 64

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

April 23, 2025

Primary Completion (Actual)

August 5, 2026

Study Completion (Actual)

August 5, 2026

Study Registration Dates

First Submitted

April 18, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 18, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27267
  • J5U-MC-YGAA (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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