MedDataX Logo

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

NCT ID: NCT06945419

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

201 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-23

Study Completion Date

2026-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 9 visits. Participation in Part E will last approximately 7 weeks and may include up to 12 visits.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Overweight Obesity Type 2 Diabetes

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Oral Incretin Weight loss Overweight Obesity Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Part A: LY4086940 Single Dose (Healthy Participants)

Participants will receive a single dose of LY4086940 orally

Group Type EXPERIMENTAL

LY4086940

Intervention Type DRUG

Administered orally

Part A: Placebo Single Dose (Healthy Participants)

Participants will receive a single dose of placebo orally

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Part A: LY4086940 Multiple Dose (Healthy Participants)

Participants will receive LY4086940 orally for 3 days

Group Type EXPERIMENTAL

LY4086940

Intervention Type DRUG

Administered orally

Part A: Placebo Multiple Dose (Healthy Participants)

Participants will receive placebo orally for 3 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity)

Participants will receive LY4086940 orally for 4 weeks

Group Type EXPERIMENTAL

LY4086940

Intervention Type DRUG

Administered orally

Part B: Placebo Multiple Dose (Participants with Overweight or Obesity)

Participants will receive placebo orally for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity)

Participants will receive LY4086940 orally for 4 weeks

Group Type EXPERIMENTAL

LY4086940

Intervention Type DRUG

Administered orally

Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity

Participants will receive placebo orally for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)

Participants will receive LY4086940 orally for 4 weeks

Group Type EXPERIMENTAL

LY4086940

Intervention Type DRUG

Administered orally

Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)

Participants will receive placebo orally for 4 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Part E (Open-Label): LY4086940 Single Dose (Healthy Participants)

Participants will receive a single dose of LY4086940 intravenously (IV)

Group Type EXPERIMENTAL

LY4086940

Intervention Type DRUG

Administered IV

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

LY4086940

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

LY4086940

Administered IV

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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) ≥7.0% 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Fortrea Clinical Research Unit

Daytona Beach, Florida, United States

Site Status RECRUITING

Fortrea Clinical Research Unit

Dallas, Texas, United States

Site Status RECRUITING

Endeavor Clinical Trials

San Antonio, Texas, United States

Site Status RECRUITING

Lilly Centre for Clinical Pharmacology

Singapore, , Singapore

Site Status COMPLETED

Countries

Review the countries where the study has at least one active or historical site.

United States Singapore

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

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

Role: CONTACT

Phone: 1-317-615-4559

Email: [email protected]

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Role: primary

Role: primary

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://trials.lilly.com/en-US/trial/599675

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

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

J5U-MC-YGAA

Identifier Type: OTHER

Identifier Source: secondary_id

27267

Identifier Type: -

Identifier Source: org_study_id