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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06945419

Enrollment

219

Registered

2025-04-25

Start date

2025-04-23

Completion date

2026-08-05

Last updated

2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Obesity, Overweight, Type 2 Diabetes

Keywords

Oral, Incretin, Weight loss, Overweight, Obesity, Diabetes

Brief summary

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.

Interventions

DRUGLY4086940

Administered orally

DRUGPlacebo

Administered orally

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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	Baseline up to Week 9

Secondary

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

Countries

Singapore, United States

Contacts

STUDY_DIRECTORCall 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026