RecruitingRecruiting
A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes
NCT06945419 · Eli Lilly and Company
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 216 participants
Allocation: randomized
Masking: double
Age groups: adult, older_adult
Timeline
Starts: 2025-04-23
Estimated completion: 2026-07
Last updated: 2026-05-12
Interventions
Drug: LY4086940Drug: PlaceboDrug: LY4086940
Primary outcomes
- • 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)
Sponsor
Eli Lilly and Company · industry
Contacts & investigators
ContactTrial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or · contact · LillyTrials@Lilly.com · 1-317-615-4559
ContactPhysicians interested in becoming principal investigators please contact · contact · clinical_inquiry_hub@lilly.com
InvestigatorCall 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) · study_director, Eli Lilly and Company
All locations (5)
Fortrea Clinical Research UnitCompleted
Daytona Beach, Florida, United States
Clinical Pharmacology of MiamiRecruiting
Miami, Florida, United States
Fortrea Clinical Research UnitCompleted
Dallas, Texas, United States
Endeavor Clinical TrialsActive Not Recruiting
San Antonio, Texas, United States
Lilly Centre for Clinical PharmacologyCompleted
Singapore, Singapore