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

NCT06945419 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27267J5U-MC-YGAA
• Study Type: interventional
• Target: 216
• Locations: 2 countries
• Sites: 5

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.

Conditions

Healthy; Overweight; Obesity; Type 2 Diabetes

Keywords

Oral; Incretin; Weight loss; Overweight; Obesity; Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

Study Arms (11)

Part A: LY4086940 Single Dose (Healthy Participants)

EXPERIMENTAL

Participants will receive a single dose of LY4086940 orally

Drug: LY4086940

Part A: Placebo Single Dose (Healthy Participants)

PLACEBO COMPARATOR

Participants will receive a single dose of placebo orally

Drug: Placebo

Part A: LY4086940 Multiple Dose (Healthy Participants)

EXPERIMENTAL

Participants will receive LY4086940 orally for 3 days

Drug: LY4086940

Part A: Placebo Multiple Dose (Healthy Participants)

PLACEBO COMPARATOR

Participants will receive placebo orally for 3 days

Drug: Placebo

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

EXPERIMENTAL

Participants will receive LY4086940 orally for 4 weeks

Drug: LY4086940

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

PLACEBO COMPARATOR

Participants will receive placebo orally for 4 weeks

Drug: Placebo

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

EXPERIMENTAL

Participants will receive LY4086940 orally for 4 weeks

Drug: LY4086940

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

PLACEBO COMPARATOR

Participants will receive placebo orally for 4 weeks

Drug: Placebo

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

EXPERIMENTAL

Participants will receive LY4086940 orally for 4-6 weeks

Drug: LY4086940

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

PLACEBO COMPARATOR

Participants will receive placebo orally for 4-6 weeks

Drug: Placebo

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

EXPERIMENTAL

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

Drug: LY4086940

Interventions

Placebo DRUG

Administered orally

Part A: Placebo Multiple Dose (Healthy Participants); Part A: Placebo Single Dose (Healthy Participants); Part B: Placebo Multiple Dose (Participants with Overweight or Obesity); Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity; Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)

LY4086940 DRUG

Administered orally

Part A: LY4086940 Multiple Dose (Healthy Participants); Part A: LY4086940 Single Dose (Healthy Participants); Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity); Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity); Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

COMPLETED

Clinical Pharmacology of Miami

Miami, Florida, 33172, United States

RECRUITING

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

COMPLETED

Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

ACTIVE NOT RECRUITING

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

COMPLETED

Related Links

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

MeSH Terms

Conditions

Overweight; Obesity; Diabetes Mellitus, Type 2; Weight Loss; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Body Weight Changes

Study Officials

• 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

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

CONTACT

clinical_inquiry_hub@lilly.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 25, 2025
• Study Start: April 23, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); US (4)