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Active, Not Recruiting

NCT Number: NCT06945419

A 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Healthy Body Weight Body Weight Changes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type 2 Diabetes Weight Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology, Singapore

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY4086940

Drug

Administered orally

Placebo

Drug

Administered orally

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

    Time frame: Baseline up to Week 9

Secondary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4086940

    Time frame: Predose up to Day 64

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY4086940

    Time frame: Predose up to Day 64

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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