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NCT Number: NCT07152002

A Study of LY4064912 in Healthy Participants and With Overweight or Obesity

The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and participants with overweight and obesity - global. The study drug will be administered either subcutaneously (SC) (under the skin) or infusion intravenously (IV) (into a vein in the arm).

Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.

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Key information

Conditions

Overweight or Obesity Body Weight Healthy Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

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

  • Age is 21-65 years old at Singapore Sites
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring

Part A: Body Mass Index (BMI) within the range greater than or equal to 21 and less than 30 kilogram per square meter (kg/m²)

Part B: a BMI greater than or equal to 27 and less than 45 kg/m²

Part C: a BMI greater than or equal to 21 and less than 35 kg/m²

  • Parts A and C: Participants must weigh 60 kilograms (kg) or more at screening
  • Have had a less than 5% change in body weight for 3 months before screening
  • Safety laboratory tests are within normal reference range

Exclusion criteria

  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
  • Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have HbA1c greater than or equal to 6.5% (48 millimole per mole (mmol/mol)) at screening
  • Are individuals of childbearing potential (IOCBP).

Treatment and study plan

LY4064912

Drug

Administered SC

Placebo

Drug

Administered SC

Primary outcomes

  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Postdose to Approximately Week 27

    A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module

Secondary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4064912

    Time frame: Predose Up to Day 78

    PK: AUC of LY4064912

  2. PK: Maximum Concentration (Cmax) of LY4064912

    Time frame: Predose Up to Day 78

    PK: Cmax of LY4064912

  3. Change from Baseline in Body Weight

    Time frame: Baseline to Approximately Week 27

    Change from Baseline in Body Weight

  4. Effects of LY4064912 on Renal Hemodynamics and Renal Function

    Time frame: Baseline Up to Day 31

    Glomerular Filtration Rate (GFR)

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 1, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4064912 in Healthy Participants and Participants With Overweight or Obesity

Acronym: YHAA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2025
Registry last updated
Apr 20, 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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