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

NCT07152002 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: 27192J5L-MC-YHAA
• Study Type: interventional
• Target: 144
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Overweight or Obesity; Healthy

Outcome Measures

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

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

  Postdose to Approximately Week 27

Secondary Outcomes (4)

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

  Predose Up to Day 78

• PK: Maximum Concentration (Cmax) of LY4064912

  Predose Up to Day 78

• Change from Baseline in Body Weight

  Baseline to Approximately Week 27

• Effects of LY4064912 on Renal Hemodynamics and Renal Function

  Baseline Up to Day 31

Study Arms (7)

Part A: LY4064912 (Cohorts 1-6)

EXPERIMENTAL

LY4064912 administered subcutaneously (SC)

Drug: LY4064912

Part A: LY4064912 (Cohort 6a)

EXPERIMENTAL

LY4064912 administered intravenously (IV)

Drug: LY4064912

Part A: Placebo

PLACEBO COMPARATOR

Placebo administered SC and IV

Drug: Placebo

Part B: LY4064912 (Cohorts 7-10)

EXPERIMENTAL

LY4064912 administered SC

Drug: LY4064912

Part B: Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Part C: LY4064912 (Cohort 11)

EXPERIMENTAL

LY4064912 administered SC

Drug: LY4064912

Part C: Placebo

EXPERIMENTAL

Placebo administered SC

Drug: Placebo

Interventions

LY4064912 DRUG

Administered SC

Part A: LY4064912 (Cohorts 1-6); Part B: LY4064912 (Cohorts 7-10); Part C: LY4064912 (Cohort 11)

Placebo DRUG

Administered SC

Part A: Placebo; Part B: Placebo; Part C: Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Collaborative Neuroscience Network - CNS

Los Alamitos, California, 90720, United States

RECRUITING

ICON Early Phase Services

San Antonio, Texas, 78209, United States

RECRUITING

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

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: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 3, 2025
• Study Start: August 28, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1); US (2)