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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

Locations
United States
California
Collaborative Neuroscience Network - CNS
NOT_YET_RECRUITING
Los Alamitos
Texas
ICON Early Phase Services
RECRUITING
San Antonio
Other Locations
Singapore
Lilly Centre for Clinical Pharmacology
NOT_YET_RECRUITING
Singapore
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2025-08-28
Estimated Completion Date: 2026-10
Participants
Target number of participants: 144
Treatments
Experimental: Part A: LY4064912 (Cohorts 1-6)
LY4064912 administered subcutaneously (SC)
Experimental: Part A: LY4064912 (Cohort 4b)
LY4064912 administered intravenously (IV)
Placebo_comparator: Part A: Placebo
Placebo administered SC and IV
Experimental: Part B: LY4064912 (Cohorts 7-10)
LY4064912 administered SC
Placebo_comparator: Part B: Placebo
Placebo administered SC
Experimental: Part C: LY4064912 (Cohort 11)
LY4064912 administered SC
Experimental: Part C: Placebo
Placebo administered SC
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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