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Recruiting NCT07152002

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

Phase I Interventional Overweight or Obesity Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: LY4064912, LY4064912, Placebo, Placebo.
Who it may be relevant to
Registry conditions: Overweight or Obesity, Healthy. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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.

Interventions

  • Drug LY4064912
    Administered SC
  • Drug LY4064912
    Administered IV
  • Drug Placebo
    Administered SC
  • Drug Placebo
    Administered IV

Primary outcome measures

  • 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]
Secondary outcome measures (4)
  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4064912 [Time frame: Predose Up to Day 78]
  • PK: Maximum Concentration (Cmax) of LY4064912 [Time frame: Predose Up to Day 78]
  • Change from Baseline in Body Weight [Time frame: Baseline to Approximately Week 27]
  • Effects of LY4064912 on Renal Hemodynamics and Renal Function [Time frame: Baseline Up to Day 31]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Basic science

Study locations

United States · 2 centers
  • Collaborative Neuroscience Network - CNS — Los Alamitos
  • ICON Early Phase Services — San Antonio
Singapore · 1 center
  • Lilly Centre for Clinical Pharmacology — Singapore

Identifiers

NCT: NCT07152002 · 27192 · J5L-MC-YHAA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗