A Study of LY4064912 in Healthy Participants and With Overweight or Obesity
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
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
Disqualifiers
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).
Trial design
Design model
Sequential
Treatments tested in this trial
LY4064912
DrugAdministered SC
LY4064912
DrugAdministered IV
Placebo
DrugAdministered SC
Placebo
DrugAdministered IV
Treatment groups
144 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Group A: Part A: LY4064912 (Cohorts 1-6)Experimental treatment 1 intervention
Group B: Part A: LY4064912 (Cohort 6a)Experimental treatment 1 intervention
Group C: Part A: PlaceboPlacebo comparator 1 intervention
Group D: Part B: LY4064912 (Cohorts 7-10)Experimental treatment 1 intervention
Group E: Part B: PlaceboPlacebo comparator 1 intervention
Group F: Part C: LY4064912 (Cohort 11)Experimental treatment 1 intervention
Group G: Part C: PlaceboExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Postdose to Approximately Week 27Secondary outcomes
1
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4064912
PK: AUC of LY4064912
Time frame
Predose Up to Day 782
PK: Maximum Concentration (Cmax) of LY4064912
PK: Cmax of LY4064912
Time frame
Predose Up to Day 783
Change from Baseline in Body Weight
Change from Baseline in Body Weight
Time frame
Baseline to Approximately Week 274
Effects of LY4064912 on Renal Hemodynamics and Renal Function
Glomerular Filtration Rate (GFR)
Time frame
Baseline Up to Day 31Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov