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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05959096




Registration number
NCT05959096
Ethics application status
Date submitted
17/07/2023
Date registered
25/07/2023

Titles & IDs
Public title
A Study of LY3437943 in Healthy Participants With a High Body Mass Index
Scientific title
Effect of Injection Site on the Relative Bioavailability of a Single Dose of LY3437943 in Healthy Participants With a High Body Mass Index
Secondary ID [1] 0 0
J1I-MC-GZBS
Secondary ID [2] 0 0
18532
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - LY3437943
Treatment: Drugs - LY3437943

Experimental: LY3437943 (Part A) - LY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen

Experimental: LY3437943 (Part B) - LY3437943 administered intravenously (IV)


Treatment: Drugs: LY3437943
Administered SC

Treatment: Drugs: LY3437943
Administered IV
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3437943
Timepoint [1] 0 0
Predose on Day 1 up to 43 days postdose (Part A)
Primary outcome [2] 0 0
Part A: PK: Maximum Concentration (Cmax) of LY3437943
Timepoint [2] 0 0
Predose on Day 1 up to 43 days postdose (Part A)
Secondary outcome [1] 0 0
Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-8]) of LY3437943
Timepoint [1] 0 0
Predose on Day 1 up to 71 days postdose (Part B)
Secondary outcome [2] 0 0
Part B: PK: Maximum Concentration (Cmax) of LY3437943
Timepoint [2] 0 0
Predose on Day 1 up to 71 days postdose (Part B)

Eligibility
Key inclusion criteria
* Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
* Body mass index (BMI) between 27.0 and 45.0 kilograms per meter squared (kg/m²), inclusive
* Are agreeable to receiving study treatment by injections under the skin or through a vein.
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Have a history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form)
* Have a significant history of, or presence of, any of the following disorders capable of significantly altering the absorption, metabolism, or elimination of drugs
* Have known allergies to LY3437943, related compounds, or any components of the formulation
* Smoke more than 10 cigarettes or use the equivalent tobacco, smoking-cessation products, nicotine-containing products, or e cigarettes (nicotine and non nicotine) per day.
* Is a known user of drugs of abuse

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/07/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/07/2024
Sample size
Target
Accrual to date
Final
85
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Eli Lilly and Company
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Address 0 0
Eli Lilly and Company
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05959096