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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
Date last updated
1/10/2024

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
The study is conducted in two parts (Part A and B). The main purpose of this study is to look at the amount of the LY3437943 that gets into the blood stream and how long it takes the body to get rid of it when given subcutaneously (SC, under the skin) in the upper arm and thigh compared to the abdomen in healthy participants with high body mass index (BMI) in Part A. In Part B, the participants receive LY3437943 intravenously (IV, through a vein) where the safety and tolerability of LY3437943 are evaluated and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately up to 157 days and 99 days for Part A and Part B, respectively.
Trial website
https://clinicaltrials.gov/study/NCT05959096
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05959096