Clinical trial NCT05959096: A Study of LY3437943 in Healthy Participants With a High Body Mass Index
Official title: Effect of Injection Site on the Relative Bioavailability of a Single Dose of LY3437943 in Healthy Participants With a High Body Mass Index
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-07-25
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

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

Primary outcomes:
measure: Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
timeFrame: Predose on Day 1 up to 43 days postdose (Part A)
measure: Part A: PK: Maximum Concentration (Cmax) of LY3437943
timeFrame: Predose on Day 1 up to 43 days postdose (Part A)
Secondary outcomes:
measure: Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
timeFrame: Predose on Day 1 up to 71 days postdose (Part B)
measure: Part B: PK: Maximum Concentration (Cmax) of LY3437943
timeFrame: Predose on Day 1 up to 71 days postdose (Part B)
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Fortrea Clinical Research Unit
state: Florida
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: