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A Study of LY3437943 in Healthy Participants With a High Body Mass Index

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05959096
Collaborator
(none)
64
Enrollment
1
Location
2
Arms
10
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
64 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
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
Anticipated Study Start Date :
Jul 18, 2023
Anticipated Primary Completion Date :
Feb 7, 2024
Anticipated Study Completion Date :
May 16, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY3437943 (Part A)

LY3437943 administered subcutaneously (SC) in either thigh, upper arm, or abdomen

Drug: LY3437943
Administered SC
Experimental: LY3437943 (Part B)

LY3437943 administered intravenously (IV)

Drug: LY3437943
Administered IV

Outcome Measures

Primary Outcome Measures

  1. Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943 [Predose on Day 1 up to 43 days postdose (Part A)]

    Part A: PK: AUC(0-∞) of LY3437943

  2. Part A: PK: Maximum Concentration (Cmax) of LY3437943 [Predose on Day 1 up to 43 days postdose (Part A)]

    Part A: PK: Cmax of LY3437943

Secondary Outcome Measures

  1. Part B: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943 [Predose on Day 1 up to 71 days postdose (Part B)]

    Part B: PK: AUC(0-∞) of LY3437943

  2. Part B: PK: Maximum Concentration (Cmax) of LY3437943 [Predose on Day 1 up to 71 days postdose (Part B)]

    Part B: PK: Cmax of LY3437943

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 LabCorp CRU, Inc Daytona Beach Florida United States 32117

Sponsors and Collaborators

  • Eli Lilly and Company

Investigators

  • Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT05959096
Other Study ID Numbers:
  • 18532
  • J1I-MC-GZBS
First Posted:
Jul 25, 2023
Last Update Posted:
Jul 25, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 25, 2023