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

NCT05959096 | Completed Phase 1 FDA Drug

• 2 other identifiers: 18532J1I-MC-GZBS
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Part A: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943

  Part A: PK: AUC(0-∞) of LY3437943

  Predose on Day 1 up to 43 days postdose (Part A)

• Part A: PK: Maximum Concentration (Cmax) of LY3437943

  Part A: PK: Cmax of LY3437943

  Predose on Day 1 up to 43 days postdose (Part A)

Secondary Outcomes (2)

• 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: Maximum Concentration (Cmax) of LY3437943

  Predose on Day 1 up to 71 days postdose (Part B)

Study Arms (2)

LY3437943 (Part A)

EXPERIMENTAL

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

Drug: LY3437943

LY3437943 (Part B)

EXPERIMENTAL

LY3437943 administered intravenously (IV)

Drug: LY3437943

Interventions

LY3437943 DRUG

Administered SC

LY3437943 (Part A)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

MeSH Terms

Interventions

retatrutide

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: July 18, 2023
• Primary Completion: July 25, 2024
• Study Completion: July 25, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)