A Safety Study of LY3437943 Given as a Single Injection in Healthy Participants

NCT03841630 | Completed Phase 1

• 2 other identifiers: 17136J1I-MC-GZBA
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to determine the side effects related to LY3437943 given as a single injection under the skin to healthy participants. Blood tests will be performed to check how much LY3437943 gets into the bloodstream and how long the body takes to get rid of it. Each enrolled participant will receive a single dose of LY3437943 or placebo. The study will last up to approximately 71 days for each participant, including screening.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

  Baseline through final follow-up at approximately Day 43

Secondary Outcomes (3)

• Pharmacokinetics: Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of LY3437943

  Baseline through final follow-up at approximately Day 43

• Pharmacokinetics: Maximum Concentration (Cmax) of LY3437943

  Baseline through final follow-up at approximately Day 43

• Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943

  Baseline through final follow-up at approximately Day 43

Study Arms (2)

LY3437943

EXPERIMENTAL

Escalating doses of LY3437943 administered as an injection under the skin in healthy participants

Drug: LY3437943

Placebo

PLACEBO COMPARATOR

Matching placebo administered as an injection under the skin in healthy participants

Drug: Placebo

Interventions

LY3437943 DRUG

Administered subcutaneously (SC)

LY3437943

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overtly healthy male or a female who cannot get pregnant
• Have a body mass index (BMI) between 19 and 40 kilograms per square meter (kg/m²), inclusive, at screening
• Have normal blood pressure, pulse rate, electrocardiogram (ECG, heart tracing), blood and urine laboratory test results that are acceptable for the study
• Have veins suitable for ease of blood sampling

You may not qualify if:

• Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
• Have previously completed or withdrawn from this study
• Smoke more than the equivalent of 10 cigarettes per day and are unwilling to stop smoking during the inpatient stay in the study
• Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
• Have been treated with weight loss medications within 3 months of screening

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Centre for Clinical Pharmacology

Singapore, 138623, Singapore

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: March 13, 2019
• Primary Completion: July 25, 2019
• Study Completion: July 25, 2019
• Last Updated: August 6, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)