Current partner codePEPTIDESDE
NCT03841630·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

45

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

LY3437943

Administered subcutaneously (SC)

DRUG

Placebo

Administered SC

Timeline

From registration to results.

  1. First posted

    Feb 15, 2019

  2. Study start

    Mar 13, 2019

  3. Primary completion

    Jul 25, 2019

  4. Study completion

    Jul 25, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Aug 6, 2019

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline through final follow-up at approximately Day 43

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

Secondary outcomes

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

Time frame · Baseline through final follow-up at approximately Day 43

Pharmacokinetics: AUC(0-inf) of LY3437943

Pharmacokinetics: Maximum Concentration (Cmax) of LY3437943

Time frame · Baseline through final follow-up at approximately Day 43

Pharmacokinetics: Cmax of LY3437943

Pharmacokinetics: Time to Maximum Concentration (Tmax) of LY3437943

Time frame · Baseline through final follow-up at approximately Day 43

Pharmacokinetics: Tmax of LY3437943

Eligibility

Who can take part.

Minimum age
21 Years
Maximum age
65 Years
Sex
ALL
Healthy volunteers
Yes

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Study locations

1 registered sites.

Singapore. Showing up to 24 locations stored in the fast local snapshot.

Lilly Centre for Clinical Pharmacology

Singapore, Singapore

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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Put the record in context.

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