A Study of Lispro Formulations in Healthy Participants

The purposes of this study are to determine:

* Part A

* How quickly your body absorbs, breaks down and gets rid of the different formulations of insulin lispro compared to insulin lispro alone formulation. * The safety of insulin lispro in different formulations and any side effects that might be associated with it. * Part B:

* How much insulin lispro from different dose ranges is found in the bloodstream using a test insulin lispro formulation (selected from Part A). * The safety of insulin lispro in different formulations and any side effects that might be associated with it.

Participants may only enroll in one part. The study is expected to last up to 10 weeks for each part.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.

Singapore

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Overtly healthy males or females (non-childbearing potential and with absent cyclical hormonal changes), as determined by medical history and physical examination

Exclusion criteria

Have a fasting plasma glucose less than or equal to (≤) 4.0 millimole per liter (mmol/L) at screening

Treatment and study plan

Lispro

Drug

Administered SC

Other names: LY275585

Primary outcomes

Part A and Part B: Pharmacokinetics (PK): Area Under The Concentration Curve Zero to Infinity (AUC[0-∞])

Time frame: -30, 0 (Predose), 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150,180, 240, and 300 Minutes

Primary outcome measure is based on the PK area under the concentration curve from 0 to infinity with a measurable concentration.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2015
First posted: Nov 18, 2014
Registry last updated: Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed