A Study of Lispro Formulations in Healthy Participants

NCT02293551 | Completed Phase 1 Results

• 2 other identifiers: 15626F3Z-FW-ITCA
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

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

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

Study Arms (6)

Part A: Lispro (A)

EXPERIMENTAL

Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.

Drug: Lispro

Part A: Lispro (B)

EXPERIMENTAL

Formulation B: Single dose of lispro administered SC in one of five periods.

Drug: Lispro

Part A: Lispro (C)

EXPERIMENTAL

Formulation C: Single dose of lispro administered SC in one of five periods.

Drug: Lispro

Part A: Lispro (D)

EXPERIMENTAL

Formulation D: Single dose of lispro administered SC in one of five periods.

Drug: Lispro

Part A: Lispro (Reference)

EXPERIMENTAL

Reference formulation: Single dose of lispro administered SC in one of five periods.

Drug: Lispro

Part B: Lispro

EXPERIMENTAL

Formulation selected from Part A. Single dose of lispro administered SC in one of four periods.

Drug: Lispro

Interventions

Lispro DRUG

Administered SC

Also known as: LY275585

Part A: Lispro (A); Part A: Lispro (B); Part A: Lispro (C); Part A: Lispro (D); Part A: Lispro (Reference); Part B: Lispro

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

You may not qualify if:

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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

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, Singapore

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Eli Lilly and Company
• Organization: Chief Medical Officer

800-545-5979

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

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2014
• First Posted: November 18, 2014
• Study Start: December 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 8, 2025
• Results First Posted: September 8, 2025

Record last verified: 2025-09

Locations

SG (1)