Healthy VolunteersPhase 1NCT02293551

A Study of Lispro Formulations in Healthy Participants

A Phase 1 study testing Lispro in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Singapore.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 1 siteSingapore
Study dates: Dec 2014to Sep 2015
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Singapore1 site

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

Other trials in Singapore

About this study

Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations

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
Being tested: Lispro

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LisproDrug
Also called LY275585
Administered SC

Study groups in NCT02293551
Study group	Role	What they receive
Part A: Lispro (A)	Experimental	Formulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods. Receives: Drug: Lispro
Part A: Lispro (B)	Experimental	Formulation B: Single dose of lispro administered SC in one of five periods. Receives: Drug: Lispro
Part A: Lispro (C)	Experimental	Formulation C: Single dose of lispro administered SC in one of five periods. Receives: Drug: Lispro
Part A: Lispro (D)	Experimental	Formulation D: Single dose of lispro administered SC in one of five periods. Receives: Drug: Lispro
Part A: Lispro (Reference)	Experimental	Reference formulation: Single dose of lispro administered SC in one of five periods. Receives: Drug: Lispro
Part B: Lispro	Experimental	Formulation selected from Part A. Single dose of lispro administered SC in one of four periods. Receives: Drug: Lispro

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2014Sep 2015

First posted18 Nov 2014 (estimated)
Study startDec 2014
Primary completionSep 2015
Study completionSep 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02293551
Sponsor's protocol ID: 15626
Other IDs: F3Z-FW-ITCA
Status last verified: Sep 2025
First submitted: 13 Nov 2014
Last updated: 8 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Pharmacokinetics of Multiple Novel Insulin Lispro Formulations
ClinicalTrials.gov ID: NCT02293551
Acronym / sponsor ID: 15626
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Dec 2014
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 18 Nov 2014 (estimated)
Results: Posted 8 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 6

Arm	Type	Receives
Part A: Lispro (A)	Experimental	Drug: LisproFormulation A: Single dose of lispro administered subcutaneously (SC) in one of five periods.
Part A: Lispro (B)	Experimental	Drug: LisproFormulation B: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (C)	Experimental	Drug: LisproFormulation C: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (D)	Experimental	Drug: LisproFormulation D: Single dose of lispro administered SC in one of five periods.
Part A: Lispro (Reference)	Experimental	Drug: LisproReference formulation: Single dose of lispro administered SC in one of five periods.
Part B: Lispro	Experimental	Drug: LisproFormulation selected from Part A. Single dose of lispro administered SC in one of four periods.

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LisproAlso: LY275585Administered SC	Drug	Part A: Lispro (A), Part A: Lispro (B), Part A: Lispro (C), Part A: Lispro (D), Part A: Lispro (Reference), Part B: Lispro

Primary outcome

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.

Results and safety

Results posted to the registry on 8 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part A: Lispro Sequence 1	8	8
Part A: Lispro Sequence 2	8	8
Part A: Lispro Sequence 3	8	8
Part B: Lispro Sequence 1	10	10
Part B Lispro Sequence 2	10	10
Part B Lispro Sequence 3	10	10

Primary outcome: 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. Geometric mean (Geometric Coefficient of Variation). Unit: picomole*hour/Liter (pmol*hr/L)

Measure	Part A: Lispro (7.0 U - Reference) n = 24	Part A: Lispro (7.28 U - Test A) n = 24	Part A: Lispro (7.28 U - Test B) n = 24	Part A: Lispro (7.28 U - Test C) n = 24	Part A: Lispro (7.28 U - Test D) n = 24	Part B: Lispro (7.28 U - Test B) n = 28	Part B: Lispro (15.47 U - Test B) n = 28	Part B: Lispro (30.03 U - Test B) n = 29
Value	916 (21)	957 (22)	1020 (22)	972 (21)	971 (23)	864 (17)	2000 (20)	3990 (14)

Part A: Lispro (7.0 U - Reference) vs Part A: Lispro (7.28 U - Test A): Geometric Ratio of Least Squares Mean: 1.04 (90% CI 0.988 to 1.10), p = 0.2071, Log Rank
Part A: Lispro (7.0 U - Reference) vs Part A: Lispro (7.28 U - Test B): Geometric Ratio of Least Square Means: 1.11 (90% CI 1.06 to 1.17), p = 0.0005, Log Rank
Part A: Lispro (7.0 U - Reference) vs Part A: Lispro (7.28 U - Test C): Geometric of Ratio Least Square Means: 1.08 (90% CI 1.03 to 1.13), p = 0.0123, Log Rank

Population analysed: All randomized participants who were completers and had evaluable PK data.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A: Lispro (7.0 U - Reference)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Part A: Lispro (7.28 U - Test A)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Part A: Lispro (7.28 U - Test B)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Part A: Lispro (7.28 U - Test C)	0 of 24 (0%)	4 of 24 (16.7%)	Not reported
Part A: Lispro (7.28 U - Test D)	0 of 24 (0%)	2 of 24 (8.3%)	Not reported
Part B: Lispro (7.28 U - Test B)	0 of 28 (0%)	6 of 28 (21.4%)	Not reported
Part B: Lispro (15.47 U - Test B)	0 of 28 (0%)	3 of 28 (10.7%)	Not reported
Part B: Lispro (30.03 U - Test B)	0 of 29 (0%)	7 of 29 (24.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy Volunteers

RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Lispro in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02293551.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.