HealthyPhase 1NCT04049123

A Study of LY900014 in Healthy Chinese Participants

A Phase 1 study testing LY900014 and Insulin Lispro in people with Healthy, run by Eli Lilly and Company at 1 site in China.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate a new formulation of insulin lispro, LY900014, which is a drug that lowers blood sugar. The study will look at how the body processes LY900014 and the effect of LY900014 on blood sugar levels. For each participant, the study will consist of 3 periods and will last about 51 days. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY900014 and Insulin Lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteChina
Study dates: 18 Nov 2019to 23 Oct 2020
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 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Are overtly healthy native Chinese males or females
Female participants:
Women of child-bearing potential who are abstinent or use effective methods of contraception for the entirety of the study.
Women not of child-bearing potential who are infertile or post-menopausal
Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)
Are nonsmokers
Have a fasting plasma glucose value >71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L)

Who cannot join

Are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product
Have previously completed or withdrawn from this study or any other study investigating LY900014
Have known allergies to LY900014 or any components of the formulation
Have a significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, prior to dosing or during the study.
Have donated blood of more than 400 milliliters (mL) within the previous 6 months of study screening or donated more than 100 mL within the last 30 days.
Have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females)

Trial locations and contacts

1 site in 1 country.

China1 site

West China Hospital Sichuan University
Chengdu, Cn-51, 610041

Other trials in China

About this study

Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects

Conditions: Healthy
Being tested: LY900014, Insulin Lispro

What participants receive

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

LY900014Drug
Also called Ultra-Rapid Lispro
Administered SC
Insulin LisproDrug
Also called LY275585, Humalog
Administered SC

Study groups in NCT04049123
Study group	Role	What they receive
Insulin Lispro (Humalog)	Active comparator	15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods. Receives: Drug: Insulin Lispro
LY900014	Experimental	7 U, and 15 U LY900014 administered once, SC, in two of three study periods. Receives: Drug: LY900014

What is being measured

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

Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
PK: Insulin Lispro AUC(0-10h)
Measured: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose

Secondary outcomes (1)

Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
Gtot is the total amount of glucose infused over the duration of the clamp procedure (10 hours) for each study period.
Measured: Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose

Timeline

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

18 Nov 201923 Oct 2020

First posted7 Aug 2019
Study start18 Nov 2019
Primary completion23 Oct 2020
Study completion23 Oct 2020

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 HealthyStudies 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: Single blind
Who is masked: Participant
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04049123
Sponsor's protocol ID: 16644
Other IDs: I8B-MC-ITRY
Status last verified: Oct 2021
First submitted: 6 Aug 2019
Last updated: 16 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: 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

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Evaluate the Pharmacokinetics and Glucodynamics of LY900014 Following Single Dose Administration in Healthy Chinese Subjects
ClinicalTrials.gov ID: NCT04049123
Acronym / sponsor ID: 16644
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 18 Nov 2019 (actual)
Primary completion: 23 Oct 2020 (actual)
Study completion: 23 Oct 2020 (actual)
First posted: 7 Aug 2019 (actual)
Results: Posted 16 Nov 2021

Clinical summary

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Insulin Lispro (Humalog)	Active comparator	Drug: Insulin Lispro15 units (U) Insulin Lispro (Humalog) administered once, subcutaneously (SC), in one of three study periods.
LY900014	Experimental	Drug: LY9000147 U, and 15 U LY900014 administered once, SC, in two of three study periods.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Are overtly healthy native Chinese males or females
Female participants:
Have a body mass index (BMI) of 18 to 28 kilograms per square meter (kg/m²)
Are nonsmokers
Have a fasting plasma glucose value >71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter [mmol/L]) and <108 mg/dL (6.0 mmol/L)

Key exclusion criteria (7 listed)

Are currently enrolled in a clinical study, or have participated, within the last 30 days, in a clinical study involving an investigational product
Have previously completed or withdrawn from this study or any other study investigating LY900014
Have known allergies to LY900014 or any components of the formulation
Have a significant history of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
Intend to use over-the-counter or prescription medication within 7 and 14 days, respectively, prior to dosing or during the study.

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
LY900014Also: Ultra-Rapid LisproAdministered SC	Drug	LY900014
Insulin LisproAlso: LY275585, HumalogAdministered SC	Drug	Insulin Lispro (Humalog)

Primary outcome

Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])
Time frame: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose
PK: Insulin Lispro AUC(0-10h)

1 secondary outcome

Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot)
Time frame: Day 1: Predose: -10, -20, -30 minutes; During clamp: every 2.5 to 3 minutes for the first 30 minutes; every 5 minutes for 30 to 120 minutes; every 10 minutes for 120 to 480 minutes and every 20 minutes for 480 to 600 minutes postdose

Results and safety

Results posted to the registry on 16 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: CAB	5	5
Sequence 2: ACB	5	5
Sequence 3: ABC	5	5

Primary outcome: Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h])

Time frame: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose. Geometric mean (Geometric Coefficient of Variation). Unit: picomole * hour per Liter (pmol*h/L)

Measure	7 U LY900014 n = 15	15 U LY900014 n = 15	15 U Humalog n = 15
Value	708 (12)	1580 (11)	1600 (12)

Population analysed: All participants who received at least one dose of study drug and have evaluable PK data.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to end of study (up to 183 days).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
7 Unit (U) LY900014	0 of 15 (0%)	1 of 15 (6.7%)	0 of 15
15 U LY900014	0 of 15 (0%)	4 of 15 (26.7%)	0 of 15
15 U Humalog	0 of 15 (0%)	0 of 15 (0%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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 LY900014 and Insulin Lispro in people with Healthy, run by Eli Lilly and Company at 1 site in China.

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 7 inclusion and 7 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 16 Nov 2021. 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 China. 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 16 Nov 2021). 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?

Pharmacokinetics (PK): Insulin Lispro Area Under the Serum Concentration Versus Time Curve From Time Zero to 10 Hours Postdose (AUC[0-10h]) (time frame: Day 1: Predose, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 70, 90, 120, 150, 180, 240, 300, 360, 420, 480, 540, and 600 minutes postdose). 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 NCT04049123.

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 16 Nov 2021.