HealthyPhase 1NCT02342314

A Study of LY3143753 and LY3185643 in Healthy Participants

A Phase 1 study testing LY3143753 (Part A), LY3185643 (Part B) and rGlucagon (Part B) in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.

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

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3143753 (Part A), LY3185643 (Part B) and rGlucagon (Part B)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 68 participants
Where: 1 siteUnited Kingdom
Study dates: Jan 2015to Sep 2016
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Overtly healthy males or females
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Who cannot join

Are investigator site personnel directly affiliated with this study and their immediate families
Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
Have participated, within the last 3 months, in a clinical trial
Have known or ongoing psychiatric disorders
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody

Show all 9Show fewer

Show evidence of hepatitis B and/or positive hepatitis B surface antigen
History of/current phaeochromocytoma
History of/current insulinoma

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leeds, LS2 9LH

Other trials in United Kingdom

About this study

Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3143753 and LY3185643 in Healthy Subjects

The study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.

Conditions: Healthy
Being tested: LY3143753 (Part A), LY3185643 (Part B), Placebo (Part A and Part B), rGlucagon (Part B)

What participants receive

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

LY3143753 (Part A)Drug
Administered via SC injection
LY3185643 (Part B)Drug
Administered via SC injection
Placebo (Part A and Part B)Drug
Administered via SC injection
rGlucagon (Part B)Drug
Administered via SC injection

Study groups in NCT02342314
Study group	Role	What they receive
LY3143753 (Part A)	Experimental	Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1 Receives: Drug: LY3143753 (Part A)
LY3185643 (Part B)	Experimental	Single SC injection of ascending doses of LY3185643 on Day 1 Receives: Drug: LY3185643 (Part B)
Placebo (Part A)	Placebo comparator	Single SC injection of normal saline on Day 1 Receives: Drug: Placebo (Part A and Part B)
rGlucagon (Part B)	Active comparator	Single SC injection on Day 1 Receives: Drug: rGlucagon (Part B)
Placebo (Part B)	Placebo comparator	Single SC injection of normal saline on Day 1 Receives: Drug: Placebo (Part A and Part B)

What is being measured

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

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Measured: Baseline to Study Completion (Up to 84 Days)

Secondary outcomes (14)

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Cmax of Part B
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: AUC(0-∞) of Part B
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Time to Maximum Drug Concentration (Tmax) of Part A
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Tmax of Part B
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD Absolute Maximum Blood Glucose of Part B
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Maximum Glucose Increase (Gmax) of Part A
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Gmax of Part B
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Time to Maximum Blood Glucose (Gtmax) of Part A
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Gtmax of Part B
Measured: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A
Measured: Baseline, 8 hours after drug administration
QTcF Change From Baseline of Part B
Measured: Baseline, 8 hours after drug administration

Timeline

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

Jan 2015Sep 2016

First posted19 Jan 2015 (estimated)
Study startJan 2015
Primary completionSep 2016
Study completionSep 2016

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: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 68 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02342314
Sponsor's protocol ID: 15503
Other IDs: I7U-MC-GAHA
Status last verified: Mar 2019
First submitted: 14 Jan 2015
Last updated: 13 Mar 2019
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?

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3143753 and LY3185643 in Healthy Subjects
ClinicalTrials.gov ID: NCT02342314
Acronym / sponsor ID: 15503
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 68 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 19 Jan 2015 (estimated)
Results: Posted 13 Mar 2019

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: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
LY3143753 (Part A)	Experimental	Drug: LY3143753 (Part A)Single subcutaneous (SC) injection of ascending doses of LY3143753 on Day 1
LY3185643 (Part B)	Experimental	Drug: LY3185643 (Part B)Single SC injection of ascending doses of LY3185643 on Day 1
Placebo (Part A)	Placebo comparator	Drug: Placebo (Part A and Part B)Single SC injection of normal saline on Day 1
rGlucagon (Part B)	Active comparator	Drug: rGlucagon (Part B)Single SC injection on Day 1
Placebo (Part B)	Placebo comparator	Drug: Placebo (Part A and Part B)Single SC injection of normal saline on Day 1

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Overtly healthy males or females
Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures

Key exclusion criteria (9 listed)

Are investigator site personnel directly affiliated with this study and their immediate families
Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
Have participated, within the last 3 months, in a clinical trial
Have known or ongoing psychiatric disorders
Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

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
LY3143753 (Part A)Administered via SC injection	Drug	LY3143753 (Part A)
LY3185643 (Part B)Administered via SC injection	Drug	LY3185643 (Part B)
Placebo (Part A and Part B)Administered via SC injection	Drug	Placebo (Part A), Placebo (Part B)
rGlucagon (Part B)Administered via SC injection	Drug	rGlucagon (Part B)

Primary outcome

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 to Study Completion (Up to 84 Days)
A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

14 secondary outcomes

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Cmax of Part B
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: AUC(0-∞) of Part B
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Time to Maximum Drug Concentration (Tmax) of Part A
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
PK: Tmax of Part B
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4, 6, 8 Hours
Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD Absolute Maximum Blood Glucose of Part B
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Maximum Glucose Increase (Gmax) of Part A
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Gmax of Part B
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Time to Maximum Blood Glucose (Gtmax) of Part A
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
PD: Gtmax of Part B
Time frame: Predose, 5,10, 15, 20, 25, 30, 35, 40, 45, 50, 550, 60, 70, 80, 90, 105, minutes and 2, 2.5, 3, 4 Hours
QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A
Time frame: Baseline, 8 hours after drug administration
QTcF Change From Baseline of Part B
Time frame: Baseline, 8 hours after drug administration

Results and safety

Results posted to the registry on 13 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo (Part A)	6	6
0.05 mg of LY3143753 (Part A)	3	3
0.1 mg of LY3143753 (Part A)	3	3
0.2 mg of LY3143753 (Part A)	3	3
0.4 mg of LY3143753 (Part A)	6	6
1.0 mg of LY3143753 (Part A)	3	3
Placebo (Part B)	0	0
0.01 mg of LY3185643 (Part B)	0	0
0.03 mg of LY3185643 (Part B)	0	0
0.05 mg of LY3185643 (Part B)	0	0
0.06 mg of LY3185643 (Part B)	0	0
0.1 mg of LY3185643 (Part B)	0	0
0.2 mg of LY3185643 (Part B)	0	0
0.3 mg of LY3185643 (Part B)	0	0
0.48 mg of LY3185643 (Part B)	0	0
0.72 mg of LY3185643 (Part B)	0	0
rGlucagon (Part B)	0	0

Primary outcome: 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 to Study Completion (Up to 84 Days). Count of participants. Unit: Participants

Measure	Placebo (Part A) n = 6	0.05 mg of LY3143753 (Part A) n = 3	0.1 mg of LY3143753 (Part A) n = 3	0.2 mg of LY3143753 (Part A) n = 3	0.4 mg of LY3143753 (Part A) n = 6	1 mg of LY3143753 (Part A) n = 3	Placebo (Part B) n = 11	0.01 mg of LY3185643 (Part B) n = 3	0.03 mg of LY3185643 (Part B) n = 3	0.05 mg of LY3185643 (Part B) n = 3	0.06 mg of LY3185643 (Part B) n = 3	0.1 mg of LY3185643 (Part B) n = 3	0.2 mg of LY3185643 (Part B) n = 3	0.3 mg of LY3185643 (Part B) n = 3	Part B 0.48 mg of LY3185643 n = 3	0.72 mg of LY3185643 (Part B) n = 3	r Glucagon (Part B) n = 6
Value	0	0	0	0	1	1	1	0	0	0	0	0	0	0	0	0	0

Population analysed: All randomized participants who received at least one dose of study drug.

14 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Part A)	0 of 6 (0%)	5 of 6 (83.3%)	Not reported
0.05 mg of LY3143753 (Part A)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
0.1 mg of LY3143753 (Part A)	0 of 3 (0%)	3 of 3 (100%)	Not reported
0.2 mg of LY3143753 (Part A)	0 of 3 (0%)	3 of 3 (100%)	Not reported
0.4 mg of LY3143753 (Part A)	1 of 6 (16.7%)	4 of 6 (66.7%)	Not reported
1 mg of LY3143753 (Part A)	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
Placebo (Part B)	1 of 11 (9.1%)	5 of 11 (45.5%)	Not reported
0.01 mg of LY3185643 (Part B)	0 of 3 (0%)	3 of 3 (100%)	Not reported
0.03 mg of LY3185643 (Part B)	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
0.05 mg of LY3185643 (Part B)	0 of 3 (0%)	1 of 3 (33.3%)	Not reported
0.06 mg of LY3185643 (Part B)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
0.1 mg of LY3185643 (Part B)	0 of 3 (0%)	3 of 3 (100%)	Not reported
0.2 mg of LY3185643 (Part B)	0 of 3 (0%)	3 of 3 (100%)	Not reported
0.3 mg of LY3185643 (Part B)	0 of 3 (0%)	2 of 3 (66.7%)	Not reported
Part B 0.48 mg of LY3185643	0 of 3 (0%)	3 of 3 (100%)	Not reported
0.72 mg of LY3185643 (Part B)	0 of 3 (0%)	3 of 3 (100%)	Not reported
r Glucagon (Part B)	0 of 6 (0%)	2 of 6 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 LY3143753 (Part A), LY3185643 (Part B) and rGlucagon (Part B) in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.

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 2 inclusion and 9 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 13 Mar 2019. 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 United Kingdom. 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. Some participants in this study may receive a placebo. 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 13 Mar 2019). 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?

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 to Study Completion (Up to 84 Days)). 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 NCT02342314.

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 13 Mar 2019.