HealthyPhase 1NCT02951780

A Study of LY3185643 and rGlucagon in Healthy Participants

A Phase 1 study testing LY3185643 and rGlucagon in people with Healthy, 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.

Official record

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Trial summary

The purpose of this study is to determine how the body handles LY3185643 and rGlucagon and what effects LY3185643 and rGlucagon have on the body. This study will also help to determine if LY3185643 is safe and well-tolerated. This study will last at least 35 days, not including screening. Read more about this study

Who is it for?: Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: LY3185643 and rGlucagon
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteSingapore
Study dates: 1 Nov 2016to 1 Mar 2017
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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are overtly healthy as determined by medical history and physical examination
Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)

Who cannot join

Have participated, within the last 30 days, in a clinical trial involving an investigational product
Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the formulation
History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the 12-lead ECG
Abnormal blood pressure
History of recurring symptomatic postural hypotension irrespective of the decrease in blood pressure, or asymptomatic postural hypotension at screening as defined as a decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of Mercury (mm Hg) within 3 minutes when changing from supine to standing position
History of vasovagal response such as fainting

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History of or current 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
History of/current insulinoma and/or pheochromocytoma
Have used systemic glucocorticoids within 3 months before entry into the study

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: A Randomized, 9-Way, Single-Dose, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of LY3185643 and rGlucagon in Healthy Subjects

This study will last at least 35 days, not including screening.

Conditions: Healthy
Being tested: LY3185643, rGlucagon

What participants receive

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

LY3185643Drug
Administered SC
rGlucagonDrug
Administered SC

Study groups in NCT02951780
Study group	Role	What they receive
LY3185643	Experimental	LY3185643 administered subcutaneous (SC) Receives: Drug: LY3185643
rGlucagon	Experimental	rGlucagon administered subcutaneous (SC) Receives: Drug: rGlucagon

What is being measured

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

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon
Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.
Measured: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon
Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon.
Measured: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon
Cmax was assessed for LY3185643 and rGlucagon.
Measured: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon
Cmax was assessed for C-peptide of LY3185643 and rGlucagon
Measured: -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon
Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for LY3185643 and rGlucagon.
Measured: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon
Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for C-peptide of LY3185643 and rGlucagon.
Measured: -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose

Timeline

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

1 Nov 20161 Mar 2017

First posted1 Nov 2016 (estimated)
Study start1 Nov 2016
Primary completion24 Jan 2017
Study completion1 Mar 2017

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: Double blind
Who is masked: Participant, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02951780
Sponsor's protocol ID: 16502
Other IDs: I8Z-MC-APCA
Status last verified: Sep 2019
First submitted: 31 Oct 2016
Last updated: 30 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, 9-Way, Single-Dose, Crossover Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of LY3185643 and rGlucagon in Healthy Subjects
ClinicalTrials.gov ID: NCT02951780
Acronym / sponsor ID: 16502
Conditions: Healthy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 1 Nov 2016 (actual)
Primary completion: 24 Jan 2017 (actual)
Study completion: 1 Mar 2017 (actual)
First posted: 1 Nov 2016 (estimated)
Results: Posted 30 Sep 2019

Clinical summary

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

This study will last at least 35 days, not including screening.

Study design

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

Arm	Type	Receives
LY3185643	Experimental	Drug: LY3185643LY3185643 administered subcutaneous (SC)
rGlucagon	Experimental	Drug: rGlucagonrGlucagon administered subcutaneous (SC)

Who may qualify

Ages: 21 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Are overtly healthy as determined by medical history and physical examination
Body mass index of 18.0 to 30.0 kilograms per square meter (kg/m²)

Key exclusion criteria (9 listed)

Have participated, within the last 30 days, in a clinical trial involving an investigational product
Known allergies to LY3185643 or rGlucagon, related compounds, or any components of the formulation
History or electrocardiogram (ECG) evidence of heart block, or any abnormality in the 12-lead ECG
Abnormal blood pressure
History of recurring symptomatic postural hypotension irrespective of the decrease in blood pressure, or asymptomatic postural hypotension at screening as defined as a decrease in systolic blood pressure greater than or equal to (≥) 20 millimeter of Mercury (mm Hg) within 3 minutes when changing from supine to standing position

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
LY3185643Administered SC	Drug	LY3185643
rGlucagonAdministered SC	Drug	rGlucagon

Primary outcome

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon
Time frame: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
Maximum observed plasma concentration (Cmax) was assessed for LY3185643 and rGlucagon.
Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon
Time frame: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose
Area under the concentration versus time curve from zero to infinity (AUC0-inf) was assessed for LY3185643 and rGlucagon.
Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon
Time frame: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
Cmax was assessed for LY3185643 and rGlucagon.
Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon
Time frame: -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose
Cmax was assessed for C-peptide of LY3185643 and rGlucagon
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of Blood Glucose of LY3185643 and rGlucagon
Time frame: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose
Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for LY3185643 and rGlucagon.
Pharmacodynamics (PD): Change From Baseline in Area Under the Concentration Time Curve (AUC) of C-Peptide of LY3185643 and rGlucagon
Time frame: -5, 0 (pre-dose), 5, 15, 30, 60 and 120 minutes post-dose
Area under the concentration versus time curve from time zero to 3 hours [AUC (0-3)] was assessed for C-peptide of LY3185643 and rGlucagon.

Results and safety

Results posted to the registry on 30 Sep 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
Cohort A (Sequence 1-9-7: 6-4-8: 5-3-2)	3	3
Cohort B (Sequence 2,7,8: 4,5,9: 6,1,3 )	2	2
Cohort C (Sequence 3,8,9: 5,6,7: 4,2,1)	3	3
Cohort D (Sequence 4,6,2: 3,9,1: 8,7,5)	3	2
Cohort E (Sequence 5,4,3: 1,7,2: 9,8,6)	2	2
Cohort F (Sequence 6,5,1: 2,8,3: 7,9,4)	3	3
Cohort G (Sequence 7,1,4: 9,2,6: 9,2,6)	2	2
Cohort H (Sequence 8,2,5: 7,3,4: 1,6,9)	3	2
Cohort I (Sequence 9,3,6: 8,1,5: 2,4,7) )	2	2

Primary outcome: Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon

Time frame: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: picogram per milliliter (pg/mL)

Measure	10 ug LY3185643 n = 19	25 ug LY3185643 n = 22	50 ug LY3185643 n = 20	100 ug LY3185643 n = 21	200 ug LY3185643 n = 21	10 ug rGlucagon n = 19	25 ug rGlucagon n = 21	50 ug rGlucagon n = 22	200 ug rGlucagon n = 20
Value	191 (49)	658 (36)	1110 (40)	2010 (40)	3830 (38)	53.7 (31)	204 (70)	283 (44)	897 (49)

Population analysed: All randomized participants who received at least one dose of study drug (LY3185643, rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PK data.

Primary outcome: Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3185643 and rGlucagon

Time frame: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose. Geometric mean (Geometric Coefficient of Variation). Unit: picogram*hour per milliliter (pg*hr/mL)

Measure	10 ug LY3185643 n = 4	25 ug LY3185643 n = 20	50 ug LY3185643 n = 19	100 ug LY3185643 n = 18	200 ug LY3185643 n = 15	10 ug rGlucagon n = 19	25 ug rGlucagon n = 15	50 ug rGlucagon n = 20	200 ug rGlucagon n = 20
Value	356 (30)	1200 (21)	2230 (21)	4430 (21)	9120 (17)	NA (NA)	189 (57)	249 (24)	764 (26)

Primary outcome: Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of Blood Glucose of LY3185643 and rGlucagon

Time frame: -5, 0 (pre-dose), 5, 10, 15, 22, 30, 45, 60, 75, 90, 105, 120, 150, 180 minutes post-dose. Mean (Standard Deviation). Unit: milligram per deciliter (mg/dL)

Measure	10 ug LY3185643 n = 20	25 ug LY3185643 n = 23	50 ug LY3185643 n = 21	100 ug LY3185643 n = 22	200 ug LY3185643 n = 22	10 ug rGlucagon n = 21	25 ug rGlucagon n = 21	50 ug rGlucagon n = 22	200 ug rGlucagon n = 20
Value	5.54 (2.66)	15.1 (9.94)	24.0 (16.6)	37.1 (20.6)	53.2 (17.7)	4.37 (3.39)	12.5 (11.1)	16.9 (11.4)	38.1 (13.9)

Primary outcome: Pharmacodynamics (PD): Change From Baseline in Maximum Concentration (Cmax) of C-peptide of LY3185643 and rGlucagon

Time frame: -5, 0 (predose), 5, 15, 30, 60 and 120 minutes post-dose. Mean (Standard Deviation). Unit: picomole per liter (pmol/L)

Measure	10 ug LY3185643 n = 20	25 ug LY3185643 n = 23	50 ug LY3185643 n = 21	100 ug LY3185643 n = 22	200 ug LY3185643 n = 22	10 ug rGlucagon n = 21	25 ug rGlucagon n = 21	50 ug rGlucagon n = 22	200 ug rGlucagon n = 20
Value	50.2 (44.7)	201 (168)	324 (330)	555 (387)	969 (451)	25.4 (34.1)	119 (98.9)	218 (154)	577 (292)

Population analysed: All randomized participants who received at least one dose of study drug (C-peptide of LY3185643 and rGlucagon) and with a baseline and at least 1 postbaseline measurement for each dose with evaluable LY3185643 and rGlucagon PD data.

Adverse events

Time frame: Up To 3 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
10 ug LY3185643	0 of 20 (0%)	3 of 20 (15%)	0 of 20
25 ug LY3185643	0 of 23 (0%)	3 of 23 (13%)	0 of 23
50 ug LY3185643	0 of 21 (0%)	3 of 21 (14.3%)	0 of 21
100 ug LY3185643	0 of 22 (0%)	5 of 22 (22.7%)	0 of 22
200 ug LY3185643	0 of 22 (0%)	4 of 22 (18.2%)	0 of 22
10 ug rGlucagon	0 of 21 (0%)	2 of 21 (9.5%)	0 of 21
25 ug rGlucagon	0 of 21 (0%)	1 of 21 (4.8%)	0 of 21
50 ug rGlucagon	0 of 22 (0%)	2 of 22 (9.1%)	0 of 22
200 ug rGlucagon	0 of 20 (0%)	2 of 20 (10%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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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 LY3185643 and rGlucagon in people with Healthy, 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 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 30 Sep 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 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 30 Sep 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?

Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3185643 and rGlucagon (time frame: 0 (pre-dose), 15, 30, 60, 120 and 180 minutes post-dose). The study lists 6 primary outcomes in all. 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 NCT02951780.

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 30 Sep 2019.