Healthy VolunteersPhase 1NCT01818245

A Study of LY2605541 in Healthy Participants and in the Elderly

A Phase 1 study testing LY2605541 in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

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

This study will include 2 groups (cohorts) of participants: In Cohort A, this study will look at the amount of LY2605541 that is present in the body after it is injected in 3 different locations in the body of the same participant. At least 16 days will pass between each injection. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: LY2605541
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteUnited States
Study dates: Mar 2013to Jul 2013
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

Cohort A: are overtly healthy male or female participants, as determined by medical history and physical examination, aged ≥18 to ≤55 years of age
Cohort B: are male or female elderly (≥65 years of age) participants that are overtly healthy, or have stable, chronic medical conditions (including Type 2 Diabetes Mellitus [T2DM]) that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data
Male participants agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product
Female participants are women of child-bearing potential who test negative for pregnancy at the time of screening based on a urine pregnancy test and agree to use a reliable method of birth control during the study and for 1 month following the last dose of the investigational product
Female participants are post-menopausal women, or women not of child-bearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, or at least 3 months after bilateral oophorectomy or bilateral tubal ligation/occlusion with or without hysterectomy) confirmed by medical history, or menopause
Have a body mass index (BMI) of 18.5 to 40 kilogram per meter square (kg/m^2), inclusive, at time of admission for Period 1
Have given written informed consent approved by Lilly and the ethical review board (ERB) governing the site

Who cannot join

Are participants that intend to start a change in diet or lose weight during the study; participants will be expected to maintain their approximate current weight throughout the study
Are excessive smokers (>10 cigarettes per day); participants who smoke ≤10 cigarettes per day must be able to stop smoking while residing at the clinical research unit (CRU)
Healthy Participants - Cohort A
Have Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM), or a fasting blood glucose (BG) >110 milligrams per deciliter (mg/dL) (6.1 millimoles per liter [mmol/L]) with a glycated hemoglobin (HbA1c) of >6.2%
Intend to use over-the-counter medication within the 7 days or prescription medication within 14 days prior to dosing (apart from contraceptive medication, vitamin/mineral supplements, occasional paracetamol, thyroxine replacement therapy, and hormone replacement therapy). Antihypertensive and lipid lowering agents are permitted, but must have been administered at stable dose(s) for at least 1 month.
Elderly Participants - Cohort B

Show all 9Show fewer

Have T1DM
Are T2DM participants that require insulin treatment, or have a HbA1c of >10%
Have started new chronic medication(s) or changed the dose of an existing chronic medication <1 month prior to dosing. Participants are permitted to continue ongoing chronic medications (for example antihypertensive agents, aspirin, non-steroidal anti-inflammatory drugs, lipid lowering agents, thyroxine, hormone replacement therapy, and/or oral anti-diabetic if participants have T2DM). Other stable chronic conditions may be permitted if deemed acceptable by the investigators and Lilly clinical pharmacologist or clinical research physician.

Trial locations and contacts

1 site in 1 country.

United States1 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.
Dallas, Texas

Other trials in United States

About this study

Official title: Effect of Injection Site on the Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of LY2605541 in Healthy Subjects, and Impact of Body Mass Index and Age on the Pharmacokinetics of LY2605541

This study will include 2 groups (cohorts) of participants:

In Cohort A, this study will look at the amount of LY2605541 that is present in the body after it is injected in 3 different locations in the body of the same participant. At least 16 days will pass between each injection.

In Cohort B, the study will look at how the body absorbs, distributes, and disposes of LY2605541 in participants aged 65 and over.

Participants may enroll in only one cohort.

Conditions: Healthy Volunteers
Being tested: LY2605541

What participants receive

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

LY2605541Drug

Study groups in NCT01818245
Study group	Role	What they receive
LY2605541: Cohort A (Injection site: Abdomen)	Experimental	Participants ≤55 years of age will receive 1 subcutaneous (SC) injection of 0.5 Units per kilogram (U/kg) of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. Receives: Drug: LY2605541
LY2605541: Cohort A (Injection site: Upper Arm)	Experimental	Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. Receives: Drug: LY2605541
LY2605541: Cohort A (Injection site: Thigh)	Experimental	Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period. Receives: Drug: LY2605541
LY2605541: Cohort B (Injection site: Abdomen)	Experimental	Participants ≥65 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1. Receives: Drug: LY2605541

What is being measured

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

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
AUC from time zero to infinity (AUC(0-∞)) of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).
Measured: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
Cmax of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).
Measured: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)
AUC(0-∞) for LY2605541 was evaluated.
Measured: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Pharmacokinetics: Maximum Plasma Concentration (Cmax): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)
Cmax of LY2605541 was evaluated.
Measured: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose

Secondary outcomes (2)

Pharmacodynamics: Total Amount of Glucose Infused (Gtot): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
Gtot was evaluated across injection sites (abdominal wall, arm, and thigh).
Measured: Predose up to 24 hours post clamp procedure in all treatment periods
Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
Rmax was evaluated across injection sites (abdominal wall, arm, and thigh).
Measured: Predose up to 24 hours post clamp procedure in all treatment periods

Timeline

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

Mar 2013Jul 2013

First posted26 Mar 2013 (estimated)
Study startMar 2013
Primary completionJul 2013
Study completionJul 2013

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: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01818245
Sponsor's protocol ID: 12152
Other IDs: I2R-MC-BIDF
Status last verified: Mar 2018
First submitted: 21 Mar 2013
Last updated: 16 Oct 2018
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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Study at a glance

From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Injection Site on the Pharmacokinetics and Pharmacodynamics of Single Subcutaneous Doses of LY2605541 in Healthy Subjects, and Impact of Body Mass Index and Age on the Pharmacokinetics of LY2605541
ClinicalTrials.gov ID: NCT01818245
Acronym / sponsor ID: 12152
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 26 Mar 2013 (estimated)
Results: Posted 16 Oct 2018

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 include 2 groups (cohorts) of participants:

In Cohort B, the study will look at how the body absorbs, distributes, and disposes of LY2605541 in participants aged 65 and over.

Participants may enroll in only one cohort.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
LY2605541: Cohort A (Injection site: Abdomen)	Experimental	Drug: LY2605541Participants ≤55 years of age will receive 1 subcutaneous (SC) injection of 0.5 Units per kilogram (U/kg) of LY2605541 in the abdominal wall on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period.
LY2605541: Cohort A (Injection site: Upper Arm)	Experimental	Drug: LY2605541Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the upper arm on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period.
LY2605541: Cohort A (Injection site: Thigh)	Experimental	Drug: LY2605541Participants ≤55 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the thigh on Day 1 in 1 of 3 treatment periods. There was a washout period of 16-28 days between each treatment period.
LY2605541: Cohort B (Injection site: Abdomen)	Experimental	Drug: LY2605541Participants ≥65 years of age will receive 1 SC injection of 0.5 U/kg of LY2605541 in the abdominal wall on Day 1.

Who may qualify

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

Key inclusion criteria (7 listed)

Cohort A: are overtly healthy male or female participants, as determined by medical history and physical examination, aged ≥18 to ≤55 years of age
Cohort B: are male or female elderly (≥65 years of age) participants that are overtly healthy, or have stable, chronic medical conditions (including Type 2 Diabetes Mellitus [T2DM]) that, in the investigator's opinion, will not significantly alter the disposition of the drug, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data
Male participants agree to use a reliable method of birth control during the study and for 3 months following the last dose of the investigational product
Female participants are women of child-bearing potential who test negative for pregnancy at the time of screening based on a urine pregnancy test and agree to use a reliable method of birth control during the study and for 1 month following the last dose of the investigational product
Female participants are post-menopausal women, or women not of child-bearing potential due to surgical sterilization (at least 3 months after surgical hysterectomy, or at least 3 months after bilateral oophorectomy or bilateral tubal ligation/occlusion with or without hysterectomy) confirmed by medical history, or menopause

Key exclusion criteria (9 listed)

Are participants that intend to start a change in diet or lose weight during the study; participants will be expected to maintain their approximate current weight throughout the study
Are excessive smokers (>10 cigarettes per day); participants who smoke ≤10 cigarettes per day must be able to stop smoking while residing at the clinical research unit (CRU)
Healthy Participants - Cohort A
Have Type 1 Diabetes Mellitus (T1DM), Type 2 Diabetes Mellitus (T2DM), or a fasting blood glucose (BG) >110 milligrams per deciliter (mg/dL) (6.1 millimoles per liter [mmol/L]) with a glycated hemoglobin (HbA1c) of >6.2%
Intend to use over-the-counter medication within the 7 days or prescription medication within 14 days prior to dosing (apart from contraceptive medication, vitamin/mineral supplements, occasional paracetamol, thyroxine replacement therapy, and hormone replacement therapy). Antihypertensive and lipid lowering agents are permitted, but must have been administered at stable dose(s) for at least 1 month.

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
LY2605541	Drug	LY2605541: Cohort A (Injection site: Abdomen), LY2605541: Cohort A (Injection site: Thigh), LY2605541: Cohort A (Injection site: Upper Arm), LY2605541: Cohort B (Injection site: Abdomen)

Primary outcome

Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
AUC from time zero to infinity (AUC(0-∞)) of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).
Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Cmax of LY2605541 was evaluated across injection sites (abdominal wall, arm, and thigh).
Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)
Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
AUC(0-∞) for LY2605541 was evaluated.
Pharmacokinetics: Maximum Plasma Concentration (Cmax): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)
Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose
Cmax of LY2605541 was evaluated.

2 secondary outcomes

Pharmacodynamics: Total Amount of Glucose Infused (Gtot): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
Time frame: Predose up to 24 hours post clamp procedure in all treatment periods
Pharmacodynamics: Maximum Glucose Infusion Rate (Rmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)
Time frame: Predose up to 24 hours post clamp procedure in all treatment periods

Results and safety

Results posted to the registry on 16 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LY2605541: Cohort A (Participants ≤55 Years of Age)	30	30
LY2605541: Cohort B (Participants ≥65 Years of Age)	22	22

Primary outcome: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)

Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles*hours/liter (pmol*h/L)

Measure	LY2605541: Cohort A (Injection Site: Abdomen) n = 30	LY2605541: Cohort A (Injection Site: Upper Arm) n = 30	LY2605541: Cohort A (Injection Site: Thigh) n = 30
Value	124000 (37)	133000 (39)	135000 (36)

Population analysed: Participants in Cohort A who received LY2605541 and had evaluable AUC(0-∞) data.

Primary outcome: Pharmacokinetics: Observed Maximum Plasma Concentration (Cmax): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A)

Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: picomoles/liter (pmol/L)

Measure	LY2605541: Cohort A (Injection Site: Abdomen) n = 30	LY2605541: Cohort A (Injection Site: Upper Arm) n = 30	LY2605541: Cohort A (Injection Site: Thigh) n = 30
Value	1839.17 (59)	1700.68 (54)	2027.99 (66)

Population analysed: Participants in Cohort A who received LY2605541 and had evaluable Cmax data.

Primary outcome: Pharmacokinetics: Area Under the Concentration-Time Curve (AUC): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)

Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: pmol*h/L

Measure	LY2605541: Cohort A (Injection Site: Abdomen) n = 30	LY2605541: Cohort B (Injection Site: Abdomen) n = 22
Value	124000 (37)	134000 (30)

Population analysed: Participants in Cohort A and B who received LY2605541 in the abdomen and had evaluable AUC(0-∞) data.

Primary outcome: Pharmacokinetics: Maximum Plasma Concentration (Cmax): Elderly Participants (≥65 Years of Age) Versus Participants ≤55 Years of Age (Abdominal Injection)

Time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose. Geometric mean (Geometric Coefficient of Variation). Unit: pmol/L

Measure	LY2605541: Cohort A (Injection Site: Abdomen) n = 30	LY2605541: Cohort B (Injection Site: Abdomen) n = 22
Value	1839.17 (59)	1829.92 (49)

Population analysed: Participants in Cohort A and B who received LY2605541 in the abdomen and had evaluable Cmax data.

2 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
LY2605541: Cohort A (Injection Site: Abdomen)	0 of 30 (0%)	3 of 30 (10%)	Not reported
LY2605541: Cohort A (Injection Site: Upper Arm)	0 of 30 (0%)	5 of 30 (16.7%)	Not reported
LY2605541: Cohort A (Injection Site: Thigh)	0 of 30 (0%)	13 of 30 (43.3%)	Not reported
LY2605541: Cohort B (Injection Site: Abdomen)	0 of 22 (0%)	7 of 22 (31.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
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 LY2605541 in people with Healthy Volunteers, run by Eli Lilly and Company at 1 site in United States.

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 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 16 Oct 2018. 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 States. 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 Oct 2018). 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: Area Under the Concentration-Time Curve (AUC): Injection Site (Arm and Thigh) Versus Abdominal Wall Injection (Cohort A) (time frame: Predose and 2, 4, 6, 8, 12, 24, 36, 48, 72, 120, 168, and 216 hours postdose). The study lists 4 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 NCT01818245.

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 Oct 2018.