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Diabetes Mellitus, Type 2Phase 1NCT01477567

A First-in-Human Study of LY3009385 in Healthy Participants

A Phase 1 study testing LY3009385 in people with Diabetes Mellitus, Type 2, 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 main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY3009385
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteSingapore
Study dates
Nov 2011to Mar 2012
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

  • Are a healthy male or a female who cannot become pregnant
  • Have a body mass index (BMI) of 18.5 to 32.0 kilograms per meter squared (kg/m^2) at screening
  • Have blood pressure, pulse rate, as well as blood and urine laboratory test results acceptable for the study
  • Have veins suitable for easy blood collection
  • Are reliable and willing to be available for the whole study and be willing to follow study procedures
  • Have given consent to participate in this study

Who cannot join

  • Are currently participating in or were in another new drug or device or in any medical research study in the last 30 days
  • Currently have or used to have allergies or other health problems or laboratory test results that in the opinion of the doctor, could make it unsafe for the participant to participate, or interfere with understanding the results of this study
  • Have received live vaccine(s) within 1 month of screening, or intend to during the study
  • Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
  • Have a weakened immune system
  • Have previously completed or withdrawn from this study
Show all 17Show fewer
  • Have illnesses or conditions that may increase risk when taking the study medication or interfere with the interpretation of data in this study
  • Have electrocardiogram (ECG) readings that are not suitable for the study
  • Are using or intend to use over-the-counter medications or prescription medications within 7 and 14 days (respectively) from the start of the first study dosing until end of the study
  • Have a history of drug or alcohol abuse
  • Are infected with hepatitis B
  • Are infected with human immunodeficiency virus (HIV)
  • Have donated 450 milliliters (mL) or more of blood in the last 3 months or made any blood donation within the last month
  • Have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are unwilling to abstain from alcohol 24 hours before dosing until the completion of each inpatient study period
  • Smoke more than 10 cigarettes per day or are unable or unwilling to refrain from smoking while at the clinic
  • Are unwilling or unable to follow dietary requirements/restrictions for the study and only consume only the meals provided during inpatient stays at the clinical research unit
  • Are deemed unsuitable to participate by the study doctor for any other reasons

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 from 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 Single Ascending Dose (SAD) Study of LY3009385 in Healthy Volunteers

The main purpose of this study is to determine the safety of LY3009385 in healthy participants. The study drug is given as a single dose, by injections under the skin. Side effects will be documented. This study is approximately 28 days not including screening. Screening is required within 28 days prior to the start of the study.

Read the detailed description

This is a single ascending dose study that examines the safety and tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) effects of single doses of LY3009385 administered subcutaneously to healthy participants. The planned dose levels are 0.3, 1, 3, 9, 27, and 54 milligrams (mg). Within each dose level, participants are randomized to receive either LY3009385 or Placebo.

Adjustments to the dose levels were permitted after review of emerging safety, PK, and glycemic data.

The actual LY3009385 dose levels tested during this study were 0.3, 1, 3, 9, 22, and 54 mg.

Being tested
LY3009385, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • LY3009385Drug

  • PlaceboDrug

Study groups in NCT01477567
Study groupRoleWhat they receive
0.3 mg LY3009385ExperimentalLY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Receives: Drug: LY3009385
1 mg LY3009385ExperimentalLY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Receives: Drug: LY3009385
3 mg LY3009385ExperimentalLY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Receives: Drug: LY3009385
9 mg LY3009385ExperimentalLY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Receives: Drug: LY3009385
22 mg LY3009385ExperimentalLY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Receives: Drug: LY3009385
54 mg LY3009385ExperimentalLY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Receives: Drug: LY3009385
PlaceboPlacebo comparatorPlacebo: saline, subcutaneous (SC) injection, single dose on Day 1
Receives: Drug: Placebo

What is being measured

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

  1. Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs

    The number of participants with 1 or more AEs assessed as related to the study drug and is summarized cumulatively. In addition, the number of participants with 1 or more serious AEs is summarized cumulatively. A serious AE is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.

    Measured: Baseline through Day 28

Secondary outcomes (6)

  1. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385

    LY3009385 exposure in terms of AUC from time 0 extrapolated to infinity (AUC[0-inf]) is summarized.

    Measured: Predose through Day 28

  2. Pharmacokinetics: Maximum Concentration (Cmax)

    The maximum observed plasma concentration (Cmax) of LY3009385 is summarized.

    Measured: Predose through Day 28

  3. Change in Level of Blood Glucose Before and After a Standard Meal

    The effect of LY3009385 on postprandial blood glucose was evaluated. Change from baseline area under the glucose concentration-time curve from time 0 to 6 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.

    Measured: Baseline, Day 5, and Day 14

  4. Change in Level of C-peptide Before and After a Standard Meal

    The effect of LY3009385 on postprandial c-peptide was assessed. Change from baseline area under the c-peptide concentration-time curve from time 0 to 4 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) was calculated and summarized by treatment arm.

    Measured: Baseline, Day 5, and Day 14

  5. Change in Level of Glucagon Before and After a Standard Meal

    The effect of LY3009385 on postprandial glucagon levels was assessed. Change from baseline glucagon concentrations 2 hours after participants started eating a standardized breakfast (mixed-meal tolerance test) were calculated and summarized by treatment arm.

    Measured: Baseline, Day 14

  6. Number of Participants Forming Antibody to LY3009385

    The number of participants with postbaseline detection of LY3009385treatment-emergent (TE) antidrug antibodies (ADA), defined as a 4-fold increase in the ADA titer from baseline.

    Measured: Baseline through Day 28

Timeline

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

  1. First posted22 Nov 2011 (estimated)
  2. Study startNov 2011
  3. Primary completionMar 2012
  4. Study completionMar 2012

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01477567
Sponsor's protocol ID
14195
Other IDs
I5O-FW-GTCA
Status last verified
Oct 2014
First submitted
18 Nov 2011
Last updated
6 Oct 2014
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3009385 in people with Diabetes Mellitus, Type 2, 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 6 inclusion and 17 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 6 Oct 2014. 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. 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 6 Oct 2014). 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 Drug-related Adverse Events (AEs) or Any Serious AEs (time frame: Baseline through Day 28). 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 NCT01477567.

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 6 Oct 2014.

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