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HealthyPhase 1NCT03025009

A Study of LY3192767 in Healthy Participants

A Phase 1 study testing LY3192767, Basal Insulin Peglispro and Insulin Glargine in people with Healthy, run by Eli Lilly and Company at 1 site in Germany.

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 investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood… Read more about this study

Who is it for?
Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
LY3192767, Basal Insulin Peglispro and Insulin Glargine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
57 participants
Where
1 siteGermany
Study dates
6 Mar 2017to 11 Apr 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 20 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Are overtly healthy males or females, as determined by medical history and physical examination
  • Have a body mass index (BMI) of >18.5 and <30.0 kilogram per square meter (kg/m²), inclusive

Who cannot join

  • Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
  • Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
  • Have participated as a participant in a first-in-human study within 90 days of the initial dose of study drug
  • Have known allergies to insulin, heparin, or related drugs, or history of relevant allergic reactions of any origin
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, chronic inflammatory disease, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data

Trial locations and contacts

1 site in 1 country.

Germany1 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.

    Neuss, North Rhine-Westphalia, 41460

Other trials in Germany

About this study

Official title: A Single-Site, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Glucodynamic Effects of LY3192767 in Healthy Subjects

The main purpose of this study is to investigate the side effects related to LY3192767 when given as an injection under the skin to healthy participants. Blood tests will be done to check how much LY3192767 is absorbed into the bloodstream, how long it takes for the body to get rid of it, and how it affects blood sugar levels. The study has two parts: Part A and Part B. Each participant will enroll in one part. For each participant, Part A will last up to about 32 days after last dose and Part B will last up to about 49 days after last dose. Screening must be completed prior to study start.

Conditions
Healthy
Being tested
LY3192767, Basal Insulin Peglispro, Insulin Glargine, Placebo

What participants receive

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

  • LY3192767Drug

    Administered SC.

  • Basal Insulin PeglisproDrug

    Also called LY2605541

    Administered SC.

  • Insulin GlargineDrug

    Administered SC.

  • PlaceboDrug

    Administered SC.

Study groups in NCT03025009
Study groupRoleWhat they receive
LY3192767 (Part A)ExperimentalEscalating doses of LY3192767 administered subcutaneously (SC).
Receives: Drug: LY3192767
Placebo (Part A)Placebo comparatorPlacebo matching LY3192767 administered subcutaneously (SC).
Receives: Drug: Placebo
LY3192767 (Part B)ExperimentalLY3192767 administered as a SC injection in one of three study periods.
Receives: Drug: LY3192767
Basal Insulin Peglispro (Part B)Active comparatorBasal insulin peglispro administered as a SC injection in one of three study periods.
Receives: Drug: Basal Insulin Peglispro
Insulin Glargine (Part B)Active comparatorInsulin glargine administered as a SC injection in one of three study periods.
Receives: Drug: Insulin Glargine

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 Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

    Measured: Baseline through Study Completion (up to about Day 49)

Secondary outcomes (9)

  1. Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of LY3192767

    PK: Tmax of LY3192767

    Measured: Predose through 336 Hours

  2. PK: Maximum Serum Concentration (Cmax) of LY3192767

    PK: Cmax of LY3192767

    Measured: Predose through 336 Hours

  3. PK: Area Under the Concentration-Time Curve from Time Zero to Infinity (AUC[0-inf] of LY3192767

    PK: AUC(0-inf) of LY3192767

    Measured: Predose through 336 Hours

  4. Pharmacodynamics (PD): Total Amount of Glucose Infused (Gtot) of LY3192767

    PD: Total Amount of Glucose Infused (Gtot) of LY3192767

    Measured: Predose through 36 Hours During Clamp Procedure

  5. PD: Maximum Glucose Infusion Rate (Rmax) of LY3192767

    PD: Rmax of LY3192767

    Measured: Predose through 36 Hours During Clamp Procedure

  6. PD: Time of Maximum Glucose Infusion Rate (TRmax) of LY3192767

    PD: TRmax of LY3192767

    Measured: Predose through 36 Hours During Clamp Procedure

  7. PD: Change from Baseline in Free Fatty Acids

    PD: Change from Baseline in Free Fatty Acids

    Measured: Predose through 48 Hours Postdose

  8. PD: Change from Baseline in Glycerol

    PD: Change from Baseline in Glycerol

    Measured: Predose through 48 Hours Postdose

  9. PD: Change from Baseline in Triglycerides

    PD: Change from Baseline in Triglycerides

    Measured: Predose through 48 Hours Postdose

Timeline

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

  1. First posted19 Jan 2017 (estimated)
  2. Study start6 Mar 2017
  3. Primary completion11 Apr 2018
  4. Study completion11 Apr 2018

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
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03025009
Sponsor's protocol ID
16242
Other IDs
I8M-MC-BIXA, 2016-003274-40, 2016
Status last verified
Apr 2019
First submitted
17 Jan 2017
Last updated
5 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3192767, Basal Insulin Peglispro and Insulin Glargine in people with Healthy, run by Eli Lilly and Company at 1 site in Germany.

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 5 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 5 Apr 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 through Study Completion (up to about Day 49)). 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 NCT03025009.

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 5 Apr 2019.

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