HealthyPhase 1NCT03726125
A Study of LY3374849 in Healthy Participants
A Phase 1 study testing LY3374849 - SC, Insulin Degludec - SC and LY3374849 - IV in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The aim of this trial is to evaluate the safety and tolerability of the study drug known as LY3374849, when given as an injection to healthy participants. The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and how it affects the levels of blood sugar in comparison to insulin… Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3374849 - SC, Insulin Degludec - SC and LY3374849 - IV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Nov 2018to 27 Sep 2019
- 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or a female who cannot become pregnant
- Have a body mass index (BMI) of at least 18 kilogram per square meter (kg/m²)
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- Have veins suitable for easy blood collection and glucose solution infusion
Who cannot join
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Had donated or had blood loss of more than 450 milliliters (mL) within the last 3 months
- Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
- Smoke more than 10 cigarettes per day
- Are infected with hepatitis B or human immunodeficiency virus (HIV)
- Have a history of allergies or reactions to more than one drug, or significant severe drug allergy
- Are taking illegal drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects
The aim of this trial is to evaluate the safety and tolerability of the study drug known as LY3374849, when given as an injection to healthy participants.
The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and how it affects the levels of blood sugar in comparison to insulin degludec, after a single dose is given by injection under the skin and directly into a vein.
Read more
Participation in this study includes screening, which is required within 28 days before start of study and a follow up at least 28 days after receiving the last dose of study drug.
This study has 3 parts:
- Participants in Part A will complete 1 study period (approximately 1 week).
- Participants in Part B will complete 3 study periods (approximately 3 weeks).
- Participants in Part C will complete 2 study periods (approximately 2 weeks).
Read the detailed description
Parts B and C added per protocol amendment, approved in April 2019.
- Conditions
- Healthy
- Being tested
- LY3374849 - SC, Insulin Degludec - SC, LY3374849 - IV, Insulin Degludec - IV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3374849 - SCDrug
Administered SC
Insulin Degludec - SCDrug
Administered SC
LY3374849 - IVDrug
Administered IV
Insulin Degludec - IVDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3374849 - SC (Part A) | Experimental | Single subcutaneous (SC) dose of LY3374849 Receives: Drug: LY3374849 - SC |
| Insulin Degludec - SC (Part A) | Experimental | Single SC dose of insulin degludec Receives: Drug: Insulin Degludec - SC |
| LY3374849 - SC (Part B) | Experimental | Single dose of LY3374849 administered SC in up to three of three study periods Receives: Drug: LY3374849 - SC |
| LY3374849 - IV (Part B) | Experimental | Single dose of LY3374849 administered intravenously (IV) in up to one of three study periods Receives: Drug: LY3374849 - IV |
| LY3374849 - IV (Part C) | Experimental | Single IV dose of LY3374849 in one of two study periods Receives: Drug: LY3374849 - IV |
| Insulin Degludec - IV (Part C) | Experimental | Single IV dose of insulin degludec in one of two study periods Receives: Drug: Insulin Degludec - IV |
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 SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline up to study completion (estimated at 11 weeks)
Secondary outcomes (2)
Glucodynamics: Total Amount of Glucose Infused (Gtot)
Glucodynamics: Gtot
Measured: Baseline up to 36 hours post-dose for each study arm
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849
Pharmacokinetics: AUC of LY3374849
Measured: Baseline at predose through 6 days post-dose for each study arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2018
- Study start20 Nov 2018
- Primary completion27 Sep 2019
- Study completion27 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Parts B and C are crossover design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726125
- Sponsor's protocol ID
- 16939
- Other IDs
- I9R-MC-BSDA
- Status last verified
- 15 Oct 2019
- First submitted
- 3 Oct 2018
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 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, Pharmacokinetic, and Glucodynamic Effects of LY3374849 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03726125
- Acronym / sponsor ID
- 16939
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 27 Sep 2019 (actual)
- Study completion
- 27 Sep 2019 (actual)
- First posted
- 31 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this trial is to evaluate the safety and tolerability of the study drug known as LY3374849, when given as an injection to healthy participants.
The study will also investigate how quickly the body absorbs and gets rid of LY3374849 and how it affects the levels of blood sugar in comparison to insulin degludec, after a single dose is given by injection under the skin and directly into a vein.
Participation in this study includes screening, which is required within 28 days before start of study and a follow up at least 28 days after receiving the last dose of study drug.
This study has 3 parts:
- Participants in Part A will complete 1 study period (approximately 1 week).
- Participants in Part B will complete 3 study periods (approximately 3 weeks).
- Participants in Part C will complete 2 study periods (approximately 2 weeks).
Detailed description
Parts B and C added per protocol amendment, approved in April 2019.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Parts B and C are crossover design.
| Arm | Type | Receives |
|---|---|---|
| LY3374849 - SC (Part A) | Experimental | Drug: LY3374849 - SCSingle subcutaneous (SC) dose of LY3374849 |
| Insulin Degludec - SC (Part A) | Experimental | Drug: Insulin Degludec - SCSingle SC dose of insulin degludec |
| LY3374849 - SC (Part B) | Experimental | Drug: LY3374849 - SCSingle dose of LY3374849 administered SC in up to three of three study periods |
| LY3374849 - IV (Part B) | Experimental | Drug: LY3374849 - IVSingle dose of LY3374849 administered intravenously (IV) in up to one of three study periods |
| LY3374849 - IV (Part C) | Experimental | Drug: LY3374849 - IVSingle IV dose of LY3374849 in one of two study periods |
| Insulin Degludec - IV (Part C) | Experimental | Drug: Insulin Degludec - IVSingle IV dose of insulin degludec in one of two study periods |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy male or a female who cannot become pregnant
- Have a body mass index (BMI) of at least 18 kilogram per square meter (kg/m²)
- Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study
- Have veins suitable for easy blood collection and glucose solution infusion
Key exclusion criteria (7 listed)
- Are currently participating in or completed a clinical trial within the last 30 days or any other type of medical research judged to be incompatible with this study
- Had donated or had blood loss of more than 450 milliliters (mL) within the last 3 months
- Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female)
- Smoke more than 10 cigarettes per day
- Are infected with hepatitis B or human immunodeficiency virus (HIV)
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 |
|---|---|---|
| LY3374849 - SCAdministered SC | Drug | LY3374849 - SC (Part A), LY3374849 - SC (Part B) |
| Insulin Degludec - SCAdministered SC | Drug | Insulin Degludec - SC (Part A) |
| LY3374849 - IVAdministered IV | Drug | LY3374849 - IV (Part B), LY3374849 - IV (Part C) |
| Insulin Degludec - IVAdministered IV | Drug | Insulin Degludec - IV (Part C) |
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 up to study completion (estimated at 11 weeks)
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
2 secondary outcomes
Glucodynamics: Total Amount of Glucose Infused (Gtot)
Time frame: Baseline up to 36 hours post-dose for each study arm
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3374849
Time frame: Baseline at predose through 6 days post-dose for each study arm
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Individual participant dataSharing planned: No
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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 LY3374849 - SC, Insulin Degludec - SC and LY3374849 - IV 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 4 inclusion and 7 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 17 Oct 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?
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 up to study completion (estimated at 11 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2019.