HealthyPhase 1NCT02972645
A Study of LY3305677 in Healthy Participants
A Phase 1 study testing LY3305677 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial summary
The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it. This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3305677
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Dec 2016to 14 Jul 2017
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overtly healthy as determined by medical history and physical examination
- Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product
- Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
- First generation Japanese participants or non-Japanese participants
- Have a body weight of more than 50 kilograms (kg)
Who cannot join
- Have participated within the last 3 months in a clinical trial involving an investigational product
- Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy
- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1
- Have undergone any form of bariatric surgery
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
- Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase
Show all 10Show fewer
- Show evidence of human immunodeficiency virus (HIV) or Hepatitis B or C
- Have used or intend to use medications that promote weight loss
- Have donated blood of more than 500 milliliter (mL) within the last month
- Currently smoke more than 10 cigarettes per day
Trial locations and contacts
1 site in 1 country.
United Kingdom1 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.
Leeds, LS2-9LH
About this study
Official title: A First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects
The purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it.
This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it.
This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).
Participation in this study is expected to last up to 16 weeks.
- Conditions
- Healthy
- Being tested
- LY3305677, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3305677Drug
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY3305677 | Experimental | Single escalating doses of LY3305677 administered subcutaneously (SC) Receives: Drug: LY3305677 |
| Placebo | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
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
Measured: Baseline to Study Completion (approximately 16 weeks)
Secondary outcomes (2)
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677
Measured: Day 1 Pre-dose through Day 85
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677
Measured: Day 1 Pre-dose through Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2016 (estimated)
- Study start5 Dec 2016
- Primary completion14 Jul 2017
- Study completion14 Jul 2017
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
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 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
- NCT02972645
- Sponsor's protocol ID
- 16350
- Other IDs
- I8P-MC-OXAA
- Status last verified
- Jul 2017
- First submitted
- 21 Nov 2016
- Last updated
- 24 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02972645
- Acronym / sponsor ID
- 16350
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Dec 2016 (actual)
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 23 Nov 2016 (estimated)
- 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 purpose of this study is to evaluate the safety of LY3305677 and any side effects that might be associated with it.
This study will also look at how much LY3305677 gets into the blood stream, how long it takes the body to remove it.
This study involves a single dose of LY3305677 administered by subcutaneous injection (SC).
Participation in this study is expected to last up to 16 weeks.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3305677 | Experimental | Drug: LY3305677Single escalating doses of LY3305677 administered subcutaneously (SC) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Overtly healthy as determined by medical history and physical examination
- Male participants: will agree to use a reliable method of birth control and will not donate sperm during the study and for at least 3 months following the last dose of the investigational product
- Female participants: women not of child-bearing potential due to surgical sterilization confirmed by medical history or menopause
- First generation Japanese participants or non-Japanese participants
- Have a body weight of more than 50 kilograms (kg)
Key exclusion criteria (10 listed)
- Have participated within the last 3 months in a clinical trial involving an investigational product
- Have known allergies to glucagon-like peptide-1 (GLP-1) analogs, or any components of the formulation, or history of significant atopy
- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or Day -1
- Have undergone any form of bariatric surgery
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
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 |
|---|---|---|
| LY3305677Administered SC | Drug | LY3305677 |
| PlaceboAdministered SC | Drug | Placebo |
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 to Study Completion (approximately 16 weeks)
2 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) of LY3305677
Time frame: Day 1 Pre-dose through Day 85
Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of LY3305677
Time frame: Day 1 Pre-dose through Day 85
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 24 Jul 2017.
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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 LY3305677 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
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 5 inclusion and 10 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 24 Jul 2017. 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 Kingdom. 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 to Study Completion (approximately 16 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 24 Jul 2017.