Diabetes Mellitus, Type 2Phase 1NCT01588366

The Effects of LY2409021 on the Liver

A Phase 1 study testing LY2409021 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

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: LY2409021
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 30 participants
Where: 1 siteSingapore
Study dates: Apr 2012to Sep 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 21 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

For all participants:
Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
Must have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2) if a healthy participant, or a BMI of 18.5 to 35.0 kg/m^2 if diabetic
For participants with type 2 diabetes mellitus (T2DM):
On diet and exercise treatment, or taking metformin

Who cannot join

For all participants:
Have signs or symptoms of liver disease
Are infected with hepatitis B or hepatitis C
Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
Have had surgery with metallic clips, staples or stents, or have had a cardiac pacemaker (or other surgical implants) inserted in any part of the body, or have fear of enclosed spaces or have symptoms that prevent them from being sent for an magnetic resonance imaging (MRI) scan
For participants with T2DM:
Are using insulin

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: Effects of LY2409021 on Hepatic Metabolism in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus

This is a study that involves multiple doses of study drug (60 mg of LY2409021, 15 mg of LY2409021 or placebo) taken as capsules by mouth on a daily basis for 28 days. This study will image the liver using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS) in healthy participants and in participants with type 2 diabetes mellitus, when they take LY2409021 to see if liver changes happen at the same time as changes in blood tests. This study is approximately 11 weeks long, not including screening. A screening appointment is required within 28 days prior to the start of the study.

Conditions: Diabetes Mellitus, Type 2
Being tested: Placebo, LY2409021
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.

PlaceboDrug
Administered orally
LY2409021Drug
Administered orally

Study groups in NCT01588366
Study group	Role	What they receive
Placebo	Placebo comparator	Part A and B - Up to 4 capsules of placebo administered orally once a day for 28 days. Receives: Drug: Placebo
15 mg LY2409021	Experimental	Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.) Receives: Drug: LY2409021
60 mg LY2409021	Experimental	Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days. Receives: Drug: LY2409021

What is being measured

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

Change From Baseline to Day 28 in Liver Fat Average Percent (%)
Measured by magnetic resonance (MR) scanning.
Measured: Baseline, Day 28 (Pre-meal)
Change From Baseline to Day 28 in Hepatic Glycogen Content
Measured by MR scanning.
Measured: Baseline, Day 28 (Pre-meal)

Secondary outcomes (4)

Change From Baseline to Day 28 in Transaminase Levels
Measured: Baseline, Day 28
Change From Baseline to Day 29 in Glucose Response to an Arginine Stimulation Test (AST) (Part A)
Acute glucose response to an AST at a blood glucose level of approximately 250 milligrams per deciliter (mg/dL).
Measured: Baseline, Day 29
Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A)
Acute glucagon response to an AST at a blood glucose level of approximately 250 mg/dL.
Measured: Baseline, Day 29
Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A)
Acute insulin response to an AST at a blood glucose level of approximately 250 mg/dL.
Measured: Baseline, Day 29

Timeline

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

Apr 2012Sep 2013

First posted1 May 2012 (estimated)
Study startApr 2012
Primary completionSep 2013
Study completionSep 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 Diabetes Mellitus, Type 2Studies 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
Masking: Single blind
Who is masked: Participant
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01588366
Sponsor's protocol ID: 13107
Other IDs: I1R-FW-GLBK
Status last verified: Nov 2018
First submitted: 27 Apr 2012
Last updated: 7 Mar 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: 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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of LY2409021 on Hepatic Metabolism in Healthy Volunteers and Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT01588366
Acronym / sponsor ID: 13107
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: Sep 2013 (actual)
Study completion: Sep 2013 (actual)
First posted: 1 May 2012 (estimated)
Results: Posted 7 Mar 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboPart A and B - Up to 4 capsules of placebo administered orally once a day for 28 days.
15 mg LY2409021	Experimental	Drug: LY2409021Part B - 1 capsule of 15 mg LY2409021 orally once a day for 28 days. (Arm added in September, 2012, per protocol amendment.)
60 mg LY2409021	Experimental	Drug: LY2409021Part A - 4 capsules of 15 mg LY2409021 administered orally once a day for 28 days.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
Must have a body mass index (BMI) of 18.5 to 29.9 kilograms per square meter (kg/m^2) if a healthy participant, or a BMI of 18.5 to 35.0 kg/m^2 if diabetic
On diet and exercise treatment, or taking metformin

Key exclusion criteria (8 listed)

Have signs or symptoms of liver disease
Are infected with hepatitis B or hepatitis C
Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic
Have had surgery with metallic clips, staples or stents, or have had a cardiac pacemaker (or other surgical implants) inserted in any part of the body, or have fear of enclosed spaces or have symptoms that prevent them from being sent for an magnetic resonance imaging (MRI) scan

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
PlaceboAdministered orally	Drug	Placebo
LY2409021Administered orally	Drug	15 mg LY2409021, 60 mg LY2409021

Primary outcome

Change From Baseline to Day 28 in Liver Fat Average Percent (%)
Time frame: Baseline, Day 28 (Pre-meal)
Measured by magnetic resonance (MR) scanning.
Change From Baseline to Day 28 in Hepatic Glycogen Content
Time frame: Baseline, Day 28 (Pre-meal)
Measured by MR scanning.

4 secondary outcomes

Change From Baseline to Day 28 in Transaminase Levels
Time frame: Baseline, Day 28
Change From Baseline to Day 29 in Glucose Response to an Arginine Stimulation Test (AST) (Part A)
Time frame: Baseline, Day 29
Change From Baseline to Day 29 in Glucagon Response to an Arginine Stimulation Test (AST) (Part A)
Time frame: Baseline, Day 29
Change From Baseline to Day 29 in Insulin Response to an Arginine Stimulation Test (AST) (Part A)
Time frame: Baseline, Day 29

Results and safety

Results posted to the registry on 7 Mar 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo - Healthy (Part A)	2	2
60 mg LY2409021 - Healthy (Part A)	7	6
Placebo - T2DM (Part A)	2	2
60 mg LY2409021 - T2DM (Part A)	7	6
Placebo - T2DM (Part B)	3	3
15 mg LY2409021 - T2DM (Part B)	9	7

Primary outcome: Change From Baseline to Day 28 in Liver Fat Average Percent (%)

Time frame: Baseline, Day 28 (Pre-meal). Mean (95% Confidence Interval). Unit: percentage of liver fat average

Measure	Placebo - Healthy (Part A) n = 2	60 mg LY2409021 - Healthy (Part A) n = 6	Placebo - T2DM (Parts A and B) n = 5	15 mg LY2409021 - T2DM (Part B) n = 7	60 mg LY2409021 - T2DM (Part A) n = 6
Value	-0.47 (NA to NA)	5.55 (0.346 to 10.7)	-1.49 (-5.00 to 2.03)	4.45 (1.66 to 7.24)	5.84 (3.17 to 8.51)

Population analysed: All participants who had evaluable MR scans at Baseline and on Day 28.

Primary outcome: Change From Baseline to Day 28 in Hepatic Glycogen Content

Time frame: Baseline, Day 28 (Pre-meal). Mean (95% Confidence Interval). Unit: millimoles per liter (mmol/L)

Measure	60 mg LY2409021 - Healthy (Part A) n = 6	60 mg LY2409021 - T2DM (Part A) n = 5
Value	12.8 (-48.1 to 73.8)	42.1 (-8.18 to 92.4)

Population analysed: All participants in Part A who received 60 mg LY2409021 and had evaluable MR scans at Baseline and on Day 28.

4 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
Placebo - Healthy (Part A)	0 of 2 (0%)	1 of 2 (50%)	Not reported
60 mg LY2409021 - Healthy (Part A)	0 of 7 (0%)	7 of 7 (100%)	Not reported
Placebo - T2DM (Parts A and B)	0 of 5 (0%)	4 of 5 (80%)	Not reported
15 mg LY2409021 - T2DM (Part B)	2 of 9 (22.2%)	7 of 9 (77.8%)	Not reported
60 mg LY2409021 - T2DM (Part A)	0 of 7 (0%)	4 of 7 (57.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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 LY2409021 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 5 inclusion and 8 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 7 Mar 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. 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 7 Mar 2019). 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?

Change From Baseline to Day 28 in Liver Fat Average Percent (%) (time frame: Baseline, Day 28 (Pre-meal)). The study lists 2 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 NCT01588366.

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 7 Mar 2019.