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Diabetes Mellitus, Type 2Phase 1NCT03603704

A Study of LY3209590 in Japanese Participants With Type 2 Diabetes

A Phase 1 study testing LY3209590 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 3 sites in Japan.

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 evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
LY3209590
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
3 sitesJapan
Study dates
17 Aug 2018to 27 May 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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have T2DM diagnosed at least 1 year ago
  • Have hemoglobin A1c (HbA1c) ≥7.0% and ≤10.0% with fasting plasma glucose (FPG) ≥126 milligrams per deciliter (mg/dL) or HbA1c ≥6.5% and <7.0% with FPG ≥144 mg/dL at screening
  • Have body weight ≥54 kilograms and a body mass index >18.5 and ≤40.0 kilograms per square meter at screening

Who cannot join

  • Have received a total daily dose of insulin >1.2 units per kilogram at screening
  • Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening
  • Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction
  • Have a history of heart block or a repeated demonstration of abnormality in the 12-lead electrocardiogram at screening, which in the opinion of the investigator, increases the risks associated with participating in the study

Trial locations and contacts

3 sites in 1 country.

Japan3 sites

  • Hakata Clinic

    Fukuoka, 812-0025

  • P-one clinic

    Hachiōji, Tokyo, 192-0071

  • Sumida Hospital

    Sumida-ku, Tokyo, 130-0004

Other trials in Japan

About this study

Official title: A Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3209590 in Japanese Patients With Type 2 Diabetes Mellitus

The main purpose of this study is to evaluate the safety of a study drug known as LY3209590 in Japanese participants with type 2 diabetes. Side effects and tolerability will be documented. Blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. The study will last about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.

Being tested
LY3209590, 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.

  • LY3209590Drug

    Administered SC

  • PlaceboDrug

    Administered SC

Study groups in NCT03603704
Study groupRoleWhat they receive
LY3209590ExperimentalInsulin naïve participants with Type 2 Diabetes Mellitus received 5 mg and 10 mg LY3209590 administered subcutaneously (SC) in Cohort 1 and 2 respectively. Participants with T2DM received 20 mg LY3209590 administered subcutaneously in Cohort 3.
Receives: Drug: LY3209590
PlaceboActive comparatorParticipants from Cohort 1 and 2 received Placebo administered SC.
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 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 Day 28

Secondary outcomes (3)

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590

    PK: Cmax of LY3209590

    Measured: Baseline through Day 28

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3209590

    PK: AUC of LY3209590

    Measured: Baseline through Day 28

  3. Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose

    PD: Change from Baseline in Fasting Plasma Glucose

    Measured: Baseline through Day 15

Timeline

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

  1. First posted27 Jul 2018
  2. Study start17 Aug 2018
  3. Primary completion27 May 2019
  4. Study completion27 May 2019

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
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03603704
Sponsor's protocol ID
16552
Other IDs
I8H-JE-BDCF
Status last verified
1 Nov 2020
First submitted
18 Jul 2018
Last updated
17 Nov 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Nasu R, Oura T, Ohwaki K, Imori M, Furihata K. Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes. Diabetes Ther. 2025 Mar;16(3):513-526. doi: 10.1007/s13300-025-01695-x. Epub 2025 Feb 10.

    PubMed 39928225

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3209590 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 3 sites in Japan.

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 3 inclusion and 4 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 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Japan. 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 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 NCT03603704, which also lists 1 linked publication.

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 Nov 2020.

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