NCT03603704

Brief 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. The study will last about four weeks, not including screening. Screening is required within 4 weeks before the start of the study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 diabetes-mellitus-type-2

Timeline
Completed

Started Aug 2018

Typical duration for phase_1 diabetes-mellitus-type-2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2018

Completed
21 days until next milestone

Study Start

First participant enrolled

August 17, 2018

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2019

Completed
Last Updated

November 17, 2020

Status Verified

November 1, 2020

Enrollment Period

9 months

First QC Date

July 18, 2018

Last Update Submit

November 13, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (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

    Baseline through Day 28

Secondary Outcomes (3)

  • Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3209590

    Baseline through Day 28

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

    Baseline through Day 28

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

    Baseline through Day 15

Study Arms (2)

LY3209590

EXPERIMENTAL

Insulin 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.

Drug: LY3209590

Placebo

ACTIVE COMPARATOR

Participants from Cohort 1 and 2 received Placebo administered SC.

Drug: Placebo

Interventions

LY3209590DRUG

Administered SC

LY3209590
PlaceboDRUG

Administered SC

Placebo

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

P-one clinic

Hachiōji, Tokyo, 192-0071, Japan

Location

Sumida Hospital

Sumida-ku, Tokyo, 130-0004, Japan

Location

Hakata Clinic

Fukuoka, 812-0025, Japan

Location

Related Publications (1)

  • 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.

    PMID: 39928225DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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)

    Eli Lilly and Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Cohort 3 is open-label.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2018

First Posted

July 27, 2018

Study Start

August 17, 2018

Primary Completion

May 27, 2019

Study Completion

May 27, 2019

Last Updated

November 17, 2020

Record last verified: 2020-11-01

Data Sharing

IPD Sharing
Will not share

Locations

JP(3)