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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080223988
Enrollment
Unknown
Registered
2018-07-27
Start date
2018-07-27
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes mellitus

Interventions

investigational material(s) Generic name etc : LY3209590 INN of investigational material : Therapeutic category code : 396 Antidiabetic agents Dosage and Administration for Investigational material :

Sponsors

Eli Lilly Japan K.K.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1. Have T2DM diagnosed at least 1 year 2. Have hemoglobin A1c (HbA1c) >=7.0% and =126 mg/dL, or HbA1c >=6.5% and =144 mg/dL, at screening 3. Have a body weight of >=54 kg, and a body mass index of >18.5 and <=40.0 kg/m2 at screening

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Have received a total daily dose of insulin >1.2 U/kg at screening 2. Have taken any glucose-lowering medications, other than basal insulin, metformin and dipeptidyl peptidase-IV inhibitor, in the past 3 months before screening 3. Have a history of multiple and/or severe allergies to drugs or foods, or a history of severe anaphylactic reaction. 4. Have a history of heart block, or a repeated demonstration of abnormality in the 12-lead ECG at screening, in the opinion of the investigator, increases the risks associated with participating in the study

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026