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Completed

NCT Number: NCT05086445

A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to learn about the side effects of LY3502970 when given to Japanese participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last up to 24 weeks, inclusive of screening and will include 10 visits to the study center.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation Heishinkai OPHAC Hospital, Osaka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females not of childbearing potential
  • Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year
  • Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤ 10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at screening
  • Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing.

Exclusion criteria

  • Have type 1 diabetes mellitus or latent autoimmune diabetes in adults.
  • Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
  • Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
  • Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligram per deciliter (mg/dL).
  • Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3× upper limit of normal (ULN).

Treatment and study plan

LY3502970

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

    Time frame: Baseline Through Follow-Up (Up To Week 15)

    A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment. An SAE is any adverse event from this study that results in 1 of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above. An overall summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.

Secondary outcomes

  1. Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970 on Day 1

    Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose)

    PK: Cmax of LY3502970.

  2. Part A: PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1

    Time frame: Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose)

    PK: AUC[0-tlast] of LY3502970.

  3. Part B: PK: Cmax of LY3502970 on Day 84

    Time frame: Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose)

    PK: Cmax of LY3502970.

  4. Part B: PK: AUC[0-tlast] of LY3502970 on Day 84

    Time frame: Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose)

    PK: AUC[0-tlast] of LY3502970.

  5. Change From Baseline in Fasting Glucose

    Time frame: Baseline through Day 85

    Change from Baseline in Fasting Glucose was reported. Least square mean was calculated using the model: Log(Parameter) - Log(Baseline) = Log(Baseline) + Treatment + Timepoint + Treatment*Timepoint + Participant + Random Error, where participant was fitted as a random effect.

  6. Change From Baseline in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline through Day 85

    Change from Baseline in HbA1c. Least square mean was calculated using model Log(Parameter) - Log(Baseline) = Log(Baseline) + Treatment + Timepoint + Treatment*Timepoint + Participant + Random Error, where participant is fitted as a random effect

  7. Change From Baseline in Body Weight

    Time frame: Baseline through Day 88

    Change from Baseline in Body Weight. Least square mean was calculated using Model: Change from baseline = Baseline + Treatment + Time + Treatment*Time + participant + Random Error, where participant was fitted as a random effect

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 21, 2021
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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