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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT05086445 (opens ClinicalTrials.gov in a new tab)Other id17610Other idJ2A-JE-GZGB
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
62 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Double masking
Countries
1 country

Japan

Start
12 Nov 2021
Primary completion
5 Sept 2022
Completion
5 Sept 2022
First posted
21 Oct 2021
Last update posted
16 Jul 2026
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202120222023
  1. Ph 1

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

    NCT05086445

    12 Nov 2021 to 5 Sept 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LY3502970Drug
  • PlaceboDrug

Arms4

  • Experimental

    LY3502970 (Part A)

    Participants received single doses of LY3502970 administered orally.

  • Experimental

    LY3502970 (Part B)

    Participants received multiple doses of LY3502970 administered orally.

  • Placebo comparator

    Placebo (Part A)

    Participants received placebo administered orally.

  • Placebo comparator

    Placebo (Part B)

    Participants received placebo administered orally.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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)

    Registry description

    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(7)

  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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    PK: AUC\[0-tlast\] of LY3502970.

  5. Change From Baseline in Fasting Glucose

    Time frame · Baseline through Day 85

    Registry description

    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

    Registry description

    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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· Baseline Through Follow-Up (Up To Week 15)

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

GroupValue (Participants)
Placebo - Part A2
2 mg LY3502970 - Part A5
3 mg LY3502970 - Part A5
Placebo QD - Part B4
2(or 3)/3/6/12 mg LY3502970 QD - Part B11
2/3/6/8/12/24 mg LY3502970 QD - Part B12
2(or 3)/3/6/12/24/36/45 mg LY3502970 QD - Part B9
Secondary and other outcome results(7)
Secondary outcomeGeometric mean· Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose)

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

GroupValue (nanograms per milliliter (ng/mL))Spread
2 mg LY3502970 - Part A9.7034
3 mg LY3502970 - Part A18.138
Secondary outcomeGeometric least squares mean· Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose)

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

GroupValue (nanogram hour per milliliter (ng*h/mL))Spread
2 mg LY3502970 - Part A23630
3 mg LY3502970 - Part A41229
Secondary outcomeGeometric least squares mean· Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose)

Part B: PK: Cmax of LY3502970 on Day 84

GroupValue (nanograms per milliliter (ng/mL))Spread
12 mg LY3502970 - Part B11237
24 mg LY3502970 - Part B13942
45 mg LY3502970 - Part B27953
Secondary outcomeGeometric least squares mean· Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose)

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

GroupValue (nanogram hour per milliliter (ng*h/mL))Spread
12 mg LY3502970 - Part B586068
24 mg LY3502970 - Part B748083
45 mg LY3502970 - Part B1120080
Secondary outcomeLeast squares mean· Baseline through Day 85

Change From Baseline in Fasting Glucose

GroupValue (milligrams per deciliter (mg/dL))
Placebo QD - Part B7.40
2(or 3)/3/6/12 mg LY3502970 QD - Part B-64.82
2/3/6/8/12/24 mg LY3502970 QD - Part B-61.08
2(or 3)/3/6/12/24/36/45 mg LY3502970 QD - Part B-65.56
Secondary outcomeLeast squares mean· Baseline through Day 85

Change From Baseline in Glycated Hemoglobin (HbA1c)

GroupValue (Percentage of HbA1c)
Placebo QD - Part B0.67
2(or 3)/3/6/12 mg LY3502970 QD - Part B-2.16
2/3/6/8/12/24 mg LY3502970 QD - Part B-2.17
2(or 3)/3/6/12/24/36/45 mg LY3502970 QD - Part B-2.28
Secondary outcomeLeast squares mean· Baseline through Day 88

Change From Baseline in Body Weight

GroupValue (kilogram (kg))
Placebo QD - Part B-0.5
2(or 3)/3/6/12 mg LY3502970 QD - Part B-3.4
2/3/6/8/12/24 mg LY3502970 QD - Part B-6.9
2(or 3)/3/6/12/24/36/45 mg LY3502970 QD - Part B-4.9

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Placebo - Part AParticipants received a single oral dose of Placebo.0 / 40 / 42 / 4
2 mg LY3502970 - Part AParticipants received a single oral dose of 2 mg LY3502970.0 / 100 / 105 / 10
3 mg LY3502970 - Part AParticipants received a single oral dose of 3 mg LY3502970.0 / 90 / 96 / 9
Placebo QD - Part BParticipants received oral doses of Placebo QD for 12 weeks. Participants also consisted of those who received placebo and completed Part A.0 / 110 / 115 / 11
2(or 3)/3/6/12 mg LY3502970 QD - Part BParticipants received oral doses of LY3502970 QD as follows: 2 mg (1 week), 3 mg (1 week) or 3 mg (2 weeks). This was followed by 6 mg (2 weeks), and 12 mg (8 weeks).0 / 140 / 1411 / 14
2/3/6/8/12/24 mg LY3502970 QD - Part BParticipants received oral doses of LY3502970 QD as follows: 2 mg (1 week), 3 mg (1 week), 6 mg (1 week), 8 mg (1 week), 12 mg (1 week) and 24 mg (7 weeks). Participants also consisted of those who received 2 mg of LY3502970 and completed Part A.0 / 170 / 1713 / 17
2(or 3)/3/6/12/24/36/45 mg LY3502970 QD - Part BParticipants received oral doses of LY3502970 QD as follows: 2 mg (1 week), 3 mg (1 week) or 3 mg (2 weeks). This was followed by 6 mg (2 weeks), 12 mg (2 weeks), 24 mg (2 weeks), 36 mg (2 weeks), and 45 mg (2 weeks). Participants also consisted of those who received 3 mg of LY3502970 and completed Part A.0 / 180 / 189 / 18

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 20 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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).

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