Diabetes Mellitus, Type 2Phase 1NCT05086445

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

A Phase 1 study testing LY3502970 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 5 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 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. 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?: LY3502970
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 62 participants
Where: 5 sitesJapan
Study dates: 12 Nov 2021to 5 Sep 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

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.

Who cannot join

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).

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Japan5 sites

P-One Clinic
Hachiōji, Tokyo, 192-0071
Medical Corporation Heishinkai OPHAC Hospital
Osaka, Osaka, 532-0003
Clinical Research Hospital Tokyo
Shinjuku-ku, Tokyo, 162-0053
Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic
Toshima City, Tokyo, 171-0014
Yokohama Minoru Clinic
Yokohama, 232-0064

Other trials in Japan

About this study

Official 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

Conditions: Diabetes Mellitus, Type 2
Being tested: LY3502970, 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.

LY3502970Drug
Administered orally
PlaceboDrug
Administered orally

Study groups in NCT05086445
Study group	Role	What they receive
LY3502970 (Part A)	Experimental	Participants received single doses of LY3502970 administered orally. Receives: Drug: LY3502970
LY3502970 (Part B)	Experimental	Participants received multiple doses of LY3502970 administered orally. Receives: Drug: LY3502970
Placebo (Part A)	Placebo comparator	Participants received placebo administered orally. Receives: Drug: Placebo
Placebo (Part B)	Placebo comparator	Participants received placebo administered orally. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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.
Measured: Baseline Through Follow-Up (Up To Week 15)

Secondary outcomes (7)

Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970 on Day 1
PK: Cmax of LY3502970.
Measured: 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
PK: AUC[0-tlast] of LY3502970.
Measured: Day 1 (Pre-dose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72 and 96 hours post-dose)
Part B: PK: Cmax of LY3502970 on Day 84
PK: Cmax of LY3502970.
Measured: 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
PK: AUC[0-tlast] of LY3502970.
Measured: Day 84 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 96 and 336 hours post-dose)
Change From Baseline in Fasting Glucose
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.
Measured: Baseline through Day 85
Change From Baseline in Glycated Hemoglobin (HbA1c)
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
Measured: Baseline through Day 85
Change From Baseline in Body Weight
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
Measured: Baseline through Day 88

Timeline

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

12 Nov 20215 Sep 2022

First posted21 Oct 2021
Study start12 Nov 2021
Primary completion5 Sep 2022
Study completion5 Sep 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05086445
Sponsor's protocol ID: 17610
Other IDs: J2A-JE-GZGB
Status last verified: 1 Jun 2026
First submitted: 20 Oct 2021
Last updated: 16 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 2 trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05086445
Acronym / sponsor ID: 17610
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 12 Nov 2021 (actual)
Primary completion: 5 Sep 2022 (actual)
Study completion: 5 Sep 2022 (actual)
First posted: 21 Oct 2021 (actual)
Results: Posted 16 Jul 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
LY3502970 (Part A)	Experimental	Drug: LY3502970Participants received single doses of LY3502970 administered orally.
LY3502970 (Part B)	Experimental	Drug: LY3502970Participants received multiple doses of LY3502970 administered orally.
Placebo (Part A)	Placebo comparator	Drug: PlaceboParticipants received placebo administered orally.
Placebo (Part B)	Placebo comparator	Drug: PlaceboParticipants received placebo administered orally.

Who may qualify

Ages: 20 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LY3502970Administered orally	Drug	LY3502970 (Part A), LY3502970 (Part B)
PlaceboAdministered orally	Drug	Placebo (Part A), Placebo (Part B)

Primary outcome

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.

7 secondary outcomes

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)
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)
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)
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)
Change From Baseline in Fasting Glucose
Time frame: Baseline through Day 85
Change From Baseline in Glycated Hemoglobin (HbA1c)
Time frame: Baseline through Day 85
Change From Baseline in Body Weight
Time frame: Baseline through Day 88

Results and safety

Results posted to the registry on 16 Jul 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1a - Placebo	2	2
Cohort 1a - LY3502970	10	8
Cohort 2a - Placebo	2	2
Cohort 2a - LY3502970	9	9
Cohort 1b - Placebo QD	0	0
Cohort 1b - LY3502970 QD	0	0
Cohort 2b - Placebo QD	0	0
Cohort 2b - LY3502970 QD	0	0
Cohort 3a - Placebo QD	0	0
Cohort 3a - LY3502970 QD	0	0
Cohort 3b - Placebo QD	0	0
Cohort 3b - LY3502970 QD	0	0

Primary outcome: 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). Count of participants. Unit: Participants

Measure	Placebo - Part A n = 4	2 mg LY3502970 - Part A n = 10	3 mg LY3502970 - Part A n = 9	Placebo QD - Part B n = 11	2(or 3)/3/6/12 mg LY3502970 QD - Part B n = 14	2/3/6/8/12/24 mg LY3502970 QD - Part B n = 17	2(or 3)/3/6/12/24/36/45 mg LY3502970 QD - Part B n = 18
TEAEs	2	5	5	4	11	12	9
SAEs	0	0	0	0	0	0	0

Population analysed: All participants from Part A and Part B who received at least one dose of study drug. For Part B, as specified in the statistical analysis plan, analyses were performed for the pre-specified treatment groups: placebo, 2(or 3)/3/6/12 mg LY3502970, 2/3/6/8/12/24 mg LY3502970, and 2(or 3)/6/12/24/36/45 mg LY3502970.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline Through Follow-Up (Up To Week 15). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo - Part A	0 of 4 (0%)	2 of 4 (50%)	0 of 4
2 mg LY3502970 - Part A	0 of 10 (0%)	5 of 10 (50%)	0 of 10
3 mg LY3502970 - Part A	0 of 9 (0%)	6 of 9 (66.7%)	0 of 9
Placebo QD - Part B	0 of 11 (0%)	5 of 11 (45.5%)	0 of 11
2(or 3)/3/6/12 mg LY3502970 QD - Part B	0 of 14 (0%)	11 of 14 (78.6%)	0 of 14
2/3/6/8/12/24 mg LY3502970 QD - Part B	0 of 17 (0%)	13 of 17 (76.5%)	0 of 17
2(or 3)/3/6/12/24/36/45 mg LY3502970 QD - Part B	0 of 18 (0%)	9 of 18 (50%)	0 of 18

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
A Study of LY3502970 in Japanese Participants With Type 2 Diabetes MellitusLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing LY3502970 in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 5 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 4 inclusion and 5 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 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 16 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 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)). 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 NCT05086445.

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 16 Jul 2026.