HealthyPhase 1NCT06869018
A Study of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants
A Phase 1 study testing LY3549492 in people with Healthy and Type 2 Diabetes Mellitus (T2D), run by Eli Lilly and Company at 4 sites in Japan.
Trial summary
The purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants. The study drug will be administered orally. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Type 2 Diabetes Mellitus (T2D)
- What is being tested?
- LY3549492
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 4 sitesJapan
- Study dates
- 7 May 2025to 2 Mar 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A:
- Participants with T2DM for at least 6 months
- With an HbA1c value:
- equal to or greater than 7.0% and equal to or less than 10.0% at screening for participants treated with diet and exercise alone, OR
- equal to or greater than 6.5% and equal to or less than 9.0% for participants prior to washout of antidiabetic medications
- Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change
- Part B:
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results
Who cannot join
- Have a known clinically significant gastric emptying abnormality
- Have a 12-lead electrocardiogram (ECG) abnormality
- Have an abnormal blood pressure or pulse rate
- Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug
- Have a history of chronic medical conditions involving the heart, liver, or kidneys
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Hakata Clinic
Fukuoka, 812-0025
P-One Clinic
Hachiōji, 192-0071
Medical Corporation Heishinkai OPHAC Hospital
Osaka, 532-0003
Clinical Research Hospital Tokyo
Shinjuku-ku, 160-0004
About this study
Official title: A Randomized, Investigator- and Participant-blinded, Multiple-ascending Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus and Healthy Japanese Participants
The purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3549492 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 19 weeks for both Part A (Cohorts 1-3) for multiple-ascending doses (MAD), and Part B (Cohorts 4-5) multiple-ascending doses (MAD), for a total of approximately 25 weeks, including screening.
- Conditions
- Healthy, Type 2 Diabetes Mellitus (T2D)
- Being tested
- LY3549492, Placebo
- Keywords
- Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3549492Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3549492 Part A | Experimental | LY3549492 administered orally Receives: Drug: LY3549492 |
| LY3549492 Part B | Experimental | LY3549492 administered orally Receives: Drug: LY3549492 |
| Placebo Part A | Placebo comparator | Placebo administered orally Receives: Drug: Placebo |
| Placebo Part B | Placebo comparator | 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 summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Day 1 Through Day 127
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492
PK: AUC of LY3549492
Measured: Day 1 Through Day 127
PK: Maximum Concentration (Cmax) of LY3549492
PK: Cmax of LY3549492
Measured: Day 1 Through Day 127
Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c)
PD: Change from Baseline in Hemoglobin A1c (HbA1c)
Measured: Day 1 Through Day 127
PD: Change from Baseline in Body Weight
PD: Change from Baseline in Body Weight
Measured: Day 1 Through Day 127
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start7 May 2025
- Primary completion2 Mar 2026
- Study completion2 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869018
- Sponsor's protocol ID
- 27338
- Other IDs
- J3H-JE-GZNG
- Status last verified
- Mar 2026
- First submitted
- 10 Mar 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Investigator- and Participant-blinded, Multiple-ascending Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3549492 in Japanese Participants With Type 2 Diabetes Mellitus and Healthy Japanese Participants
- ClinicalTrials.gov ID
- NCT06869018
- Acronym / sponsor ID
- 27338
- Conditions
- Healthy, Type 2 Diabetes Mellitus (T2D)
- Keywords
- Glucose Metabolism Disorders, Metabolic Diseases, Endocrine System Diseases, Diabetes Mellitus, Diabetes Mellitus, Type 2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 7 May 2025 (actual)
- Primary completion
- 2 Mar 2026 (actual)
- Study completion
- 2 Mar 2026 (actual)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate how well LY3549492 is tolerated and what side effects may occur in Japanese participants with Type 2 Diabetes Mellitus (T2D) and healthy Japanese participants. The study drug will be administered orally. Blood tests will be performed to check how much LY3549492 gets into the bloodstream and how long it takes the body to eliminate it.
The study will last up to approximately 19 weeks for both Part A (Cohorts 1-3) for multiple-ascending doses (MAD), and Part B (Cohorts 4-5) multiple-ascending doses (MAD), for a total of approximately 25 weeks, including screening.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LY3549492 Part A | Experimental | Drug: LY3549492LY3549492 administered orally |
| LY3549492 Part B | Experimental | Drug: LY3549492LY3549492 administered orally |
| Placebo Part A | Placebo comparator | Drug: PlaceboPlacebo administered orally |
| Placebo Part B | Placebo comparator | Drug: PlaceboPlacebo administered orally |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participants with T2DM for at least 6 months
- With an HbA1c value:
- Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results
Key exclusion criteria (5 listed)
- Have a known clinically significant gastric emptying abnormality
- Have a 12-lead electrocardiogram (ECG) abnormality
- Have an abnormal blood pressure or pulse rate
- Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug
- Have a history of chronic medical conditions involving the heart, liver, or kidneys
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 |
|---|---|---|
| LY3549492Administered orally | Drug | LY3549492 Part A, LY3549492 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: Day 1 Through Day 127
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
4 secondary outcomes
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3549492
Time frame: Day 1 Through Day 127
PK: Maximum Concentration (Cmax) of LY3549492
Time frame: Day 1 Through Day 127
Pharmacodynamic (PD): Part A: Change from Baseline in Hemoglobin A1c (HbA1c)
Time frame: Day 1 Through Day 127
PD: Change from Baseline in Body Weight
Time frame: Day 1 Through Day 127
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
4 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 LY3549492 in people with Healthy and Type 2 Diabetes Mellitus (T2D), run by Eli Lilly and Company at 4 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 8 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 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: Day 1 Through Day 127). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Mar 2026.