Type 2 DiabetesPhase 1NCT07073170
A Study of LY3549492 in Chinese Participants With Type 2 Diabetes Mellitus
A Phase 1 study testing LY3549492 in people with Type 2 Diabetes, run by Eli Lilly and Company at 3 sites in China.
Trial summary
The main purpose of this study is to investigate LY3549492 in Chinese participants with type 2 diabetes. Participation in the study will last about 18 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 2 Diabetes
- 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
- 36 participants
- Where
- 3 sitesChina
- Study dates
- 25 Jul 2025to 27 Jan 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are native Chinese
- Have type 2 diabetes for at least 6 months
- Have been treated with diet and exercise, with or without a stable dose of metformin for at least 3 months
- Have hemoglobin A1c (HbA1c) of at least 7% and no greater than 10%
- Have a body mass index (BMI) of at least 20 milligrams per square meter (kg/m2) and no greater than 40 kg/m2
- Have had a stable body weight for the 3 months prior to screening
- Women must not be of childbearing potential
Who cannot join
- Have type 1 diabetes or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization
- Have had an episode of severe hypoglycemia within 6 months or have a history of hypoglycemia unawareness
- Have a clinically significant gastric emptying abnormality
- Have or have a history of pancreatitis
- Have signs and symptoms of liver disease, with the exception of non-alcoholic fatty liver disease
- Have a personal or family history of multiple endocrine neoplasia syndrome type 2 or medullary thyroid carcinoma
Show all 10Show fewer
- Have an uncontrolled endocrine abnormality
- Have an abnormal blood pressure or pulse rate
- Have a 12-lead electrocardiogram (ECG) abnormality
- Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study intervention, or of interfering with the interpretation of data
Trial locations and contacts
3 sites in 1 country.
China3 sites
Peking University People's Hospital
Beijing, 100033
West China Hospital of Sichuan University
Chengdu, 610041
Peking University First Hospital
Dongcheng District, 100009
About this study
Official title: A Phase 1, Participant- and Investigator-Blind, Placebo-Controlled, Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Daily Doses of LY3549492 in Chinese Participants With Type 2 Diabetes Mellitus
The main purpose of this study is to investigate LY3549492 in Chinese participants with type 2 diabetes. Participation in the study will last about 18 weeks.
- Conditions
- Type 2 Diabetes
- Being tested
- LY3549492, 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.
LY3549492Drug
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| LY3549492 Dose 1 | Experimental | Participants will receive LY3549492 orally Receives: Drug: LY3549492 |
| LY3549492 Dose 2 | Experimental | Participants will receive LY3549492 orally Receives: Drug: LY3549492 |
| LY3549492 Dose 3 | Experimental | Participants will receive LY3549492 orally Receives: Drug: LY3549492 |
| Placebo | Placebo comparator | Participants will receive Placebo 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 Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
Measured: Baseline through Week 14
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3549492
Measured: Predose through Week 13
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492
Measured: Predose through Week 13
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start25 Jul 2025
- Primary completion27 Jan 2026
- Study completion27 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- 36 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
- NCT07073170
- Sponsor's protocol ID
- 27335
- Other IDs
- J3H-GH-GZNH
- Status last verified
- Mar 2026
- First submitted
- 10 Jul 2025
- Last updated
- 3 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 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Participant- and Investigator-Blind, Placebo-Controlled, Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Daily Doses of LY3549492 in Chinese Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT07073170
- Acronym / sponsor ID
- 27335
- Conditions
- Type 2 Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 27 Jan 2026 (actual)
- Study completion
- 27 Jan 2026 (actual)
- First posted
- 18 Jul 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 main purpose of this study is to investigate LY3549492 in Chinese participants with type 2 diabetes. Participation in the study will last about 18 weeks.
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 Dose 1 | Experimental | Drug: LY3549492Participants will receive LY3549492 orally |
| LY3549492 Dose 2 | Experimental | Drug: LY3549492Participants will receive LY3549492 orally |
| LY3549492 Dose 3 | Experimental | Drug: LY3549492Participants will receive LY3549492 orally |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive Placebo orally |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are native Chinese
- Have type 2 diabetes for at least 6 months
- Have been treated with diet and exercise, with or without a stable dose of metformin for at least 3 months
- Have hemoglobin A1c (HbA1c) of at least 7% and no greater than 10%
- Have a body mass index (BMI) of at least 20 milligrams per square meter (kg/m2) and no greater than 40 kg/m2
Key exclusion criteria (10 listed)
- Have type 1 diabetes or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization
- Have had an episode of severe hypoglycemia within 6 months or have a history of hypoglycemia unawareness
- Have a clinically significant gastric emptying abnormality
- Have or have a history of pancreatitis
- Have signs and symptoms of liver disease, with the exception of non-alcoholic fatty liver disease
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 Dose 1, LY3549492 Dose 2, LY3549492 Dose 3 |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline through Week 14
A summary of treatment emergent adverse events (TEAEs), SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module.
2 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3549492
Time frame: Predose through Week 13
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492
Time frame: Predose through Week 13
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 3 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
3 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 Type 2 Diabetes, run by Eli Lilly and Company at 3 sites in China.
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 7 inclusion and 10 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 3 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 3 sites in China. 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 Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration (time frame: Baseline through Week 14). 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 3 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.