HealthyPhase 1NCT06945419
A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes
A Phase 1 study testing LY4086940 in people with Healthy and Overweight, run by Eli Lilly and Company at 5 sites in 2 countries.
Trial summary
The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body. Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 10 visits. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Overweight, Obesity
- What is being tested?
- LY4086940
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 219 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 23 Apr 2025to 5 Aug 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have no significant body weight change for the 3 months prior to screening
- Part A and Part E:
- Are considered healthy
- Have a body mass index (BMI) of 22 to 35 kilograms per square meter (kg/m2) at screening
- Part B:
- Have a BMI of 27 to 45 kg/m2 at screening
Show all 12Show fewer
- Part C:
- Have a BMI of 25 to 45 kg/m2 at screening
- Part D:
- Have type 2 diabetes
- Have hemoglobin A1C (HbA1c) ≥6.5% and ≤10.5% at screening
- Have a BMI of 27 to 45 kg/m2 at screening
Who cannot join
- Have had an acute cardiovascular condition within the past 6 months prior to screening
- Have liver disease or pancreatitis
- Have used medications for weight loss within the 3 months prior to screening
- Parts A, B, C, E:
- Have any form of diabetes
- Part D:
- Have type 1 diabetes
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
Clinical Pharmacology of Miami
Miami, Florida, 33172
Endeavor Clinical Trials
San Antonio, Texas, 78240
About this study
Official title: A Single-Dose and Multiple-Ascending Dose Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes
The main purpose of this study is to evaluate the safety, tolerability of LY4086940 and how it is processed in the body.
Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 10 visits. Participation in Part E will last approximately 7 weeks and may include up to 12 visits.
- Conditions
- Healthy, Overweight, Obesity, Type 2 Diabetes
- Being tested
- LY4086940, Placebo
- Keywords
- Oral, Incretin, Weight loss, Overweight, Obesity, Diabetes
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2, Weight Loss, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4086940Drug
Administered orally
PlaceboDrug
Administered orally
LY4086940Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY4086940 Single Dose (Healthy Participants) | Experimental | Participants will receive a single dose of LY4086940 orally Receives: Drug: LY4086940 |
| Part A: Placebo Single Dose (Healthy Participants) | Placebo comparator | Participants will receive a single dose of placebo orally Receives: Drug: Placebo |
| Part A: LY4086940 Multiple Dose (Healthy Participants) | Experimental | Participants will receive LY4086940 orally for 3 days Receives: Drug: LY4086940 |
| Part A: Placebo Multiple Dose (Healthy Participants) | Placebo comparator | Participants will receive placebo orally for 3 days Receives: Drug: Placebo |
| Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity) | Experimental | Participants will receive LY4086940 orally for 4 weeks Receives: Drug: LY4086940 |
| Part B: Placebo Multiple Dose (Participants with Overweight or Obesity) | Placebo comparator | Participants will receive placebo orally for 4 weeks Receives: Drug: Placebo |
| Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity) | Experimental | Participants will receive LY4086940 orally for 4 weeks Receives: Drug: LY4086940 |
| Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity | Placebo comparator | Participants will receive placebo orally for 4 weeks Receives: Drug: Placebo |
| Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) | Experimental | Participants will receive LY4086940 orally for 4-6 weeks Receives: Drug: LY4086940 |
| Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) | Placebo comparator | Participants will receive placebo orally for 4-6 weeks Receives: Drug: Placebo |
| Part E (Open-Label): LY4086940 Single Dose (Healthy Participants) | Experimental | Participants will receive a single dose of LY4086940 intravenously (IV) Receives: Drug: LY4086940 |
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
Measured: Baseline up to Week 9
Secondary outcomes (2)
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4086940
Measured: Predose up to Day 64
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4086940
Measured: Predose up to Day 64
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start23 Apr 2025
- Primary completion5 Aug 2026
- Study completion5 Aug 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
- 219 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
- NCT06945419
- Sponsor's protocol ID
- 27267
- Other IDs
- J5U-MC-YGAA
- Status last verified
- Aug 2026
- First submitted
- 18 Apr 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Dose and Multiple-Ascending Dose Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06945419
- Acronym / sponsor ID
- 27267
- Conditions
- Healthy, Overweight, Obesity, Type 2 Diabetes
- Keywords
- Oral, Incretin, Weight loss, Overweight, Obesity, Diabetes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 5 Aug 2026 (actual)
- Study completion
- 5 Aug 2026 (actual)
- First posted
- 25 Apr 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 evaluate the safety, tolerability of LY4086940 and how it is processed in the body.
Participation in Part A of the study will last about 10 weeks and may include up to 6 visits. Participation in Parts B, C, D will last approximately 15 weeks and may include up to 10 visits. Participation in Part E will last approximately 7 weeks and may include up to 12 visits.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part A: LY4086940 Single Dose (Healthy Participants) | Experimental | Drug: LY4086940Participants will receive a single dose of LY4086940 orally |
| Part A: Placebo Single Dose (Healthy Participants) | Placebo comparator | Drug: PlaceboParticipants will receive a single dose of placebo orally |
| Part A: LY4086940 Multiple Dose (Healthy Participants) | Experimental | Drug: LY4086940Participants will receive LY4086940 orally for 3 days |
| Part A: Placebo Multiple Dose (Healthy Participants) | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally for 3 days |
| Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity) | Experimental | Drug: LY4086940Participants will receive LY4086940 orally for 4 weeks |
| Part B: Placebo Multiple Dose (Participants with Overweight or Obesity) | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally for 4 weeks |
| Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity) | Experimental | Drug: LY4086940Participants will receive LY4086940 orally for 4 weeks |
| Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally for 4 weeks |
| Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) | Experimental | Drug: LY4086940Participants will receive LY4086940 orally for 4-6 weeks |
| Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) | Placebo comparator | Drug: PlaceboParticipants will receive placebo orally for 4-6 weeks |
| Part E (Open-Label): LY4086940 Single Dose (Healthy Participants) | Experimental | Drug: LY4086940Participants will receive a single dose of LY4086940 intravenously (IV) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have no significant body weight change for the 3 months prior to screening
- Are considered healthy
- Have a body mass index (BMI) of 22 to 35 kilograms per square meter (kg/m2) at screening
- Have a BMI of 27 to 45 kg/m2 at screening
- Have a BMI of 25 to 45 kg/m2 at screening
Key exclusion criteria (7 listed)
- Have had an acute cardiovascular condition within the past 6 months prior to screening
- Have liver disease or pancreatitis
- Have used medications for weight loss within the 3 months prior to screening
- Have any form of diabetes
- Have type 1 diabetes
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 |
|---|---|---|
| LY4086940Administered orally | Drug | Part A: LY4086940 Multiple Dose (Healthy Participants), Part A: LY4086940 Single Dose (Healthy Participants), Part B: LY4086940 Multiple Dose (Participants with Overweight or Obesity), Part C: LY4086940 Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity), Part D: LY4086940 Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) |
| PlaceboAdministered orally | Drug | Part A: Placebo Multiple Dose (Healthy Participants), Part A: Placebo Single Dose (Healthy Participants), Part B: Placebo Multiple Dose (Participants with Overweight or Obesity), Part C: Placebo Multiple Dose (Japanese/Chinese Participants with Overweight or Obesity, Part D: Placebo Multiple Dose (Participants with Type 2 Diabetes with Overweight or Obesity) |
| LY4086940Administered IV | Drug | Part E (Open-Label): LY4086940 Single Dose (Healthy Participants) |
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 up to Week 9
2 secondary outcomes
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY4086940
Time frame: Predose up to Day 64
PK: Area Under the Concentration Versus Time Curve (AUC) of LY4086940
Time frame: Predose up to Day 64
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 19 Aug 2026.
- A Study of LY4086940 in Healthy Participants and Participants With Overweight or Obesity, With or Without Type 2 DiabetesLink 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 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4086940 in people with Healthy and Overweight, run by Eli Lilly and Company at 5 sites in 2 countries.
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 12 inclusion and 7 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 19 Aug 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 United States, Singapore. 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 up to Week 9). 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 19 Aug 2026.