Overweight or ObesityPhase 1YHAANCT07152002
A Study of LY4064912 in Healthy Participants and With Overweight or Obesity
A Phase 1 study testing LY4064912 in people with Overweight or Obesity and Healthy, run by Eli Lilly and Company at 3 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and participants with overweight and obesity - global. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight or Obesity, Healthy
- What is being tested?
- LY4064912
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 28 Aug 2025to 26 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
- Age is 21-65 years old at Singapore Sites
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Part A: Body Mass Index (BMI) within the range greater than or equal to 21 and less than 30 kilogram per square meter (kg/m²)
- Part B: a BMI greater than or equal to 27 and less than 45 kg/m²
- Part C: a BMI greater than or equal to 21 and less than 35 kg/m²
- Parts A and C: Participants must weigh 60 kilograms (kg) or more at screening
- Have had a less than 5% change in body weight for 3 months before screening
- Safety laboratory tests are within normal reference range
Who cannot join
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have HbA1c greater than or equal to 6.5% (48 millimole per mole (mmol/mol)) at screening
- Are individuals of childbearing potential (IOCBP).
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
United States2 sites
Collaborative Neuroscience Network - CNS
Los Alamitos, California, 90720
ICON Early Phase Services
San Antonio, Texas, 78209
About this study
Official title: A Phase 1, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4064912 in Healthy Participants and Participants With Overweight or Obesity
The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and participants with overweight and obesity - global. The study drug will be administered either subcutaneously (SC) (under the skin) or infusion intravenously (IV) (into a vein in the arm).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
- Conditions
- Overweight or Obesity, Healthy
- Being tested
- LY4064912, Placebo
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4064912Drug
Administered SC
LY4064912Drug
Administered IV
PlaceboDrug
Administered SC
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Part A: LY4064912 (Cohorts 1-6) | Experimental | LY4064912 administered subcutaneously (SC) Receives: Drug: LY4064912 |
| Part A: LY4064912 (Cohort 6a) | Experimental | LY4064912 administered intravenously (IV) Receives: Drug: LY4064912 |
| Part A: Placebo | Placebo comparator | Placebo administered SC and IV Receives: Drug: Placebo |
| Part B: LY4064912 (Cohorts 7-10) | Experimental | LY4064912 administered SC Receives: Drug: LY4064912 |
| Part B: Placebo | Placebo comparator | Placebo administered SC Receives: Drug: Placebo |
| Part C: LY4064912 (Cohort 11) | Experimental | LY4064912 administered SC Receives: Drug: LY4064912 |
| Part C: Placebo | Experimental | Placebo administered SC 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 Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Postdose to Approximately Week 27
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4064912
PK: AUC of LY4064912
Measured: Predose Up to Day 78
PK: Maximum Concentration (Cmax) of LY4064912
PK: Cmax of LY4064912
Measured: Predose Up to Day 78
Change from Baseline in Body Weight
Change from Baseline in Body Weight
Measured: Baseline to Approximately Week 27
Effects of LY4064912 on Renal Hemodynamics and Renal Function
Glomerular Filtration Rate (GFR)
Measured: Baseline Up to Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2025
- Study start28 Aug 2025
- Primary completion26 Aug 2026
- Study completion26 Aug 2026
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overweight or ObesityStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 77 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
- NCT07152002
- Sponsor's protocol ID
- 27192
- Other IDs
- J5L-MC-YHAA
- Acronym
- YHAA
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2025
- Last updated
- 14 Sep 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 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY4064912 in Healthy Participants and Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT07152002
- Acronym / sponsor ID
- YHAA / 27192
- Conditions
- Overweight or Obesity, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 28 Aug 2025 (actual)
- Primary completion
- 26 Aug 2026 (actual)
- Study completion
- 26 Aug 2026 (actual)
- First posted
- 3 Sep 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 LY4064912 is tolerated and what side effects may occur in healthy participants and participants with overweight and obesity - global. The study drug will be administered either subcutaneously (SC) (under the skin) or infusion intravenously (IV) (into a vein in the arm).
Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A: LY4064912 (Cohorts 1-6) | Experimental | Drug: LY4064912LY4064912 administered subcutaneously (SC) |
| Part A: LY4064912 (Cohort 6a) | Experimental | Drug: LY4064912LY4064912 administered intravenously (IV) |
| Part A: Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC and IV |
| Part B: LY4064912 (Cohorts 7-10) | Experimental | Drug: LY4064912LY4064912 administered SC |
| Part B: Placebo | Placebo comparator | Drug: PlaceboPlacebo administered SC |
| Part C: LY4064912 (Cohort 11) | Experimental | Drug: LY4064912LY4064912 administered SC |
| Part C: Placebo | Experimental | Drug: PlaceboPlacebo administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age is 21-65 years old at Singapore Sites
- Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
- Part A: Body Mass Index (BMI) within the range greater than or equal to 21 and less than 30 kilogram per square meter (kg/m²)
- Part B: a BMI greater than or equal to 27 and less than 45 kg/m²
- Part C: a BMI greater than or equal to 21 and less than 35 kg/m²
Key exclusion criteria (3 listed)
- Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
- Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes (any form), or have HbA1c greater than or equal to 6.5% (48 millimole per mole (mmol/mol)) at screening
- Are individuals of childbearing potential (IOCBP).
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 |
|---|---|---|
| LY4064912Administered SC | Drug | Part A: LY4064912 (Cohorts 1-6), Part B: LY4064912 (Cohorts 7-10), Part C: LY4064912 (Cohort 11) |
| LY4064912Administered IV | Drug | Part A: LY4064912 (Cohort 6a) |
| PlaceboAdministered SC | Drug | Part A: Placebo, Part B: Placebo, Part C: Placebo |
| PlaceboAdministered IV | Drug | Part A: Placebo |
Primary outcome
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Postdose to Approximately Week 27
A summary of 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 LY4064912
Time frame: Predose Up to Day 78
PK: Maximum Concentration (Cmax) of LY4064912
Time frame: Predose Up to Day 78
Change from Baseline in Body Weight
Time frame: Baseline to Approximately Week 27
Effects of LY4064912 on Renal Hemodynamics and Renal Function
Time frame: Baseline Up to Day 31
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY4064912 in people with Overweight or Obesity and Healthy, run by Eli Lilly and Company at 3 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 8 inclusion and 3 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: stopped early, as of the sponsor's last update on 14 Sep 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 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 was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
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 Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration (time frame: Postdose to Approximately Week 27). 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 14 Sep 2026.