HealthyPhase 1NCT07202871
A Study of How the Body Absorbs LY3537031
A Phase 1 study testing LY3537031 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
Trial summary
The main purpose of this study is to find out how much LY3537031 gets into the blood stream and how long it takes the body to get rid of it when it is injected just under the skin in different parts of the body, and when it is injected into a vein, in healthy participants. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- LY3537031
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteSingapore
- Study dates
- 3 Nov 2025to 17 Jul 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 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are overtly healthy as determined by medical evaluation including medical history and physical examination.
- Have a body weight of at least 45 kg.
- Have a Body Mass Index (BMI) within the range of 18.5 and 35.0 kg/m², inclusive
- Do not have skin aberrations that would preclude administration of the study drug at the planned injection sites.
Who cannot join
- Have significant history or current cardiovascular, respiratory, hepatic, renal, Gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe post treatment hypersensitivity reactions, or have known allergies to LY3537031, Glucagon-Like Peptide-1 (GLP-1) analogs, or related compounds.
- Have undergone any form of bariatric surgery.
- Have a diagnosis or history of malignant disease within 5 years before screening, with the following (some exceptions are allowed)
- Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× Upper Limit of Normal (ULN).
- Have a history of chronic liver disease, acute or chronic hepatitis, including a history of autoimmune hepatitis, or any evidence for hepatic impairment.
- Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, 2-Part Study to Determine the Effect of Injection Site on the Relative Bioavailability of a Single Subcutaneous Dose of LY3537031 and to Evaluate the Pharmacokinetics of a Single Intravenous Dose of LY3537031 in Healthy Participants
The main purpose of this study is to find out how much LY3537031 gets into the blood stream and how long it takes the body to get rid of it when it is injected just under the skin in different parts of the body, and when it is injected into a vein, in healthy participants. This study will also look at the safety and tolerability of LY3537031.
- Conditions
- Healthy
- Being tested
- LY3537031
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3537031Drug
Administered SC
LY3537031Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| LY3537031 - Part A | Experimental | LY3537031 administered Subcutaneously (SC) in three different injection sites Receives: Drug: LY3537031 |
| LY3537031 - Part B | Experimental | LY3537031 administered Intravenously (IV) Receives: Drug: LY3537031 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3537031
PK: AUC of LY3537031
Measured: Day 1 Predose up to Day 64
Pharmacokinetics (PK): Maximum Serum Observed Drug Concentration (Cmax) of LY3537031
PK: Cmax of LY3537031
Measured: Day 1 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 posted2 Oct 2025
- Study start3 Nov 2025
- Primary completion17 Jul 2026
- Study completion17 Jul 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
- None (open label)
- Enrolment
- 47 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
- NCT07202871
- Sponsor's protocol ID
- 27394
- Other IDs
- J2S-MC-GZMN
- Status last verified
- Jul 2026
- First submitted
- 24 Sep 2025
- Last updated
- 23 Jul 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 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, 2-Part Study to Determine the Effect of Injection Site on the Relative Bioavailability of a Single Subcutaneous Dose of LY3537031 and to Evaluate the Pharmacokinetics of a Single Intravenous Dose of LY3537031 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07202871
- Acronym / sponsor ID
- 27394
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Nov 2025 (actual)
- Primary completion
- 17 Jul 2026 (actual)
- Study completion
- 17 Jul 2026 (actual)
- First posted
- 2 Oct 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 find out how much LY3537031 gets into the blood stream and how long it takes the body to get rid of it when it is injected just under the skin in different parts of the body, and when it is injected into a vein, in healthy participants. This study will also look at the safety and tolerability of LY3537031.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LY3537031 - Part A | Experimental | Drug: LY3537031LY3537031 administered Subcutaneously (SC) in three different injection sites |
| LY3537031 - Part B | Experimental | Drug: LY3537031LY3537031 administered Intravenously (IV) |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Are overtly healthy as determined by medical evaluation including medical history and physical examination.
- Have a body weight of at least 45 kg.
- Have a Body Mass Index (BMI) within the range of 18.5 and 35.0 kg/m², inclusive
- Do not have skin aberrations that would preclude administration of the study drug at the planned injection sites.
Key exclusion criteria (7 listed)
- Have significant history or current cardiovascular, respiratory, hepatic, renal, Gastrointestinal (GI), endocrine, hematological, dermatological, or neurological disorders that, in the opinion of the investigator, are capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data.
- Have a history of atopy; that is, severe or multiple allergic manifestations, or clinically significant multiple or severe drug allergies, or hyperesthesia, or severe post treatment hypersensitivity reactions, or have known allergies to LY3537031, Glucagon-Like Peptide-1 (GLP-1) analogs, or related compounds.
- Have undergone any form of bariatric surgery.
- Have a diagnosis or history of malignant disease within 5 years before screening, with the following (some exceptions are allowed)
- Have a history of or current acute or chronic pancreatitis, or elevation in serum lipase or amylase or both greater than 1.5× 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 |
|---|---|---|
| LY3537031Administered SC | Drug | LY3537031 - Part A |
| LY3537031Administered IV | Drug | LY3537031 - Part B |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3537031
Time frame: Day 1 Predose up to Day 64
PK: AUC of LY3537031
Pharmacokinetics (PK): Maximum Serum Observed Drug Concentration (Cmax) of LY3537031
Time frame: Day 1 Predose up to Day 64
PK: Cmax of LY3537031
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 23 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3537031 in people with Healthy, run by Eli Lilly and Company at 1 site in Singapore.
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 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 23 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 1 site in 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. 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?
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3537031 (time frame: Day 1 Predose up to Day 64). The study lists 2 primary outcomes in all. 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 23 Jul 2026.