Healthy VolunteersPhase 1NCT07701083
A Study of Eloralintide (LY3841136) in Healthy Participants
A Phase 1 study testing Eloralintide in people with Healthy Volunteers, run by Eli Lilly and Company at 2 sites in United States.
Trial summary
The main purpose of this study is to learn about safety, tolerability and how well the body processes two different eloralintide solutions. Participation in this study will last about 13 weeks, including screening, inpatient treatment, and follow-up. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Eloralintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Jul 2026to Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Are overtly healthy as determined by medical evaluation
- Have a body mass index (BMI) within the range of 20.0 to 32.0 kilogram per square meter (kg/m2), inclusive
Who cannot join
- Have known allergies to related compounds of eloralintide, or any of the components of the formulations
- Have significant previous or current history of comorbidities 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 been diagnosed with Type 1 or Type 2 diabetes mellitus, or have glycated hemoglobin greater than or equal to 6.5% or 48 millimole per mole (mmol/mol)
- Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis
- Have obesity induced by other endocrinologic disorders for example, Cushing syndrome, or diagnosed monogenetic or syndromic forms of obesity for example, Melanocortin 4 Receptor deficiency or Prader Willi syndrome
- Have taken approved or investigational medication for weight loss, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), within the previous 3 months of study screening
- Intend to use any weight loss medications during study participation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Fortrea Clinical Research Unit
Dallas, Texas, 75247
Fortrea Clinical Research Unit
Daytona Beach, Florida, 32117
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Two Eloralintide Solutions in Healthy Participants
The main purpose of this study is to learn about safety, tolerability and how well the body processes two different eloralintide solutions. Participation in this study will last about 13 weeks, including screening, inpatient treatment, and follow-up.
- Conditions
- Healthy Volunteers
- Being tested
- Eloralintide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EloralintideDrug
Also called LY3841136
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Eloralintide (Reference) | Active comparator | Participants will receive eloralintide reference formulation administered subcutaneously (SC). Receives: Drug: Eloralintide |
| Eloralintide (Test) | Experimental | Participants will receive eloralintide test formulation administered SC. Receives: Drug: Eloralintide |
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 Eloralintide
Measured: Predose on Day 1 through Day 57
PK: Maximum Concentration (Cmax) of Eloralintide
Measured: Predose on Day 1 through Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start20 Jul 2026
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- 58 participants (estimated)
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
- NCT07701083
- Sponsor's protocol ID
- 27885
- Other IDs
- J3R-MC-YDAT
- Status last verified
- Sep 2026
- First submitted
- 9 Jul 2026
- Last updated
- 29 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 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Two Eloralintide Solutions in Healthy Participants
- ClinicalTrials.gov ID
- NCT07701083
- Acronym / sponsor ID
- 27885
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 14 Jul 2026 (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 learn about safety, tolerability and how well the body processes two different eloralintide solutions. Participation in this study will last about 13 weeks, including screening, inpatient treatment, and follow-up.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eloralintide (Reference) | Active comparator | Drug: EloralintideParticipants will receive eloralintide reference formulation administered subcutaneously (SC). |
| Eloralintide (Test) | Experimental | Drug: EloralintideParticipants will receive eloralintide test formulation administered SC. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Are overtly healthy as determined by medical evaluation
- Have a body mass index (BMI) within the range of 20.0 to 32.0 kilogram per square meter (kg/m2), inclusive
Key exclusion criteria (8 listed)
- Have known allergies to related compounds of eloralintide, or any of the components of the formulations
- Have significant previous or current history of comorbidities 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 been diagnosed with Type 1 or Type 2 diabetes mellitus, or have glycated hemoglobin greater than or equal to 6.5% or 48 millimole per mole (mmol/mol)
- Have a history of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- Have a history or presence of a gastrointestinal (GI) disorder or previous surgery that impacts gastric emptying for example, gastric bypass surgery or pyloric stenosis
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 |
|---|---|---|
| EloralintideAlso: LY3841136Administered SC. | Drug | Eloralintide (Reference), Eloralintide (Test) |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide
Time frame: Predose on Day 1 through Day 57
PK: Maximum Concentration (Cmax) of Eloralintide
Time frame: Predose on Day 1 through Day 57
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
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
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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
2 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 Eloralintide in people with Healthy Volunteers, run by Eli Lilly and Company at 2 sites in United States.
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 2 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 29 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 2 sites in United States. 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?
This study is still under way. Results are not available in the source record yet.
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 Eloralintide (time frame: Predose on Day 1 through Day 57). 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 29 Sep 2026.