OverweightPhase 1NCT06916065
A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity
A Phase 1 study testing Eloralintide and Tirzepatide and Eloralintide in people with Overweight and Obesity, run by Eli Lilly and Company at 3 sites in United States.
Trial summary
The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Eloralintide and Tirzepatide and Eloralintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 3 sitesUnited States
- Study dates
- 9 Apr 2025to 19 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
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Participants with a history of thyroid disease or on thyroid medication will need to be biochemically euthyroid as assessed by measuring thyroid stimulating hormone at screening
- Have a body mass index (BMI) within the range of 27.0 to 40.0 kilogram per square meter (kg/m²), inclusive
- Have had a stable weight for the 3 months prior to screening, that is, less than 5% body weight change
Who cannot join
- Have known allergies to related compounds of eloralintide or tirzepatide, 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
Show all 16Show fewer
- Have a history of hypocalcemia or hypercalcemia, or abnormal laboratory values for calcium or serum phosphorus
- Have a medical history or current evidence of clinically significant cardiac condition, as per the investigator, including:
- second or third degree heart block
- sick sinus syndrome
- peripheral arterial circulatory disorders
- valvular disease
- cardiomyopathy, or
- other clinically significant cardiac condition
- Have taken approved or investigational medication for weight loss, including 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
3 sites in 1 country.
United States3 sites
Anaheim Clinical Trials, LLC
Anaheim, California, 92801
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, Single and Multiple Dose Study to Investigate the Safety, Tolerability, and Relative Bioavailability of Single and Multiple Weekly Subcutaneous Doses of Eloralintide, and Single and Multiple Weekly Subcutaneous Doses of Eloralintide With Tirzepatide in Participants With Overweight or Obesity
The purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it.
There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts E and F.
- Conditions
- Overweight, Obesity
- Being tested
- Eloralintide and Tirzepatide, Eloralintide
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eloralintide and TirzepatideDrug
Also called LY3841136
Administered SC
EloralintideDrug
Also called LY3841136
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Eloralintide and Tirzepatide-Cohorts A-D | Experimental | Eloralintide and Tirzepatide administered subcutaneously (SC) Receives: Drug: Eloralintide and Tirzepatide |
| Eloralintide-Cohorts E and F | Experimental | Eloralintide administered SC Receives: Drug: Eloralintide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide
PK: AUC of Eloralintide and Tirzepatide
Measured: Day 106 Predose to Approximately Week 26
Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide
PK: Cmax of Eloralintide and Tirzepatide
Measured: Day 106 Predose to Approximately Week 26
Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide
PK: AUC of Eloralintide and Tirzepatide
Measured: Baseline Up to Approximately Week 11
Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide
PK: Cmax of Eloralintide and Tirzepatide
Measured: Baseline Up to Approximately Week 11
Cohorts E and F: PK: AUC of Eloralintide
PK: AUC of Eloralintide
Measured: Day 8 Predose Up to Approximately Week 12
Cohorts E and F: PK: Cmax of Eloralintide
PK: Cmax of Eloralintide
Measured: Day 8 Predose Up to Approximately Week 12
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline Up to Approximately Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start9 Apr 2025
- Primary completion19 Jan 2026
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 188 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
- NCT06916065
- Sponsor's protocol ID
- 27353
- Other IDs
- J3R-MC-YDAE
- Status last verified
- Jan 2026
- First submitted
- 1 Apr 2025
- Last updated
- 30 Jan 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 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Single and Multiple Dose Study to Investigate the Safety, Tolerability, and Relative Bioavailability of Single and Multiple Weekly Subcutaneous Doses of Eloralintide, and Single and Multiple Weekly Subcutaneous Doses of Eloralintide With Tirzepatide in Participants With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06916065
- Acronym / sponsor ID
- 27353
- Conditions
- Overweight, Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 9 Apr 2025 (actual)
- Primary completion
- 19 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 8 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 purpose of this study is to evaluate how well eloralintide and eloralintide with tirzepatide is tolerated and what side effects may occur in participants with overweight or obesity. The study drug will be administered subcutaneously (SC) (under the skin). Blood tests will be performed to check how much eloralintide and eloralintide with tirzepatide get into the bloodstream and how long it takes the body to eliminate it.
There will be 6 cohorts. The study will last up to approximately 26 weeks, excluding screening for Cohorts A and B, 11 weeks for Cohorts C and D, and 12 weeks for Cohorts E and F.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eloralintide and Tirzepatide-Cohorts A-D | Experimental | Drug: Eloralintide and TirzepatideEloralintide and Tirzepatide administered subcutaneously (SC) |
| Eloralintide-Cohorts E and F | Experimental | Drug: EloralintideEloralintide administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Participants with a history of thyroid disease or on thyroid medication will need to be biochemically euthyroid as assessed by measuring thyroid stimulating hormone at screening
- Have a body mass index (BMI) within the range of 27.0 to 40.0 kilogram per square meter (kg/m²), inclusive
- Have had a stable weight for the 3 months prior to screening, that is, less than 5% body weight change
Key exclusion criteria (16 listed)
- Have known allergies to related compounds of eloralintide or tirzepatide, 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 |
|---|---|---|
| Eloralintide and TirzepatideAlso: LY3841136Administered SC | Drug | Eloralintide and Tirzepatide-Cohorts A-D |
| EloralintideAlso: LY3841136Administered SC | Drug | Eloralintide-Cohorts E and F |
Primary outcome
Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide
Time frame: Day 106 Predose to Approximately Week 26
PK: AUC of Eloralintide and Tirzepatide
Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide
Time frame: Day 106 Predose to Approximately Week 26
PK: Cmax of Eloralintide and Tirzepatide
Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide
Time frame: Baseline Up to Approximately Week 11
PK: AUC of Eloralintide and Tirzepatide
Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide
Time frame: Baseline Up to Approximately Week 11
PK: Cmax of Eloralintide and Tirzepatide
Cohorts E and F: PK: AUC of Eloralintide
Time frame: Day 8 Predose Up to Approximately Week 12
PK: AUC of Eloralintide
Cohorts E and F: PK: Cmax of Eloralintide
Time frame: Day 8 Predose Up to Approximately Week 12
PK: Cmax of Eloralintide
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time frame: Baseline Up to Approximately Week 26
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
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 30 Jan 2026.
- Related InfoLink 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
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 Eloralintide and Tirzepatide and Eloralintide in people with Overweight and Obesity, run by Eli Lilly and Company at 3 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 3 inclusion and 16 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 30 Jan 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. 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?
Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide (time frame: Day 106 Predose to Approximately Week 26). The study lists 7 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 30 Jan 2026.