ObesityPhase 1NCT07738614
A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight
A Phase 1 study testing Eloralintide and Acetaminophen in people with Obesity and Overweight, run by Eli Lilly and Company at 2 sites in 2 countries.
Trial summary
The main purpose of this study is to find out how significantly Eloralintide slows stomach emptying in participants who are overweight or obese. For each participant, the study will last approximately 21 weeks and will include 2 overnight stays in the clinical research unit (CRU) lasting between 4 and 8 days. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Eloralintide and Acetaminophen
- 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
- 56 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 31 Jul 2026to Dec 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
- Have overweight or obesity, but are otherwise overtly healthy.
- Have a body mass index (BMI) within the range of 27.0 to 45.0 kilograms (kg)/square meter (m²), inclusive.
- Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening.
Who cannot join
- Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have either of the following at screening
- A fasting plasma glucose concentration greater than or equal to 126 milligrams (mg)/deciliter (dL) or 7.0 millimoles (mmol)/liter (L), or
- Hemoglobin A1C (HbA1c) greater than or equal to 6.5% or 48 mmol/mole (mol).
- Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, and bipolar disorder, within the last 2 years.
- Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, or GIP/GLP-1/glucagon receptor agonist within 60 days or 5 half-lives, whichever is longer, prior to screening.
- Are in the judgment of the investigator, actively suicidal or deemed to be at significant risk for suicide.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
ICON Early Phase Services
San Antonio, Texas, 78209
210-225-5437
Chinonye Ogbonnaya-Odor
Singapore1 site, 1 recruiting
- Recruiting
Lilly Centre for Clinical Pharmacology
Singapore, 138623
+65 6413 9811
Greg Li
About this study
Official title: A Phase 1, Investigator- and Participant-Blinded, Placebo-Controlled, Randomized, Multiple-Dose Study to Evaluate the Gastric Emptying Delay, Pharmacokinetics, Safety, and Tolerability of Eloralintide in Participants With Obesity or Overweight
The main purpose of this study is to find out how significantly Eloralintide slows stomach emptying in participants who are overweight or obese. For each participant, the study will last approximately 21 weeks and will include 2 overnight stays in the clinical research unit (CRU) lasting between 4 and 8 days. There will be 13 other visits.
- Conditions
- Obesity, Overweight
- Being tested
- Eloralintide, Placebo, Acetaminophen
- Keywords
- Healthy
- Medical subject headings
- Obesity, Overweight
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
PlaceboDrug
Administered SC
AcetaminophenDrug
Administered Oral Solution
| Study group | Role | What they receive |
|---|---|---|
| Eloralintide Cohort 1 | Experimental | Eloralintide administered subcutaneously (SC) Receives: Drug: Eloralintide; Drug: Acetaminophen |
| Eloralintide Cohort 2 | Experimental | Eloralintide administered SC Receives: Drug: Eloralintide; Drug: Acetaminophen |
| Eloralintide Cohort 3 | Experimental | Eloralintide administered SC Receives: Drug: Eloralintide; Drug: Acetaminophen |
| Eloralintide Cohort 4 | Experimental | Eloralintide administered SC Receives: Drug: Eloralintide; Drug: Acetaminophen |
| Placebo | Placebo comparator | Placebo administered SC Receives: Drug: Placebo; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acetaminophen Area Under the Concentration Versus Time Curve (AUC)
Measured: Baseline to Day 65
Acetaminophen Maximum Observed Concentration (Cₘₐₓ)
Measured: Baseline to Day 65
Acetaminophen Time to Maximum Observed Drug Concentration (tₘₐₓ)
Measured: Baseline to Day 65
Secondary outcomes (2)
Eloralintide AUC
Measured: Baseline to Day 106
Eloralintide Cₘₐₓ
Measured: Baseline to Day 106
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start31 Jul 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 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
- NCT07738614
- Sponsor's protocol ID
- 27759
- Other IDs
- J3R-MC-YDAP
- Status last verified
- Aug 2026
- First submitted
- 28 Jul 2026
- Last updated
- 20 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Investigator- and Participant-Blinded, Placebo-Controlled, Randomized, Multiple-Dose Study to Evaluate the Gastric Emptying Delay, Pharmacokinetics, Safety, and Tolerability of Eloralintide in Participants With Obesity or Overweight
- ClinicalTrials.gov ID
- NCT07738614
- Acronym / sponsor ID
- 27759
- Conditions
- Obesity, Overweight
- Keywords
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 31 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 find out how significantly Eloralintide slows stomach emptying in participants who are overweight or obese. For each participant, the study will last approximately 21 weeks and will include 2 overnight stays in the clinical research unit (CRU) lasting between 4 and 8 days. There will be 13 other visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Eloralintide Cohort 1 | Experimental | Drug: Eloralintide, Drug: AcetaminophenEloralintide administered subcutaneously (SC) |
| Eloralintide Cohort 2 | Experimental | Drug: Eloralintide, Drug: AcetaminophenEloralintide administered SC |
| Eloralintide Cohort 3 | Experimental | Drug: Eloralintide, Drug: AcetaminophenEloralintide administered SC |
| Eloralintide Cohort 4 | Experimental | Drug: Eloralintide, Drug: AcetaminophenEloralintide administered SC |
| Placebo | Placebo comparator | Drug: Placebo, Drug: AcetaminophenPlacebo administered SC |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have overweight or obesity, but are otherwise overtly healthy.
- Have a body mass index (BMI) within the range of 27.0 to 45.0 kilograms (kg)/square meter (m²), inclusive.
- Have had a stable body weight, with less than 5 percent (%) change during the 3-month period prior to screening.
Key exclusion criteria (6 listed)
- Have been diagnosed with Type 1 or Type 2 diabetes mellitus, or have either of the following at screening
- Have a history or presence of psychiatric disorders, including a history of major depressive disorder or severe psychiatric disorders such as schizophrenia, and bipolar disorder, within the last 2 years.
- Have received a glucagon-like peptide-1 (GLP-1) receptor agonist, glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, or GIP/GLP-1/glucagon receptor agonist within 60 days or 5 half-lives, whichever is longer, prior to screening.
- Are in the judgment of the investigator, actively suicidal or deemed to be at significant risk for suicide.
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 Cohort 1, Eloralintide Cohort 2, Eloralintide Cohort 3, Eloralintide Cohort 4 |
| PlaceboAdministered SC | Drug | Placebo |
| AcetaminophenAdministered Oral Solution | Drug | Eloralintide Cohort 1, Eloralintide Cohort 2, Eloralintide Cohort 3, Eloralintide Cohort 4, Placebo |
Primary outcome
Acetaminophen Area Under the Concentration Versus Time Curve (AUC)
Time frame: Baseline to Day 65
Acetaminophen Maximum Observed Concentration (Cₘₐₓ)
Time frame: Baseline to Day 65
Acetaminophen Time to Maximum Observed Drug Concentration (tₘₐₓ)
Time frame: Baseline to Day 65
2 secondary outcomes
Eloralintide AUC
Time frame: Baseline to Day 106
Eloralintide Cₘₐₓ
Time frame: Baseline to Day 106
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 20 Aug 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.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Eloralintide and Acetaminophen in people with Obesity and Overweight, run by Eli Lilly and Company at 2 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 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 2 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?
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?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acetaminophen Area Under the Concentration Versus Time Curve (AUC) (time frame: Baseline to Day 65). The study lists 3 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 20 Aug 2026.