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CompletedPhase 1

A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity

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

Assets

Eloralintide / Tirzepatide

Listed sites

3

Recruiting sites

Enrollment

188

actual

Study population

Obesity / overweight

Key I/E criterion

BMI 27-40

Primary endpoints

Cohorts A and BCohorts C and DCohorts E and F

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06916065
Org study ID27353
Secondary IDJ3R-MC-YDAEEli Lilly and Company

Timeline

Milestones

Study first posted2025-04-08actual
Study start2025-04-09actual
Primary completion2026-01-19actual
Study completion2026-01-19actual
Last update posted2026-01-30actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

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

Exclusion criteria

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
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

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

7 endpoints
Primary/protocol endpoint

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

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cohorts A and B: PK: Maximum Concentration (Cmax) of Eloralintide and Tirzepatide

Time frame:Day 106 Predose to Approximately Week 26

Cmax

concentration, descriptive

Primary/protocol endpoint

Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide

Time frame:Baseline Up to Approximately Week 11

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide

Time frame:Baseline Up to Approximately Week 11

Cmax

concentration, descriptive

Primary/protocol endpoint

Cohorts E and F: PK: AUC of Eloralintide

Time frame:Day 8 Predose Up to Approximately Week 12

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Cohorts E and F: PK: Cmax of Eloralintide

Time frame:Day 8 Predose Up to Approximately Week 12

Cmax

concentration, descriptive

Primary/protocol endpoint

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

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.