CClinicalTrials.gg
CompletedNCT06916065Updated Jan 30, 2026

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

A Phase 1 interventional study of Eloralintide and Tirzepatide and Eloralintide in Overweight and Obesity, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-30.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase
Phase 1
Study type
Interventional
Enrollment
188
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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). 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.

02

Conditions studied

  • Overweight
  • Obesity
03

In context

Overweight

3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.

This study's enrollment of 188 is above the median of 73 across 3,175 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
188 participants (actual)

Study arms

  • Experimental
    Eloralintide and Tirzepatide-Cohorts A-D

    Eloralintide and Tirzepatide administered subcutaneously (SC)

    Drug: Eloralintide and Tirzepatide

  • Experimental
    Eloralintide-Cohorts E and F

    Eloralintide administered SC

    Drug: Eloralintide

Interventions

  • DrugEloralintide and Tirzepatide

    Administered SC

    Also known as: LY3841136

  • DrugEloralintide

    Administered SC

    Also known as: LY3841136

06

What researchers measure

Primary outcomes

  1. Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide

    PK: AUC of Eloralintide and Tirzepatide

    Time frame: Day 106 Predose to Approximately Week 26

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

    PK: Cmax of Eloralintide and Tirzepatide

    Time frame: Day 106 Predose to Approximately Week 26

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

    PK: AUC of Eloralintide and Tirzepatide

    Time frame: Baseline Up to Approximately Week 11

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

    PK: Cmax of Eloralintide and Tirzepatide

    Time frame: Baseline Up to Approximately Week 11

  5. Cohorts E and F: PK: AUC of Eloralintide

    PK: AUC of Eloralintide

    Time frame: Day 8 Predose Up to Approximately Week 12

  6. Cohorts E and F: PK: Cmax of Eloralintide

    PK: Cmax of Eloralintide

    Time frame: Day 8 Predose Up to Approximately Week 12

  7. 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

    Time frame: Baseline Up to Approximately Week 26

07

Study locations

3 sites
  • Anaheim Clinical Trials, LLC
    Anaheim, California 92801, United States
  • Fortrea Clinical Research Unit
    Daytona Beach, Florida 32117, United States
  • Fortrea Clinical Research Unit
    Dallas, Texas 75247, United States
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06916065
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Apr 8, 2025
Start date
Apr 9, 2025
Primary completion
Jan 19, 2026
Completion
Jan 19, 2026
Last update
Jan 30, 2026

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion