A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity
- 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.
- Short title
- A Study of Eloralintide (LY3841136) and Eloralintide With Tirzepatide in Participants With Overweight or Obesity
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-01-19
- First posted
- 2025-04-08
- Registry last updated
- 2026-01-30
- Primary completion date
- 2026-01-19
- Start date
- 2025-04-09
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Eli Lilly and Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06916065
- ClinicalTrials.gov ID
- NCT06916065
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Basic science
- Masking
- No masking
Cohorts A and B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide and Tirzepatide
Timeframe: 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
Timeframe: Day 106 Predose to Approximately Week 26
PK: Cmax of Eloralintide and Tirzepatide
Cohorts C and D: PK: AUC of Eloralintide and Tirzepatide
Timeframe: Baseline Up to Approximately Week 11
PK: AUC of Eloralintide and Tirzepatide
Cohorts C and D: PK: Cmax of Eloralintide and Tirzepatide
Timeframe: Baseline Up to Approximately Week 11
PK: Cmax of Eloralintide and Tirzepatide
Cohorts E and F: PK: AUC of Eloralintide
Timeframe: Day 8 Predose Up to Approximately Week 12
PK: AUC of Eloralintide
Cohorts E and F: PK: Cmax of Eloralintide
Timeframe: 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
Timeframe: Baseline Up to Approximately Week 26
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Healthy volunteers
- No
- 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
-
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
- Anaheim Clinical Trials, LLCAnaheim, United States
- Fortrea Clinical Research UnitDaytona Beach, United States
- Fortrea Clinical Research UnitDallas, United States
- Related resource (trials.lilly.com)
Other registry identifiers
- J3R-MC-YDAE