Current partner codePEPTIDESDE
NCT06916065·Phase 1·INTERVENTIONAL

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

Status

Completed

Phase

Phase 1

Enrollment

188

Locations

3

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Eloralintide and Tirzepatide

Administered SC

DRUG

Eloralintide

Administered SC

Timeline

From registration to results.

  1. First posted

    Apr 8, 2025

  2. Study start

    Apr 9, 2025

  3. Primary completion

    Jan 19, 2026

  4. Study completion

    Jan 19, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jan 30, 2026

Outcomes

What the study measures.

Primary outcomes

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

Secondary outcomes

Not reported in the indexed record.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
65 Years
Sex
ALL
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: * 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

Study locations

3 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Anaheim Clinical Trials, LLC

Anaheim, California, United States

Fortrea Clinical Research Unit

Daytona Beach, Florida, United States

Fortrea Clinical Research Unit

Dallas, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Eloralintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.