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Completed

NCT Number: NCT06916065

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eloralintide and Tirzepatide

Drug

Administered SC

Other names: LY3841136

Eloralintide

Drug

Administered SC

Other names: LY3841136

Primary outcomes

  1. 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

  2. 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

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

    Time frame: Baseline Up to Approximately Week 11

    PK: AUC of Eloralintide and Tirzepatide

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

    Time frame: Baseline Up to Approximately Week 11

    PK: Cmax of Eloralintide and Tirzepatide

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

    Time frame: Day 8 Predose Up to Approximately Week 12

    PK: AUC of Eloralintide

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

    Time frame: Day 8 Predose Up to Approximately Week 12

    PK: Cmax of Eloralintide

  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

    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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 8, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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