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

NCT06916065 | Completed Phase 1 FDA Drug

• 2 other identifiers: 27353J3R-MC-YDAE
• Study Type: interventional
• Target: 188
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (7)

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

  PK: AUC of Eloralintide and Tirzepatide

  Day 106 Predose to Approximately Week 26

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

  PK: Cmax of Eloralintide and Tirzepatide

  Day 106 Predose to Approximately Week 26

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

  PK: AUC of Eloralintide and Tirzepatide

  Baseline Up to Approximately Week 11

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

  PK: Cmax of Eloralintide and Tirzepatide

  Baseline Up to Approximately Week 11

• Cohorts E and F: PK: AUC of Eloralintide

  PK: AUC of Eloralintide

  Day 8 Predose Up to Approximately Week 12

• Cohorts E and F: PK: Cmax of Eloralintide

  PK: Cmax of Eloralintide

  Day 8 Predose Up to Approximately Week 12

• 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

  Baseline Up to Approximately Week 26

Study Arms (2)

Eloralintide and Tirzepatide-Cohorts A-D

EXPERIMENTAL

Eloralintide and Tirzepatide administered subcutaneously (SC)

Drug: Eloralintide and Tirzepatide

Eloralintide-Cohorts E and F

EXPERIMENTAL

Eloralintide administered SC

Drug: Eloralintide

Interventions

Eloralintide and Tirzepatide DRUG

Administered SC

Also known as: LY3841136

Eloralintide and Tirzepatide-Cohorts A-D

Eloralintide DRUG

Administered SC

Also known as: LY3841136

Eloralintide-Cohorts E and F

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (3)

Anaheim Clinical Trials, LLC

Anaheim, California, 92801, United States

Location

Fortrea Clinical Research Unit

Daytona Beach, Florida, 32117, United States

Location

Fortrea Clinical Research Unit

Dallas, Texas, 75247, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2025
• First Posted: April 8, 2025
• Study Start: April 9, 2025
• Primary Completion: January 19, 2026
• Study Completion: January 19, 2026
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)