A Study of Eloralintide (LY3841136) in Healthy Participants
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Eloralintide.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Two Eloralintide Solutions in Healthy Participants
Overview
The main purpose of this study is to learn about safety, tolerability and how well the body processes two different eloralintide solutions. Participation in this study will last about 13 weeks, including screening, inpatient treatment, and follow-up.
Interventions
- Drug Eloralintide
Administered SC.
Primary outcome measures
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Eloralintide [Time frame: Predose on Day 1 through Day 57]
- PK: Maximum Concentration (Cmax) of Eloralintide [Time frame: Predose on Day 1 through Day 57]
Eligibility criteria
Inclusion criteria
- Are overtly healthy as determined by medical evaluation
- Have a body mass index (BMI) within the range of 20.0 to 32.0 kilogram per square meter (kg/m2), inclusive
Exclusion criteria
- Have known allergies to related compounds of eloralintide, 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 taken approved or investigational medication for weight loss, including glucagon-like peptide-1 receptor agonists (GLP-1 RAs), within the previous 3 months of study screening
- Intend to use any weight loss medications during study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Fortrea Clinical Research Unit — Daytona Beach
- Fortrea Clinical Research Unit — Dallas
Identifiers
NCT: NCT07701083 · 27885 · J3R-MC-YDAT