DRUG
Eloralintide and Tirzepatide
Administered SC
Status
Completed
Phase
Phase 1
Enrollment
188
Locations
3
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Administered SC
DRUG
Administered SC
Timeline
First posted
Apr 8, 2025
Study start
Apr 9, 2025
Primary completion
Jan 19, 2026
Study completion
Jan 19, 2026
Results posted
Not reported
Registry updated
Jan 30, 2026
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
Not reported in the indexed record.
Eligibility
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
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
No PMID-linked publications were present in this registry snapshot.
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