Evaluating eloralintide and tirzepatide for overweight and obesity
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
This study is testing if the combination of two medications, eloralintide and tirzepatide, is safe and effective for people who are overweight or obese.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 188 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 3 sites (Anaheim, California and 2 other locations) |
| Trial ID | NCT06916065 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of eloralintide alone and in combination with tirzepatide in participants who are overweight or obese. The investigational drugs will be administered subcutaneously, and blood tests will be conducted to measure the absorption and elimination of the drugs from the body. The study will consist of six cohorts and will last approximately 26 weeks, with varying durations for different cohorts. Participants will be monitored for side effects and overall health during the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with a body mass index (BMI) between 27.0 and 40.0 kg/m² who have maintained a stable weight for the past three months.
Not a fit: Patients with known allergies to eloralintide or tirzepatide, or those with significant comorbidities affecting drug metabolism, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide new treatment options for individuals struggling with overweight and obesity.
How similar studies have performed: Other studies have shown promise with similar approaches to treating obesity, but this specific combination is being evaluated for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
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 and enrollment, 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
Where this trial is running
Anaheim, California and 2 other locations
- Anaheim Clinical Trials, LLC — Anaheim, California, United States (Recruiting)
- Fortrea Clinical Research Unit — Daytona Beach, Florida, United States (Recruiting)
- Fortrea Clinical Research Unit — Dallas, Texas, United States (Recruiting)
Study contacts
- Study coordinator: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Email: clinical_inquiry_hub@lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.