New Weight-Loss Drug's effect on other medications tested in healthy volunteers
NCT ID NCT06186622
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 1 study looked at how orforglipron, an experimental drug, changes the way the body processes several common medications (digoxin, simvastatin, rosuvastatin, acetaminophen, and midazolam) in 50 healthy overweight or obese adults. The goal was to measure drug levels in the blood, not to treat any disease. Participants took each medication alone and then with orforglipron to see if there were differences. The study provides important safety information for future use of orforglipron.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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50 people
The number who actually took part.
- Started
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Jan 2024
- Finished
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Jul 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants who are overtly healthy as determined by medical history and physical examination. * Have body mass index (BMI) equal to or greater than 27 kilograms per meter squared (kg/m²), inclusive, at screening. * Have an estimated glomerular filtration rate equal to or greater than 60 milliliters per minute (mL/min). * Males and females who agree to follow contraceptive requirements, or women not of childbearing potential (WNOCBP). * Have venous access sufficient to allow for blood sampling. Exclusion Criteria: * Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater. * Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years. * Obesity induced by other endocrine disorders, such as Cushing's syndrome or Prader-Willi syndrome. * Have known clinically significant gastric emptying abnormality. * Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass) * Have a known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or any form of thyroid cancer. * Have an abnormal 12-lead electrocardiogram (ECG) at screening. * Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug. * Participants must not be currently participating in or completed a clinical trial within the last 90 days. * Have a known allergy or hypersensitivity to midazolam, simvastatin, rosuvastatin, or digoxin.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fortrea Clinical Research Unit Inc.
Daytona Beach, Florida, 32117, United States
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Fortrea Clinical Research Unit Inc.
Dallas, Texas, 75247, United States
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