NCT06186622CompletedPhase 1
A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants
A Drug-Drug Interaction Study to Assess the Effect of Orforglipron on the Pharmacokinetics of Digoxin, Simvastatin, Rosuvastatin, Acetaminophen, and Midazolam in Healthy Overweight and Obese Participants
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
The main purpose of this study is to determine effect of orforglipron capsule formulation on the amount of digoxin, rosuvastatin, acetaminophen, midazolam, and simvastatin (each given alone and together with orforglipron) that enters the bloodstream and how long it takes the body to eliminate them when administered orally in healthy overweight and obese participants. In addition, the effect of the orforglipron tablet on the amount of simvastatin that enters the bloodstream and how long it takes the body to eliminate it will be evaluated. The study will also assess the effect of sodium bicarbonate when administered alone with simvastatin versus orforglipron capsule containing sodium bicarbonate administered with simvastatin. The safety and tolerability of orforglipron and information about any side effects experienced will be collected. Study will be conducted in two parts, with part 1 and 2 lasting up to approximately 23 and 24 weeks each, including the screening period.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 16 Dec 2023
- Start date
- 2 Jan 2024
- Primary completion date
- 10 Jul 2024
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Obesity
- NCT number
- NCT06186622
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 50
- From 2 Jan 2024 to the primary completion date, 10 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have undergone bariatric surgery (for example: Lap-Band, Gastric Bypass)
- Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug.
Other illness
- 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 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 a known allergy or hypersensitivity to midazolam, simvastatin, rosuvastatin, or digoxin.
Lab values
- Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater.
Other
- Have known clinically significant gastric emptying abnormality.
- Have an abnormal 12-lead electrocardiogram (ECG) at screening.
- Participants must not be currently participating in or completed a clinical trial within the last 90 days.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fortrea Clinical Research Unit Inc. Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Fortrea Clinical Research Unit Inc. Coordinator of this site? Confirm its status | Daytona Beach | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.