A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants

Completed · Phase 1

Conditions studied: Healthy, Obese, Overweight

In brief

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.

Key facts

Study ID

NCT06186622

Run by

Eli Lilly and Company

People needed

50

Starts

2024-01-02

Expected to finish

2024-07-10

Last updated by the study team

2026-05-22

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Fortrea Clinical Research Unit Inc. — Daytona Beach, Florida, United States
• Fortrea Clinical Research Unit Inc. — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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