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

Lilly

Status and phase

Completed

Phase 1

Conditions

Overweight

Obese

Healthy

Treatments

Drug: Sodium Bicarbonate

Drug: Orforglipron

Drug: Simvastatin

Drug: Acetaminophen

Drug: Digoxin

Drug: Rosuvastatin

Drug: Midazolam

Study type

Interventional

Funder types

Industry

Identifiers

NCT06186622

18631

J2A-MC-GZPG (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

50 participants in 2 patient groups

Orforglipron (Part 1)

Experimental group

Description:

Participants will receive Orforglipron capsule and tablet formulation with Simvastatin, Digoxin, Rosuvastatin, Acetaminophen, Midazolam and Sodium Bicarbonate administered orally.

Treatment: