Loading clinical trials...

A Drug-Drug Interaction Study of Orforglipron (LY3502970) in Healthy Overweight and Obese Participants | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT06186622•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Yes

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.

Locations (2)

Fortrea Clinical Research Unit Inc.

Daytona Beach, Florida, United States

Fortrea Clinical Research Unit Inc.

Dallas, Texas, United States

Key Dates

Start Date

January 2, 2024

Primary Completion Date

July 10, 2024

Completion Date

July 10, 2024

Last Updated

July 22, 2024

Enrollment

ACTUAL participants

Conditions

HealthyObeseOverweight

Interventions

Orforglipron

DRUG

Simvastatin

DRUG

Digoxin

DRUG

Rosuvastatin

DRUG

Acetaminophen

DRUG

Midazolam

DRUG

Sodium Bicarbonate

DRUG

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

NCT07472881

MenopausePerimenopause+2 more

View study

RECRUITINGNA

A New Portable Device for Non-invasive Ventilatory Support

NCT06716502

HealthyRespiratory Disease

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 22, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Multi-Acupoint Laser Therapy for Body Shape and Composition in Obese Menopausal Women

A New Portable Device for Non-invasive Ventilatory Support

Research Into the Safety of a New Agent (VT-5006) in People With and Without Parkinson's Disease

Collection of Data and Samples From Healthy Donors for Use in Translational Research

Fecal Microbiota Transplantation for Patients With Autism Spectrum Disorder.

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool