GLP-1 Peptide Atlas, by Delfa

CompletedPhase 1

A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants

A Multiple Dose Study to Assess the Pharmacokinetics, Safety, and Tolerability of Tablet and Capsule Formulations of LY3502970 in Healthy Overweight and Obese Participants

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Obesity / overweight

Key I/E criterion

•Healthy volunteers

Primary endpoints

•AUC•PK: Maximum Observed Concentration (Cmax) of LY3502970•PK: Time to Maximum Observed Concentration (Tmax) of LY3502970

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05841238

Org study ID18527

Secondary IDJ2A-MC-GZGNEli Lilly and Company

Timeline

Milestones

Study start2023-04-26actual

Study first posted2023-05-03actual

Primary completion2023-09-14actual

Study completion2023-11-13actual

Last update posted2024-10-02actual

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Healthy volunteersObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Male or female participants who are overtly healthy as determined by medical evaluation

•Participants with body mass index (BMI) of 27.0 kilograms per meter squared (kg/m²) or more

•Participants with a stable body weight, with 5% or less body weight gain or loss

Exclusion criteria

•Have any type of diabetes with hemoglobin A1c (HbA1c) level of 6.5% or greater or a fasting blood sugar over 120 milligram per deciliter (mg/dL)

•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)

•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 significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drug

•Have significant history of or currently have Major Depressive Disorder or psychiatric disorder within the last 2 years

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970