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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05841238
• Other study ID #: 18527
• Secondary ID: J2A-MC-GZGN
• Status: Completed
• Phase: Phase 1
• Start date: April 26, 2023
• Est. completion date: October 11, 2023

Study information

• Verified date: October 2023
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to evaluate how much LY3502970 gets into the bloodstream and how long it takes the body to eliminate when administered orally as tablet and capsule formulations along with effect of food on LY3502970 in healthy overweight and obese participants. The study will also evaluate the safety and tolerability of LY3502970 in these participants. The study is conducted in two parts (part A and B) and will last up to 135 days including the screening period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 11, 2023
• Est. primary completion date: September 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Obese
• Overweight

Intervention

Drug:
• LY3502970
Administered orally.

Locations

Country	Name	City	State
United States	Labcorp Clinical Research LP	Dallas	Texas
United States	LabCorp CRU, Inc.	Daytona Beach	Florida
United States	LabCorp CRU, Inc.	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970	PK: AUC[0-24] of LY3502970	Predose up to 92 days postdose
Primary	PK: Maximum Observed Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose up to 92 days postdose
Primary	PK: Time to Maximum Observed Concentration (Tmax) of LY3502970	PK: Tmax of LY3502970	Predose up to 92 days postdose
Secondary	PK: AUC[0-24] of LY3502970 in fed state	PK: AUC[0-24] of LY3502970 in fed state	Predose up to 92 days postdose
Secondary	PK: Cmax of LY3502970 in fed state	PK: Cmax of LY3502970 in fed state	Predose up to 92 days postdose
Secondary	PK: Tmax of LY3502970 in fed state	PK: Tmax of LY3502970 in fed state	Predose up to 92 days postdose