Back to resultsA Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
Primary Purpose
Healthy, Obese
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3502970
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
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
Sites / Locations
- LabCorp CRU, Inc.
- Labcorp Clinical Research LP
- LabCorp CRU, Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
LY3502970 (Part A)
LY3502970 (Part B)
Arm Description
The multiple doses of LY3502970 administered orally either in tablet or capsule formulations.
The multiple doses of LY3502970 administered orally in tablet formulation.
Outcomes
Primary Outcome Measures
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
PK: Maximum Observed Concentration (Cmax) of LY3502970
PK: Cmax of LY3502970
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970
PK: Tmax of LY3502970
Secondary Outcome Measures
PK: AUC[0-24] of LY3502970 in fed state
PK: AUC[0-24] of LY3502970 in fed state
PK: Cmax of LY3502970 in fed state
PK: Cmax of LY3502970 in fed state
PK: Tmax of LY3502970 in fed state
PK: Tmax of LY3502970 in fed state
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05841238
Brief Title
A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
September 14, 2023 (Actual)
Study Completion Date
October 11, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Obese
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Part A open label. Part B double blinded.
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3502970 (Part A)
Arm Type
Experimental
Arm Description
The multiple doses of LY3502970 administered orally either in tablet or capsule formulations.
Arm Title
LY3502970 (Part B)
Arm Type
Experimental
Arm Description
The multiple doses of LY3502970 administered orally in tablet formulation.
Intervention Type
Drug
Intervention Name(s)
LY3502970
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the 24 Hour Time Point (AUC[0-24]) of LY3502970
Description
PK: AUC[0-24] of LY3502970
Time Frame
Predose up to 92 days postdose
Title
PK: Maximum Observed Concentration (Cmax) of LY3502970
Description
PK: Cmax of LY3502970
Time Frame
Predose up to 92 days postdose
Title
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970
Description
PK: Tmax of LY3502970
Time Frame
Predose up to 92 days postdose
Secondary Outcome Measure Information:
Title
PK: AUC[0-24] of LY3502970 in fed state
Description
PK: AUC[0-24] of LY3502970 in fed state
Time Frame
Predose up to 92 days postdose
Title
PK: Cmax of LY3502970 in fed state
Description
PK: Cmax of LY3502970 in fed state
Time Frame
Predose up to 92 days postdose
Title
PK: Tmax of LY3502970 in fed state
Description
PK: Tmax of LY3502970 in fed state
Time Frame
Predose up to 92 days postdose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
LabCorp CRU, Inc.
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Labcorp Clinical Research LP
City
Dallas
State/Province
Texas
ZIP/Postal Code
75247
Country
United States
Facility Name
LabCorp CRU, Inc.
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53704
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multiple Dose Study of LY3502970 in Healthy Overweight and Obese Participants
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