Back to resultsA 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 focused on measuring Pharmacokinetics, Safety and Tolerability, LY3502970
Eligibility Criteria
Inclusion Criteria:
- Participants with stable body weight for at least one month prior to randomization.
- Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²)
- Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
Exclusion Criteria:
- Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs
- Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders
- Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %
Sites / Locations
- Qps-Mra, Llc
- ICON Early Phase Services Lenexa Center
- ICON Early Phase Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
LY3502970 (Dose Level 1)
LY3502970 (Dose Level 2)
LY3502970 (Dose Level 3)
Arm Description
LY3502970 administered orally.
LY3502970 administered orally.
LY3502970 administered orally.
Outcomes
Primary Outcome Measures
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
PK: AUC 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
Pharmacodynamics (PD): Change From Baseline in Body Weight
PD: Change From Baseline in Body Weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05313802
Brief Title
A Study of LY3502970 in Healthy Overweight and Obese Participants
Official Title
A Multiple Dose Study in Healthy Overweight and Obese Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
Study Type
Interventional
2. Study Status
Record Verification Date
October 1, 2022
Overall Recruitment Status
Completed
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
September 9, 2022 (Actual)
Study Completion Date
September 9, 2022 (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 the safety and tolerability of LY3502970 in healthy overweight and obese participants. The blood tests will be conducted to measure how much LY3502970 is in the bloodstream and how the body handles and eliminates LY3502970 in these participants. The study will last up to 42 days excluding the screening period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Obese
Keywords
Pharmacokinetics, Safety and Tolerability, LY3502970
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3502970 (Dose Level 1)
Arm Type
Experimental
Arm Description
LY3502970 administered orally.
Arm Title
LY3502970 (Dose Level 2)
Arm Type
Experimental
Arm Description
LY3502970 administered orally.
Arm Title
LY3502970 (Dose Level 3)
Arm Type
Experimental
Arm Description
LY3502970 administered orally.
Intervention Type
Drug
Intervention Name(s)
LY3502970
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Description
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Predose up to 42 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3502970
Description
PK: AUC of LY3502970
Time Frame
Predose up to 29 days postdose
Title
PK: Maximum Observed Concentration (Cmax) of LY3502970
Description
PK: Cmax of LY3502970
Time Frame
Predose up to 29 days postdose
Title
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970
Description
PK: Tmax of LY3502970
Time Frame
Predose up to 29 days postdose
Title
Pharmacodynamics (PD): Change From Baseline in Body Weight
Description
PD: Change From Baseline in Body Weight
Time Frame
Predose through Day 28
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:
Participants with stable body weight for at least one month prior to randomization.
Participants with body mass index (BMI) of greater than or equal to (≥) 27.0 kilograms per meter squared (kg/m²)
Male participants who agree to use highly effective/effective methods of contraception and female participants not of childbearing potential
Exclusion Criteria:
Have known allergies to LY3502970 or other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs
Significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological or neurological disorders
Have any type of diabetes with hemoglobin A1c (HbA1c) ≥6.5 %
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
Qps-Mra, Llc
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
ICON Early Phase Services Lenexa Center
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66219
Country
United States
Facility Name
ICON Early Phase Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3502970 in Healthy Overweight and Obese Participants
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