Back to resultsA Study of LY3305677 in Participants With Obesity Or Overweight
Primary Purpose
Overweight, Obesity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
LY3305677
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Overweight
Eligibility Criteria
Inclusion Criteria: Participants who are overtly healthy as determined by medical evaluation Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²) Exclusion Criteria: Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma
Sites / Locations
- Anaheim Clinical Trials, LLC
- ICON Early Phase Services
- ICON Early Phase Services Lenexa Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY3305677
Placebo
Arm Description
LY3305677 administered subcutaneously (SC)
Placebo administered SC
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): Maximum Concentration (Cmax) of LY3305677
PK: Cmax of LY3305677
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677
PK: AUC of LY3305677
Pharmacodynamics (PD): Percentage change in Body Weight
PD: Percentage change in Body Weight
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05623839
Brief Title
A Study of LY3305677 in Participants With Obesity Or Overweight
Official Title
A Multiple Dose Titration Study in Participants With Obesity or Overweight to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
November 16, 2022 (Actual)
Primary Completion Date
June 27, 2023 (Actual)
Study Completion Date
June 27, 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 learn about the safety and tolerability of LY3305677 when given to participants with obesity or overweight. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3305677 or placebo given just under the skin. For each participant, the study will last about approximately 28 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obesity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3305677
Arm Type
Experimental
Arm Description
LY3305677 administered subcutaneously (SC)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
LY3305677
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
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
Baseline through Week 20
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3305677
Description
PK: Cmax of LY3305677
Time Frame
Predose up to 72 hours postdose
Title
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3305677
Description
PK: AUC of LY3305677
Time Frame
Predose up to 72 hours postdose
Title
Pharmacodynamics (PD): Percentage change in Body Weight
Description
PD: Percentage change in Body Weight
Time Frame
Baseline through Week 20
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 who are overtly healthy as determined by medical evaluation
Participants with stable weight for 3 months and body mass index of 27.0 and 50.0 kilograms per square meter (kg/m²)
Exclusion Criteria:
Have history of type 1 diabetes mellitus or type 2 diabetes mellitus, ketoacidosis, or hyperosmolar state or coma
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
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
ICON Early Phase Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
ICON Early Phase Services Lenexa Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3305677 in Participants With Obesity Or Overweight
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