A Study of LY3502970 in Healthy Overweight and Obese Participants
A Multiple Dose Study in Healthy Overweight and Obese Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Florida
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Miami, Florida, United States, 33143
- Qps-Mra, Llc
-
-
Kansas
-
Lenexa, Kansas, United States, 66219
- ICON Early Phase Services Lenexa Center
-
-
Texas
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San Antonio, Texas, United States, 78209
- ICON Early Phase Services
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 %
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: LY3502970 Cohort 1
Participants received oral doses of 2 milligrams (mg) LY3502970 from days 1-14 and 3 mg LY3502970 from days 15-28 once daily (QD).
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Administered orally.
|
|
Experimental: LY3502970 Cohort 2
Participants received oral doses of 1 mg LY3502970 from days 1-7, 2 mg LY3502970 from days 8-21 and 3 mg LY3502970 from days 22-28 QD.
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Administered orally.
|
|
Experimental: LY3502970 Cohort 3
Participants received oral doses of 1 mg LY3502970 from days 1-14, 2 mg LY3502970 from days 15-21 and 3 mg LY3502970 from days 22-28 QD.
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Administered orally.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
Time Frame: Baseline up to Day 42
|
A TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment.
An SAE is any adverse event from this study that results in one of the following: Death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability/incapacity, congenital anomaly/birth defect, important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require intervention to prevent one of the other outcomes listed in the definition above.
An overall summary of SAEs and other non-serious adverse events, regardless of causality, will be reported in the Reported Adverse Events module.
|
Baseline up to Day 42
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3502970 on Day 1
Time Frame: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
PK: AUC[0-tlast] of LY3502970
|
Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
|
PK: Maximum Observed Concentration (Cmax) of LY3502970 on Day 1
Time Frame: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
PK: Cmax of LY3502970
|
Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
|
PK: Time to Maximum Observed Concentration (Tmax) of LY3502970 on Day 1
Time Frame: Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
PK: Tmax of LY3502970
|
Day 1 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
|
PK: AUC[0-tlast] of LY3502970 on Day 28
Time Frame: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
PK: AUC[0-tlast] of LY3502970
|
Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
|
PK: Cmax of LY3502970 on Day 28
Time Frame: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
PK: Cmax of LY3502970
|
Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
|
PK: Tmax of LY3502970 on Day 28
Time Frame: Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
PK: Tmax of LY3502970
|
Day 28 (Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16 and 24 hours post-dose)
|
|
Pharmacodynamics (PD): Change From Baseline in Body Weight
Time Frame: Baseline through Day 29
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PD: Change From Baseline in Body Weight
|
Baseline through Day 29
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Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Study Director: 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), Eli Lilly and Company
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 18453
- J2A-MC-GZGK (Other Identifier: Eli Lilly and Company)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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