A Study of LY3463251 in Healthy Participants
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ClinicalTrials.gov Identifier: NCT03764774 |
Recruitment Status :
Terminated
(Trial was terminated due to an insufficient benefit/tolerability ratio)
First Posted : December 5, 2018
Last Update Posted : December 21, 2020
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The purpose of this study is to evaluate the safety and tolerability (side effects) of single (Part A) and multiple (Part B) doses of the study drug when it is administered subcutaneously (under the skin) into the abdomen.
This is a two-part study. Participants will enroll in only one part. For each participant, Part A will last about 10 weeks and Part B will last about 23 weeks, including screening.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Healthy | Drug: LY3463251 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 118 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Basic Science |
Official Title: | A Randomized, Placebo-Controlled, Subject- and Investigator-Blind, Single and Multiple Dose, Safety, Tolerability, and Pharmacokinetics Study of LY3463251 in Healthy and Overweight Healthy Subjects |
Actual Study Start Date : | December 6, 2018 |
Actual Primary Completion Date : | December 7, 2020 |
Actual Study Completion Date : | December 7, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: LY3463251 Single dose
Single dose of LY3463251 administered subcutaneously (SC)
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Drug: LY3463251
Administered SC |
Placebo Comparator: Placebo Single dose
Single dose of placebo administered SC
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Drug: Placebo
Administered SC |
Experimental: LY3463251 Multiple Dose
Multiple doses of LY3463251 administered SC
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Drug: LY3463251
Administered SC |
Placebo Comparator: Placebo Multiple Dose
Multiple doses of placebo administered SC
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Drug: Placebo
Administered SC |
- Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through follow up in Part A (up to Day 42); Baseline through follow up in Part B (up to Day 123) ]A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3463251 [ Time Frame: Baseline to Day 29 (Part A); Baseline to Day 107 (Part B) ]PK: Cmax of LY3463251
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3463251 [ Time Frame: Baseline to Day 29 (Part A); Baseline to Day 107(Part B) ]PK: AUC of LY3463251
- Pharmacodynamics (PD): AUC of glucose [ Time Frame: Baseline to Day 85 (Part B) ]PD: AUC of glucose
- Change from Baseline in Body Weight [ Time Frame: Baseline, Day 85 (Part B) ]Change from Baseline in Body Weight
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Healthy males and females
Exclusion Criteria:
- Diagnosed with Type 1 or Type 2 diabetes
- Women who are of childbearing potential or who are breastfeeding
- Donated blood of more than 500 millilitres (mL) within the previous 3 months of study screening
- Have used any tobacco product within 3 months of Day -1, or are unwilling to refrain from the use of tobacco during the study
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03764774
United States, Florida | |
Covance Clinical Research Inc | |
Daytona Beach, Florida, United States, 32117 |
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 |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT03764774 |
Other Study ID Numbers: |
17110 J1D-MC-GZAA ( Other Identifier: Eli Lilly and Company ) |
First Posted: | December 5, 2018 Key Record Dates |
Last Update Posted: | December 21, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |