Phase 1
Completed N=24
A Study of LY3143753 and LY3185643 in Healthy Participants
Healthy
Source: ClinicalTrials.gov NCT02342314 ↗
Enrolled (actual)
24
Serious AEs
4.4%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration — 0; 0; 0; 0 Participants
Summary
The study involves a single dose of LY3143753 or LY3185643, given as an injection into the abdomen. The study will evaluate the effects of the LY3143753 or LY3185643 on your body. The study is approximately 12 weeks for each participant, not including screening. Screening is required within 28 days prior to the start of the study. This study involves Part A (LY3143753) and Part B (LY3185643). Participants may only enroll in one part and at one dose level.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
0; 0; 0; 0; 1; 1 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Drug Concentration (Cmax) of Part A |
0.726; 1.05; 2.95; 5.73; 11.4 | — |
| SECONDARY PK: Cmax of Part B |
0.126; 0.367; 1.19; 0.951; 2.34; 4.25 | — |
| SECONDARY PK: Area Under the Concentration Curve From Zero to Infinity (AUC[0-∞]) of Part A |
1.44; 1.57; 5.76; 12.6; 22.6 | — |
| SECONDARY PK: AUC(0-∞) of Part B |
NA; 0.564; 2.61; 1.34; 3.73; 8.87 | — |
| SECONDARY PK: Time to Maximum Drug Concentration (Tmax) of Part A |
0.67; 0.83; 0.67; 1.04; 1.25 | — |
| SECONDARY PK: Tmax of Part B |
0.83; 0.67; 0.83; 0.67; 0.50; 1.25 | — |
| SECONDARY Pharmacodynamic (PD): Absolute Maximum Blood Glucose of Part A |
101; 168; 197; 179; 188; 177 | — |
| SECONDARY PD Absolute Maximum Blood Glucose of Part B |
95.1; 103; 98.1; 128; 117; 167 | — |
| SECONDARY PD: Maximum Glucose Increase (Gmax) of Part A |
4.14; 66.1; 103; 84.9; 91.5; 79.8 | — |
| SECONDARY PD: Gmax of Part B |
4.69; 7.2; 5.04; 28.1; 21.8; 76.1 | — |
| SECONDARY PD: Time to Maximum Blood Glucose (Gtmax) of Part A |
0.96; 1.00; 1.00; 0.67; 0.79; 0.58 | — |
| SECONDARY PD: Gtmax of Part B |
0.5; 0.5; 0.67; 1.0; 0.67; 0.75 | — |
| SECONDARY QT Interval as Corrected by the Fridericia Method (QTcF) Change From Baseline of Part A |
0.6; NA; 0.2; NA; 6.1; 6.1 | — |
| SECONDARY QTcF Change From Baseline of Part B |
-1.4; -2.9; -10.2; -5.9; -4.1; 0.5 | — |
Eligibility Criteria
Inclusion Criteria
- Overtly healthy males or females
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures
Exclusion Criteria
- Are investigator site personnel directly affiliated with this study and their immediate families
- Are currently enrolled in a clinical trial involving an investigational product (IP) or off-label use of a drug or device
- Have participated, within the last 3 months, in a clinical trial
- Have known or ongoing psychiatric disorders
- Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies
- Show evidence of hepatitis C and/or positive hepatitis C antibody
- Show evidence of hepatitis B and/or positive hepatitis B surface antigen
- History of/current phaeochromocytoma
- History of/current insulinoma
Data sourced from ClinicalTrials.gov (NCT02342314). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.