Phase 1
Completed N=43
A Study of LY3084077 in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT01846702 ↗
Enrolled (actual)
43
Serious AEs
2.4%
Results posted
Jul 2018
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 — 1; 0; 0; 0 participants
Summary
The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3084077 in healthy participants. The study will also investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected. The study is expected to last approximately 8 weeks for each participant.
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 |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 |
NA; NA; 8.74; 17.9; 61.8; 248 | — |
| SECONDARY PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 |
NA; NA; 0.0428; 0.0745; 0.188; 1.14 | — |
| SECONDARY Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides |
-23.7; -13.7; -35.3; -30.4; -23.8; -2.50 | — |
| SECONDARY PD: Change From Baseline in Fasting Insulin |
-24.0; -24.6; -21.4; 4.90; -28.4; -11.9 | — |
| SECONDARY PD: Change From Baseline in Weight |
— | — |
| SECONDARY PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal |
-292; 310; -157; 1313; 372; -192 | — |
| SECONDARY PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal |
-1.76; 0.758; -0.202; -0.350; -2.14; -1.79 | — |
| SECONDARY PD: Change From Baseline to Day 2 in Fasting Glucagon |
3.17; 0.940; 2.38; -0.514; 4.15; 1.01 | — |
| SECONDARY Number of Participants Developing Anti-LY3084077 Antibodies |
0; 1; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Have normal blood pressure
- Must be a healthy male or female who cannot become pregnant
- Have a body mass index (BMI) of 18.5 to 40.0 kg/m^2, inclusive, at screening
Exclusion Criteria
- Have known allergies to fibroblast growth factor-21 (FGF21) analogues, glucagon-like peptide-1 (GLP1), GLP1-analogues or other related compounds
- Have previous exposure to FGF21 analogues or GLP1 analogues
- Have received live vaccine(s) within 1 month of screening, or intend to during the study
- Have previously completed or withdrawn from this study
- Have or used to have health problems or laboratory test results or electrocardiogram (ECG) readings that in the opinion of the doctor, could make it unsafe to participate, or interfere with understanding the results of the study
- Have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- Have problems with the immune system, due to a disease or treatment
- Have a personal or family history of medullary thyroid carcinoma (MTC) or have multiple endocrine neoplasia syndrome type 2
- Have a history of pancreatitis
Data sourced from ClinicalTrials.gov (NCT01846702). 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.