A Study of LY3084077 in Healthy Participants
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT01846702
Collaborator
(none)
43
1
2
7
6.1
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
43 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Basic Science
Official Title:
A Single-Dose, Dose-Escalation Study to Determine the Safety, Tolerability, and Pharmacokinetics of LY3084077 in Healthy Subjects
Study Start Date
:
May 1, 2013
Actual Primary Completion Date
:
Dec 1, 2013
Actual Study Completion Date
:
Dec 1, 2013
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Single dose of placebo matching LY3084077 administered subcutaneously (SC). |
Drug: Placebo
Given as a SC injection.
|
| Experimental: LY3084077 Single escalating doses (1 mg up to 300 mg) of LY3084077 administered SC. |
Drug: LY3084077
Given as a SC injection.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Pre-dose, Up to Day 190]
An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.
Secondary Outcome Measures
- Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 [Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose]
- PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 [Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose]
- Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides [Baseline, Up to Day 15]
Percent change=(measure at time t-measure at baseline)/measure at baseline*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
- PD: Change From Baseline in Fasting Insulin [Baseline, Up to Day 15]
LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
- PD: Change From Baseline in Weight [Baseline, Up to Day 15]
- PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal [Baseline, Day 2]
LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
- PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal [Baseline, Day 2]
LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
- PD: Change From Baseline to Day 2 in Fasting Glucagon [Baseline, Up to Day 2]
LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction.
- Number of Participants Developing Anti-LY3084077 Antibodies [Pre-dose, Up to Day 190]
The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers.
Eligibility Criteria
Criteria
Ages Eligible for Study:
21 Years
to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Singapore | Singapore | 117597 |
Sponsors and Collaborators
- Eli Lilly and Company
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 Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01846702
Other Study ID Numbers:
- 14530
- I6P-MC-FMRA
First Posted:
May 3, 2013
Last Update Posted:
Jul 30, 2018
Last Verified:
Oct 1, 2017
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered subcutaneously (SC). | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC |
| Period Title: Overall Study | |||||||
| STARTED | 6 | 6 | 7 | 6 | 6 | 6 | 6 |
| Received at Least 1 Dose of Study Drug | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| COMPLETED | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| NOT COMPLETED | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
Baseline Characteristics
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 | Total |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered subcutaneously (SC). | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3074077 administered SC. | 30 mg single dose of LY3074077 administered SC. | 100 mg single dose of LY3074077 administered SC. | 150 mg single dose of LY3074077 administered SC. | Total of all reporting groups |
| Overall Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 | 42 |
| Age (years) [Mean (Standard Deviation) ] | ||||||||
| Mean (Standard Deviation) [years] |
35.7
(14)
|
30.7
(13.2)
|
34.5
(11.2)
|
32.7
(7.4)
|
40.7
(12.6)
|
30.5
(5.0)
|
36.3
(4.8)
|
34.4
(10.2)
|
| Sex: Female, Male (Count of Participants) | ||||||||
| Female |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
2
4.8%
|
| Male |
6
100%
|
5
83.3%
|
6
100%
|
6
100%
|
5
83.3%
|
6
100%
|
6
100%
|
40
95.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
42
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | ||||||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
6
100%
|
6
100%
|
6
100%
|
4
66.7%
|
6
100%
|
6
100%
|
6
100%
|
40
95.2%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
0
0%
|
0
0%
|
0
0%
|
2
33.3%
|
0
0%
|
0
0%
|
0
0%
|
2
4.8%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | ||||||||
| Singapore |
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
6
100%
|
42
100%
|
Outcome Measures
| Title | Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration |
|---|---|
| Description | An SAE is an adverse event that results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. |
| Time Frame | Pre-dose, Up to Day 190 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC | 10 mg single dose of LY3084077 administered SC | 30 mg single dose of LY3084077 administered SC | 100 mg single dose of LY3084077 administered SC | 150 mg single dose of LY3084077 administered SC |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Number [participants] |
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Title | Pharmacokinetics (PK): Area Under the Concentration Curve Zero to Infinity (AUC[0-∞]) GLP1-Fc Domain of LY3084077 |
|---|---|
| Description | |
| Time Frame | Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable PK data. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC. |
| Measure Participants | 6 | 6 | 2 | 5 | 4 | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [microgram*hour/milliliter (μg•hr/mL)] |
NA
(NA)
|
NA
(NA)
|
8.74
(13)
|
17.9
(42)
|
61.8
(34)
|
248
(221)
|
249
(20)
|
| Title | PK: Maximum Concentration (Cmax) GLP1-Fc Domain of LY3084077 |
|---|---|
| Description | |
| Time Frame | Day 1 and Day 29: Predose, 2,4,8,12,24,36,48,72,96,120,168,336 hours post dose |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable PK data. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC | 1 mg single dose of LY3084077 administered SC | 3 mg single dose of LY3084077 administered SC | 10 mg single dose of LY3084077 administered SC | 30 mg single dose of LY3084077 administered SC | 100 mg single dose of LY3084077 administered SC | 150 mg single dose of LY3084077 administered SC |
| Measure Participants | 6 | 6 | 4 | 6 | 6 | 6 | 6 |
| Geometric Mean (Geometric Coefficient of Variation) [microgram/milliliter (μg/mL)] |
NA
(NA)
|
NA
(NA)
|
0.0428
(53)
|
0.0745
(24)
|
0.188
(78)
|
1.14
(79)
|
1.23
(48)
|
| Title | Pharmacodynamics (PD): Percent Change From Baseline in Fasting Triglycerides |
|---|---|
| Description | Percent change=(measure at time t-measure at baseline)/measure at baseline*100%). Least Square Means (LS means) were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| Time Frame | Baseline, Up to Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable fasting triglycerides data. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Least Squares Mean (Standard Deviation) [percent] |
-23.7
(12.8)
|
-13.7
(12.8)
|
-35.3
(12.6)
|
-30.4
(12.6)
|
-23.8
(13.6)
|
-2.50
(14.2)
|
-43.7
(13.0)
|
| Title | PD: Change From Baseline in Fasting Insulin |
|---|---|
| Description | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| Time Frame | Baseline, Up to Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable fasting insulin data. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Least Squares Mean (Standard Error) [picomole/Liter (pmol/L)] |
-24.0
(8.23)
|
-24.6
(8.55)
|
-21.4
(8.41)
|
4.90
(8.26)
|
-28.4
(9.19)
|
-11.9
(8.29)
|
-26.6
(8.44)
|
| Title | PD: Change From Baseline in Weight |
|---|---|
| Description | |
| Time Frame | Baseline, Up to Day 15 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Zero participants had weight measured and therefore change from baseline in weight was not calculable across all arms. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC. |
| Measure Participants | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Title | PD: Change From Baseline Up to Day 2 in Level of C-peptide AUC (Predose to 4 Hours) After a Standard Meal |
|---|---|
| Description | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| Time Frame | Baseline, Day 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable C-peptide AUC before and after a standard meal data. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Least Squares Mean (Standard Error) [picomole*hour/Liter (pmol*h/L)] |
-292
(579)
|
310
(559)
|
-157
(579)
|
1313
(564)
|
372
(592)
|
-192
(564)
|
973
(568)
|
| Title | PD: Change From Baseline to Day 2 Incremental AUC Level of Blood Glucose (Predose to 6 Hours) After a Standard Meal |
|---|---|
| Description | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| Time Frame | Baseline, Day 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable incremental glucose AUC before and after a standard meal data. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Least Squares Mean (Standard Error) [millomole*hour/Liter (mmol*h/L)] |
-1.76
(1.16)
|
0.758
(1.18)
|
-0.202
(1.14)
|
-0.350
(1.15)
|
-2.14
(1.13)
|
-1.79
(1.13)
|
-1.82
(1.15)
|
| Title | PD: Change From Baseline to Day 2 in Fasting Glucagon |
|---|---|
| Description | LS means were calculated using MMRM analysis adjusting for the random effect of participant, effect of baseline, and fixed categorical effects of treatment, visit, and treatment-by-visit interaction. |
| Time Frame | Baseline, Up to Day 2 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and have evaluable fasting glucagon data. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Least Squares Mean (Standard Error) [pmol/L] |
3.17
(1.98)
|
0.940
(1.96)
|
2.38
(1.98)
|
-0.514
(1.95)
|
4.15
(1.96)
|
1.01
(1.99)
|
1.52
(1.96)
|
| Title | Number of Participants Developing Anti-LY3084077 Antibodies |
|---|---|
| Description | The number of participants with 1:4 baseline and postbaseline positive anti-LY3084077 antibody titers. |
| Time Frame | Pre-dose, Up to Day 190 |
Outcome Measure Data
| Analysis Population Description |
|---|
| All randomized participants who received at least one dose of study drug and had evaluable baseline and postbaseline antibody titers. |
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 |
|---|---|---|---|---|---|---|---|
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC. | 10 mg single dose of LY3084077 administered SC. | 30 mg single dose of LY3084077 administered SC. | 100 mg single dose of LY3084077 administered SC. | 150 mg single dose of LY3084077 administered SC. |
| Measure Participants | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
| Number [participants] |
0
0%
|
1
16.7%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Adverse Events
| Time Frame | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | All randomized participants who received at least one dose of study drug. | |||||||||||||
| Arm/Group Title | Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 | |||||||
| Arm/Group Description | Single dose of placebo matching LY3084077 administered SC. | 1 mg single dose of LY3084077 administered SC. | 3 mg single dose of LY3084077 administered SC | 10 mg single dose of LY3084077 administered SC | 30 mg single dose of LY3084077 administered SC | 100 mg single dose of LY3084077 administered SC | 150 mg single dose of LY3084077 administered SC | |||||||
All Cause Mortality |
||||||||||||||
| Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||||
Serious Adverse Events |
||||||||||||||
| Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | |||||||
| Gastrointestinal disorders | ||||||||||||||
| Gastritis | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||||||||||||
| Placebo Cohort 1 | LY3084077 Cohort 2 | LY3084077 Cohort 3 | LY3084077 Cohort 4 | LY3084077 Cohort 5 | LY3084077 Cohort 6 | LY3084077 Cohort 7 | ||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 6/6 (100%) | 6/6 (100%) | 3/6 (50%) | 3/6 (50%) | 5/6 (83.3%) | 6/6 (100%) | 6/6 (100%) | |||||||
| Ear and labyrinth disorders | ||||||||||||||
| Hypoacusis | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Eye disorders | ||||||||||||||
| Eyelid pain | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Lacrimation increased | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Gastrointestinal disorders | ||||||||||||||
| Abdominal distension | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 3/6 (50%) | 3 | 3/6 (50%) | 3 |
| Colitis | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Diarrhoea | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| Nausea | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 3/6 (50%) | 4 |
| Vomiting | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 1/6 (16.7%) | 1 |
| General disorders | ||||||||||||||
| Catheter site erythema | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Catheter site haematoma | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 |
| Catheter site pain | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Early satiety | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Fatigue | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Feeling hot | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 3 |
| Injection site haematoma | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Injection site pain | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Pain | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Pyrexia | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
| Thirst | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Infections and infestations | ||||||||||||||
| Dengue fever | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Influenza | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Upper respiratory tract infection | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Injury, poisoning and procedural complications | ||||||||||||||
| Procedural site reaction | 3/6 (50%) | 3 | 4/6 (66.7%) | 6 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 2 |
| Thermal burn | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||||||||||
| Decreased appetite | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 4/6 (66.7%) | 4 | 0/6 (0%) | 0 |
| Hypoglycaemia | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 2/6 (33.3%) | 4 |
| Musculoskeletal and connective tissue disorders | ||||||||||||||
| Musculoskeletal discomfort | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Musculoskeletal stiffness | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Nervous system disorders | ||||||||||||||
| Dizziness | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Headache | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 3 |
| Lethargy | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Presyncope | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Psychiatric disorders | ||||||||||||||
| Anxiety | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||
| Cough | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
| Increased upper airway secretion | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Oropharyngeal pain | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 3/6 (50%) | 3 | 1/6 (16.7%) | 1 |
| Rhinorrhoea | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||||||||||
| Acne | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
| Dry skin | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 |
| Pruritus | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 | 0/6 (0%) | 0 |
| Rash | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Chief Medical Officer |
|---|---|
| Organization | Eli Lilly and Company |
| Phone | 800-545-5979 |
Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01846702
Other Study ID Numbers:
- 14530
- I6P-MC-FMRA
First Posted:
May 3, 2013
Last Update Posted:
Jul 30, 2018
Last Verified:
Oct 1, 2017