A First-in-Human Study of LY3009385 in Healthy Participants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01477567
First received: November 18, 2011
Last updated: October 2, 2014
Last verified: October 2014
Results First Received: June 13, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Basic Science
Condition: Diabetes Mellitus, Type 2
Interventions: Drug: LY3009385
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
0.3 mg LY3009385 LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
1 mg LY3009385 LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
3 mg LY3009385 LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
9 mg LY3009385 LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
22 mg LY3009385 LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
54 mg LY3009385 LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Placebo Placebo: saline, subcutaneous (SC) injection, single dose on Day 1

Participant Flow:   Overall Study
    0.3 mg LY3009385     1 mg LY3009385     3 mg LY3009385     9 mg LY3009385     22 mg LY3009385     54 mg LY3009385     Placebo  
STARTED     5     6     6     6     6     5     6  
Received at Least 1 Dose of Study Drug     5     6     6     6     6     5     6  
COMPLETED     5     6     6     6     6     5     6  
NOT COMPLETED     0     0     0     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All enrolled participants.

Reporting Groups
  Description
0.3 mg LY3009385 LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
1 mg LY3009385 LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
3 mg LY3009385 LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
9 mg LY3009385 LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
22 mg LY3009385 LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
54 mg LY3009385 LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
Placebo Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
Total Total of all reporting groups

Baseline Measures
    0.3 mg LY3009385     1 mg LY3009385     3 mg LY3009385     9 mg LY3009385     22 mg LY3009385     54 mg LY3009385     Placebo     Total  
Number of Participants  
[units: participants]
  5     6     6     6     6     5     6     40  
Age  
[units: years]
Mean ± Standard Deviation
  39.2  ± 13.5     36.7  ± 12.5     33.3  ± 14.0     31.7  ± 8.4     34.7  ± 10.4     34.6  ± 9.9     27.5  ± 4.3     33.8  ± 10.6  
Gender  
[units: participants]
               
Female     0     0     0     1     1     0     0     2  
Male     5     6     6     5     5     5     6     38  
Ethnicity (NIH/OMB)  
[units: participants]
               
Hispanic or Latino     0     0     0     0     0     0     0     0  
Not Hispanic or Latino     5     6     6     6     6     5     6     40  
Unknown or Not Reported     0     0     0     0     0     0     0     0  
Race (NIH/OMB)  
[units: participants]
               
American Indian or Alaska Native     0     0     0     0     0     0     0     0  
Asian     5     6     6     6     6     5     6     40  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0     0     0     0  
Black or African American     0     0     0     0     0     0     0     0  
White     0     0     0     0     0     0     0     0  
More than one race     0     0     0     0     0     0     0     0  
Unknown or Not Reported     0     0     0     0     0     0     0     0  
Region of Enrollment  
[units: participants]
               
Singapore     5     6     6     6     6     5     6     40  
Study-Specific Measure  
[units: milligramsĀ perĀ deciliterĀ (mg/dL)]
Mean ± Standard Deviation
  82.84  ± 4.99     92.40  ± 4.86     84.45  ± 10.60     96.02  ± 8.35     89.40  ± 6.29     92.46  ± 11.12     89.08  ± 5.17     89.62  ± 8.29  



  Outcome Measures
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1.  Primary:   Number of Participants With One or More Drug-related Adverse Events (AEs) or Any Serious AEs   [ Time Frame: Baseline through Day 28 ]

2.  Secondary:   Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3009385   [ Time Frame: Predose through Day 28 ]

3.  Secondary:   Pharmacokinetics: Maximum Concentration (Cmax)   [ Time Frame: Predose through Day 28 ]

4.  Secondary:   Change in Level of Blood Glucose Before and After a Standard Meal   [ Time Frame: Baseline, Day 5, and Day 14 ]

5.  Secondary:   Change in Level of C-peptide Before and After a Standard Meal   [ Time Frame: Baseline, Day 5, and Day 14 ]

6.  Secondary:   Change in Level of Glucagon Before and After a Standard Meal   [ Time Frame: Baseline, Day 14 ]

7.  Secondary:   Number of Participants Forming Antibody to LY3009385   [ Time Frame: Baseline through Day 28 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01477567     History of Changes
Other Study ID Numbers: 14195, I5O-FW-GTCA
Study First Received: November 18, 2011
Results First Received: June 13, 2014
Last Updated: October 2, 2014
Health Authority: Singapore: Health Sciences Authority