Back to resultsA Study of LY3305677 in Participants With Type 2 Diabetes
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
LY3305677
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Diabetes Mellitus, Type 2
Eligibility Criteria
Inclusion Criteria:
- Have Type II diabetes
- Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive
- Have a body weight of <150 kilograms (kg)
- Have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, CK values within the normal range at screening and Day -2.
Exclusion Criteria:
- Have Type 1 diabetes or latent autoimmune diabetes in adults
- Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening
- Have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Visit 1
- Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
- Have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening
- Have an estimated glomerular filtration rate <45 milliliters per minute per 1.73 meters squared of body surface area (mL/min/1.73 m²)
Sites / Locations
- Profil Institut für Stoffwechselforschung
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
LY3305677
Placebo
Arm Description
LY3305677 administered SC
Placebo administered SC
Outcomes
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
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677
PK: Cmax of LY3305677
PK: Area Under the Concentration-Time Curve (AUC) of LY3305677
PK: AUC of LY3305677
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in Fasting Plasma Glucose
PD: Change from Baseline in Fasting Plasma Insulin
PD: Change from Baseline in Fasting Plasma Insulin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03928379
Brief Title
A Study of LY3305677 in Participants With Type 2 Diabetes
Official Title
A Multiple-Ascending Dose Study in Patients With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3305677
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
October 27, 2019 (Actual)
Primary Completion Date
July 8, 2021 (Actual)
Study Completion Date
July 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this study is to learn more about the safety and side effects of LY3305677 when it is given as an injection just under the skin to participants with type 2 diabetes. The study will last about 20 weeks for each participant, not including screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3305677
Arm Type
Experimental
Arm Description
LY3305677 administered SC
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC
Intervention Type
Drug
Intervention Name(s)
LY3305677
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through 24 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of LY3305677
Description
PK: Cmax of LY3305677
Time Frame
Baseline through 48 hours postdose
Title
PK: Area Under the Concentration-Time Curve (AUC) of LY3305677
Description
PK: AUC of LY3305677
Time Frame
Baseline through 48 hours postdose
Title
Pharmacodynamics (PD): Change from Baseline in Fasting Plasma Glucose
Description
PD: Change from Baseline in Fasting Plasma Glucose
Time Frame
Baseline, through Week 16
Title
PD: Change from Baseline in Fasting Plasma Insulin
Description
PD: Change from Baseline in Fasting Plasma Insulin
Time Frame
Baseline, through Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have Type II diabetes
Body mass index (BMI) of 25-40 kilograms per square meter (kg/m²), inclusive
Have a body weight of <150 kilograms (kg)
Have clinical lab test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator; however, should have serum magnesium and potassium levels, along with lactate dehydrogenase, CK values within the normal range at screening and Day -2.
Exclusion Criteria:
Have Type 1 diabetes or latent autoimmune diabetes in adults
Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization for 6 months prior to screening
Have had an episode of severe hypoglycemia, defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery, within 6 months prior to Visit 1
Have an abnormal 12-lead electrocardiogram (ECG) at screening and/or Day -2 that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
Have poorly controlled hypertension at screening; or a change in antihypertensive medication within 30 days of screening
Have an estimated glomerular filtration rate <45 milliliters per minute per 1.73 meters squared of body surface area (mL/min/1.73 m²)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Profil Institut für Stoffwechselforschung
City
Neuss
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
41460
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of LY3305677 in Participants With Type 2 Diabetes
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