Back to resultsA Study of LY3298176 in Healthy Participants and Participants With Type 2 Diabetes (T2DM)
Primary Purpose
Healthy, Type 2 Diabetes Mellitus (T2DM)
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3298176
Placebo
Dulaglutide
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
Inclusion Criteria:
- Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1 year before enrollment (Part C)
- Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to 40.0 kilograms per meter squared (kg/m²), inclusive
- Participants with T2DM (Part C only): have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin for at least 30 days or sulfonylureas). Participants receiving sulfonylureas may participate only if this treatment is stopped for at least 6 weeks before dosing with study drug
Exclusion Criteria:
- Have known allergies to LY3298176, glucagon-like peptide (GLP)-1 analogs, or related compounds
- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than 2-fold the upper limit of normal [ULN]) or gastrointestinal (GI) disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase (DPP)-IV inhibitors
Participants with T2DM (Part C only)
- Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
All Study Participants (Parts B and C only)
- have known allergies to LY3298176, GLP-1 analogs, or related compounds, or acetaminophen
Sites / Locations
- Miami Research Associates
- For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Active Comparator
Experimental
Placebo Comparator
Arm Label
LY3298176 (Part A)
Placebo (Part A)
LY3298176 (Part B)
Placebo (Part B)
Dulaglutide (Part B)
LY3298176 (Part C)
Placebo (Part C)
Arm Description
Escalating doses of LY3298176 administered subcutaneously (SC) once in healthy participants.
Placebo administered SC once in healthy participants.
Escalating doses of LY3298176 administered SC once weekly for four weeks in healthy participants.
Placebo administered SC once weekly for four weeks in healthy participants.
Dulaglutide administered SC once weekly for four weeks in healthy participants
Two dose levels of LY3298176 administered SC once weekly for four weeks in participants with T2DM.
Placebo administered SC once weekly for four weeks in participants with T2DM.
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 Administration
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): Area Under the Concentration Versus Time Curve (AUC) of LY3298176
PK: AUC of LY3298176
Pharmacodynamics (PD): AUC of Glucose
PD: AUC of Glucose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02759107
Brief Title
A Study of LY3298176 in Healthy Participants and Participants With Type 2 Diabetes (T2DM)
Official Title
A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176 and Multiple Doses in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 11, 2016 (Actual)
Primary Completion Date
June 26, 2017 (Actual)
Study Completion Date
June 26, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purposes of this study are to determine:
The safety of LY3298176 and any side effects that might be associated with it.
How much LY3298176 gets into the bloodstream and how long it takes the body to get rid of it.
How LY3298176 affects the levels of blood sugar.
This study includes 3 parts (A, B and C). Part A involves a single dose of LY3298176 taken as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in duration, including screening. Parts B and C involve 4 doses of LY3298176 taken once weekly (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in duration, including screening. Each participant will enroll in only one part.
This study is for research purposes only, and is not intended to treat any medical condition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Type 2 Diabetes Mellitus (T2DM)
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
198 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LY3298176 (Part A)
Arm Type
Experimental
Arm Description
Escalating doses of LY3298176 administered subcutaneously (SC) once in healthy participants.
Arm Title
Placebo (Part A)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC once in healthy participants.
Arm Title
LY3298176 (Part B)
Arm Type
Experimental
Arm Description
Escalating doses of LY3298176 administered SC once weekly for four weeks in healthy participants.
Arm Title
Placebo (Part B)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC once weekly for four weeks in healthy participants.
Arm Title
Dulaglutide (Part B)
Arm Type
Active Comparator
Arm Description
Dulaglutide administered SC once weekly for four weeks in healthy participants
Arm Title
LY3298176 (Part C)
Arm Type
Experimental
Arm Description
Two dose levels of LY3298176 administered SC once weekly for four weeks in participants with T2DM.
Arm Title
Placebo (Part C)
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC once weekly for four weeks in participants with T2DM.
Intervention Type
Drug
Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
Trulicity®
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 Administration
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 Day 43 (Part A) or Day 57 (Part B and C)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3298176
Description
PK: AUC of LY3298176
Time Frame
Baseline through Day 43 (Part A) or Day 57 (Part B and C)
Title
Pharmacodynamics (PD): AUC of Glucose
Description
PD: AUC of Glucose
Time Frame
Baseline, Day 2 and Day 22 (Part B and C)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1 year before enrollment (Part C)
Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to 40.0 kilograms per meter squared (kg/m²), inclusive
Participants with T2DM (Part C only): have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin for at least 30 days or sulfonylureas). Participants receiving sulfonylureas may participate only if this treatment is stopped for at least 6 weeks before dosing with study drug
Exclusion Criteria:
Have known allergies to LY3298176, glucagon-like peptide (GLP)-1 analogs, or related compounds
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than 2-fold the upper limit of normal [ULN]) or gastrointestinal (GI) disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase (DPP)-IV inhibitors
Participants with T2DM (Part C only)
Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
All Study Participants (Parts B and C only)
have known allergies to LY3298176, GLP-1 analogs, or related compounds, or acetaminophen
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
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Singapore
ZIP/Postal Code
117597
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
30473097
Citation
Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3.
Results Reference
derived
Links:
URL
https://www.lillytrialguide.com/en-US/studies/type-2-diabetes/GPGA#?postal=
Description
Click here for more information about this study:A Study of LY3298176 in Participants With Type 2 Diabetes (T2DM)
Learn more about this trial
A Study of LY3298176 in Healthy Participants and Participants With Type 2 Diabetes (T2DM)
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