A Study of LY3298176 in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

Sponsor

Eli Lilly and Company (Industry)

Overall Status

Completed

CT.gov ID

NCT02759107

Collaborator

(none)

198

Enrollment

Locations

Arms

13.5

Actual Duration (Months)

Patients Per Site

7.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Type 2 Diabetes Mellitus (T2DM)	Drug: LY3298176 Drug: Placebo Drug: Dulaglutide	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

198 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

May 11, 2016

Actual Primary Completion Date :

Jun 26, 2017

Actual Study Completion Date :

Jun 26, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3298176 (Part A) Escalating doses of LY3298176 administered subcutaneously (SC) once in healthy participants.	Drug: LY3298176 Administered SC
Placebo Comparator: Placebo (Part A) Placebo administered SC once in healthy participants.	Drug: Placebo Administered SC
Experimental: LY3298176 (Part B) Escalating doses of LY3298176 administered SC once weekly for four weeks in healthy participants.	Drug: LY3298176 Administered SC
Placebo Comparator: Placebo (Part B) Placebo administered SC once weekly for four weeks in healthy participants.	Drug: Placebo Administered SC
Active Comparator: Dulaglutide (Part B) Dulaglutide administered SC once weekly for four weeks in healthy participants	Drug: Dulaglutide Administered SC Other Names: Trulicity®
Experimental: LY3298176 (Part C) Two dose levels of LY3298176 administered SC once weekly for four weeks in participants with T2DM.	Drug: LY3298176 Administered SC
Placebo Comparator: Placebo (Part C) Placebo administered SC once weekly for four weeks in participants with T2DM.	Drug: Placebo Administered SC

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 [Baseline through Day 43 (Part A) or Day 57 (Part B and C)]
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 [Baseline through Day 43 (Part A) or Day 57 (Part B and C)]
PK: AUC of LY3298176
Pharmacodynamics (PD): AUC of Glucose [Baseline, Day 2 and Day 22 (Part B and C)]
PD: AUC of Glucose

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami Research Associates	South Miami	Florida	United States	33143
2	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.	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