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A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT03115099
Recruitment Status : Completed
First Posted : April 14, 2017
Last Update Posted : August 23, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:

The aim of this trial is to evaluate the safety of single doses of a study drug known as LY3325656 that is given orally to healthy participants and participants with type 2 diabetes. Information about any side effects that may occur will be collected.

It 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.

The study consists of two parts. Part A will study healthy participants over approximately 12 weeks and Part B will study participants with type 2 diabetes over approximately 5 weeks, excluding screening. Screening is required within 28 days of the start of the study.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: LY3325656 Drug: Placebo Drug: Liraglutide Drug: Sitagliptin Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3325656 After Single Dose in Healthy Subjects and Patients With Type 2 Diabetes
Actual Study Start Date : May 31, 2017
Actual Primary Completion Date : April 5, 2018
Actual Study Completion Date : April 5, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo (Part A)
Single oral dose of placebo (sugar pill) administered to healthy participants in up to 1 study period in Part A
Drug: Placebo
Administered orally

Experimental: LY3325656 (Part A)
Single ascending dose of LY3325656 administered orally to healthy participants in up to 3 study periods in Part A
Drug: LY3325656
Administered orally

Placebo Comparator: Placebo (Part B)
Single oral dose of placebo (sugar pill) administered to participants with T2DM in 1 study period in Part B
Drug: Placebo
Administered orally

Experimental: LY3325656 (Part B)
Single oral dose of LY3325656 administered to participants with T2DM in 1 study period in Part B
Drug: LY3325656
Administered orally

Active Comparator: Liraglutide (Part B)
Single subcutaneous dose of liraglutide administered to participants with T2DM in 1 study period in Part B
Drug: Liraglutide
Administered subcutaneously

Experimental: LY3325656 + Sitagliptin (Part B)
Single oral dose of LY3325656 and sitagliptin administered to participants with T2DM in 1 study period in Part B
Drug: LY3325656
Administered orally

Drug: Sitagliptin
Administered orally




Primary Outcome Measures :
  1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through approximately 12 weeks and 5 weeks after first administration of study drug in Parts A and B, respectively ]
    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 :
  1. Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656 [ Time Frame: Baseline up to 72 hours after each dose of study drug ]
    Pharmacokinetics: Area Under the Concentration Curve of LY3325656 From Time Zero to 24 Hours [AUC(0-24)]

  2. Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656 [ Time Frame: Baseline up to 72 hours after each dose of study drug ]
    Pharmacokinetics: Maximum Concentration (Cmax) of LY3325656



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

For all participants:

  • Must be a male, or a female who cannot become pregnant, and who is either a healthy participant, or who has type 2 diabetes
  • Have a screening body mass index (BMI) of at least 18.5 kilograms per square meter (kg/m²)
  • Have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study

For participants with Type 2 Diabetes Mellitus:

  • Have diabetes controlled on diet and exercise with or without metformin for at least 30 days prior to screening, or on sulfonylureas with or without metformin
  • Have a glycated hemoglobin (HbA1c) value of greater than or equal to 7% and less than or equal to 11% at screening (exercise with or without metformin)
  • Have a HbA1c value of greater than or equal to 7% and less than or equal to 8.5% at screening (sulfonylureas with or without metformin)

Exclusion Criteria:

For all participants:

  • Are currently participating in another clinical study or completed one in the last 30 days
  • Are allergic to LY3325656 or other related drugs
  • Have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study
  • Have electrocardiogram (ECG) readings that are not suitable for the study
  • Are infected with hepatitis B
  • Are infected with human immunodeficiency virus (HIV)
  • Have donated more than 450 mL of blood in the last 3 months or if have donated any blood in the last month
  • Have a regular alcohol intake greater than 21 units/week (male), or 14 units/week (female), or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
  • Smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic

For participants with Type 2 Diabetes Mellitus:

  • Have had heart disease or stroke within 6 months before entering the study
  • Have health complications due to poorly controlled diabetes as shown by blood and urine laboratory test results or based on physical examination and medical assessment as determined by the study doctor
  • Have been hospitalized for poor control of diabetes (keto-acidotic episode) in the last 6 months
  • Have used insulin to control diabetes in the last 6 months
  • Show symptoms of high blood sugar e.g. frequent urination, always feeling thirsty, or unexpected weight loss

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03115099


Locations
Singapore
For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
Singapore, Singapore, 117597
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
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

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03115099     History of Changes
Other Study ID Numbers: 16433
I8U-MC-DMBA ( Other Identifier: Eli Lilly and Company )
First Posted: April 14, 2017    Key Record Dates
Last Update Posted: August 23, 2018
Last Verified: August 2018

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

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Liraglutide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action