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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03115099
• Date of registration: 11/04/2017
• Prospective Registration: Yes
• Primary sponsor: Eli Lilly and Company
• Public title: A Study of LY3325656 in Healthy Participants and Participants With Type 2 Diabetes
• Scientific title: A Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of LY3325656 After Single Dose in Healthy Subjects and Patients With Type 2 Diabetes
• Date of first enrolment: May 31, 2017
• Target sample size: 80
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03115099
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Singapore

Contacts

• Name: 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)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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



Age minimum: 21 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Liraglutide

Drug: Sitagliptin

Drug: Placebo

Drug: LY3325656

Primary Outcome(s)

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]

Secondary Outcome(s)

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

Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3325656 [Time Frame: Baseline up to 72 hours after each dose of study drug]

Secondary ID(s)

16433

I8U-MC-DMBA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors