A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants

OPKO Health

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: LY2944876

Study type: Interventional

Funder types: Industry

Identifiers

NCT02188303

I7I-EW-XNAB (Other Identifier)

15247

Details and patient eligibility

About

LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of the study will assess the safety and tolerability of single doses of LY2944876 in Japanese participants. Participation is expected to last up to about 7 weeks, not including screening.

Part B of the study will investigate the safety and tolerability of multiple doses of LY2944876 in non Japanese participants. Participation is expected to last up to about 8 weeks, not including screening.

All doses will be administered as injections into the fatty layer just beneath the skin.

Screening is required within 28 days prior to the start of the study. All participants will attend a post study safety assessment approximately 6 weeks after their final dose.

Enrollment: 48 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy males or female participants
• Are first generation Japanese participants (Part A) or non-Japanese participants (Part B)
• Have a body mass index (BMI) of 18.5 to 30 kilogram per meter square (kg/m^2), inclusive, for Part A and a BMI of 25 to 40 kg/m^2, inclusive, for Part B at screening
• Have normal blood pressure and heart rate (after approximately 5 minutes supine and approximately 2 minutes standing) as determined by the investigator at screening

Exclusion criteria

• Have known allergies to LY2944876, related compounds or any components of the formulation, or history of significant atopy
• Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or baseline that, in the opinion of the investigator, increases the risks associated with participating in the study
• Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
• Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase greater than 2 times the upper limit of normal (ULN) at screening and/or baseline
• Have known or ongoing psychiatric disorders considered clinically significant in the opinion of the investigator
• Have undergone any form of bariatric surgery
• Have fasting blood glucose levels greater than or equal to (≥) 7 millimoles per liter (mmol/L) [≥126 milligrams per deciliter (mg/dL)] at screening
• Have fasting triglycerides levels ≥300 mg/dL (3.4 mmol/L) at screening
• Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase (ALT) or aspartate aminotransferase (AST) levels greater than (>) 2.5 times the ULN at screening and/or baseline
• Have used or intend to use medications that promote weight loss, within 3 months prior to screening, for the duration of the study

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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48 participants in 6 patient groups, including a placebo group

Placebo (Single Dose, Cohorts 1-3)

Placebo Comparator group

Description:

Single dose of placebo matching LY2944876 administered subcutaneous (SC) on Day 1

Treatment:

Drug: Placebo

LY2944876 (Single Dose, Cohorts 1-3)

Experimental group

Description:

Single dose of 10 milligrams (mg) of LY2944876 administered SC on Day 1

Treatment:

Drug: LY2944876

Placebo (Multiple Dose, Cohort 4)

Placebo Comparator group

Description:

Placebo matching LY2944876 administered once daily SC on Days 1-7

Treatment:

Drug: Placebo

LY2944876 (Multiple Dose, Cohort 4)

Experimental group

Description:

40 mg LY2944876 administered once daily SC on Days 1-7

Treatment:

Drug: LY2944876

Placebo (Multiple, Cohort 5)

Placebo Comparator group

Description:

Placebo matching LY2944876 administered once daily SC on Days 1, 4, 6, 8, 10 and 12

Treatment:

Drug: Placebo

LY2944876 (Multiple Dose, Cohort 5, Titrated)

Experimental group

Description:

LY2944876 in titrated doses of 15 mg on Day 1, 30 mg on Day 4, up to 60 mg on Day 6, and up to 80 mg on Days 8, 10 and 12 administered once daily SC

Treatment:

Drug: LY2944876