Overview

A Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics (PK) of MEDI0382 in Overweight and Obese Participants With Type 2 Diabetes Mellitus

Status:
Completed
Trial end date:
2017-02-24
Target enrollment:
0
Participant gender:
All
Summary
A Phase 1/2, multiple dose study with 6 cohorts of ascending doses designed to evaluate the efficacy, safety and pharmacokinetics (PK) of MEDI0382 in participants with Type 2 Diabetes Mellitus (T2DM).
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
MedImmune LLC
Criteria
Inclusion Criteria:

- Diagnosis of T2DM

- Must provide written informed consent

- Body mass index greater than (>) 27 and less than (<) 40 kg/m^2, inclusive

- Venous access suitable for multiple cannulations

- Vital signs within normal specified ranges

- Females must be non-lactating and non-childbearing potential

- Males must practice 2 effective contraceptive measures if sexually active

Exclusion Criteria:

- Any concurrent condition that in the opinion of the investigator would interfere with
the evaluation of the investigational product

- History or presence of gastrointestinal, renal, or hepatic disease or any other
condition known to interfere with absorption, distribution, metabolism, or excretion
of drugs

- History of cancer within the last 10 years, with the exception of non-melanoma skin
cancer

- Any clinically important illness (except for T2DM), medical/surgical procedure, or
trauma within 4 weeks prior to dosing

- Fasting glucose greater than or equal to (>=) 200 mg/dL

- Positive Hepatitis B, Hepatitis C or human immunodeficiency virus test or use of
antiretroviral medications at screening.

- Concurrent or previous use of a glucagon-like peptide 1 receptor agonist

- Current or previous use of systemic corticosteroids within the past 28 days prior to
screening

- Use of any medicinal products or herbal preparations licensed for control of body
weight or appetite is prohibited.

- Known or suspected history of alcohol or drug abuse within the past 3 years.

- Positive drug screen