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