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

A Phase 1/2, Randomized, Double-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Overweight and Obese Subjects With a History of Type 2 Diabetes Mellitus

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).

This is a randomized, double-blind, placebo controlled study designed to evaluate the efficacy, safety, and PK of MEDI0382 administered as multiple daily SC doses to participants with T2DM. Approximately one hundred and seven participants will be enrolled across 6 cohorts. In cohorts 1-3 the participants will be randomized to MEDI0382 or placebo (2:1). In Cohort 4, participants will be randomized to MEDI0382 or placebo (1:1). In cohort 5 and 6 participants will be randomized to MEDI0382 or placebo (3:1).

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