Safety and Tolerability Study of MEDI0382 in Japanese Preobese or Obese Subjects With Type 2 Diabetes

• Status: Completed
• Trial end date: 2019-01-17
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2a study designed to assess the safety and tolerability of MEDI0382 titrated up to a dose level of 100, 200 or 300 µg from 50 µg vs Placebo across 48 days in Japanese subjects.

The study D5674C00001 can be conducted with a reasonable expectation of safety and tolerability in Japanese T2DM patients. The design of this study has taken into account the known benefits and risks of GLP-1 receptor agonists and glucagon receptor agonists as well as the translatable effects observed in nonclinical studies of MEDI0382.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca

Criteria

Inclusion Criteria:

• Individuals whose HbA1c range of 7.0% to 10.5% (inclusive) at screening.

• Individuals who are diagnosed with T2DM

• Individuals whose current condition at enrolment (Visit 1) is drug naïve

• BMI within the range of 24 - 40 kg/m2 (inclusive) at screening

Exclusion Criteria:

• Subjects with any of the following results at screening:

• Aspartate transaminase (AST) ≥ 2.5 × upper limit of normal (ULN)

• Alanine transaminase (ALT) ≥ 2.5 × ULN

• Total bilirubin (TBL) ≥ 2 × ULN

• Impaired renal function defined as estimated glomerular filtration rate (eGFR) ≤ 60 mL/minute/1.73 m2 at screening

• Participation in another clinical study with an investigational product administered in the last 30 days or 5 half-lives of the drug (whichever is longer) at the time of screening