AZD4076 in Type 2 Diabetic Subjects With Non-Alcoholic Fatty Liver Disease.
Status:
Completed
Trial end date:
2019-10-11
Target enrollment:
Participant gender:
Summary
This is a phase I/IIa, randomized, single-blind, placebo-controlled, multiple-ascending dose
study conducted at a single site. The study plans to include up to approximately 46 evaluable
subjects with Type 2 Diabetes Mellitus (HbA1c 7-11%) and Non-Alcoholic Fatty Liver disease
(liver fat content > = 8%) on metformin monotherapy.
Three initial cohorts are planned:
- Cohort 1: 6 subjects receiving AZD4076 and 4 subjects receiving placebo
- Cohort 2: 12 subjects receiving AZD4076 and 10 subjects receiving placebo
- Cohort 3: 10 subjects receiving AZD4076 and 10 subjects receiving placebo, with the
possibility to add additional subjects if drop-out rates are higher than expected
Pending review by SRC, an additional 2 cohorts, each consisting of 18 evaluable subjects may
be included in the study.
The primary objectives of this clinical trial are to investigate the safety and tolerability
of AZD4076 following subcutaneous administration of multiple ascending doses; to assess the
effect of AZD4076 on whole body insulin sensitivity using hyperinsulinemic euglycemic clamp
with tracer technique; and to assess the effect of AZD4076 on liver fat content using
magnetic resonance imaging. Secondary objectives of this trial are to characterize multiple
dose PK of AZD4076 and its longmer and shortmer metabolites and assess the time required to
reach steady state and the degree of accumulation; to assess the efficacy of AZD4076 on
24-hour glucose; and to assess the effect of AZD4076 on homeostatic model assessment insulin
resistant (HOMA-IR) and Matsuda index.