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AZD4076 in Type 2 Diabetic Subjects With Non-Alcoholic Fatty Liver Disease.

NCT02826525 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2021-04-01

No results posted yet for this study

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.

Conditions

  • T2DM With NAFLD

Interventions

DRUG

AZD4076

Investigational product

DRUG

Placebo

Control

Sponsors & Collaborators

Principal Investigators

  • Linda Morrow, MD · ProSciento, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-18
Primary Completion
2019-10-11
Completion
2019-10-11

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02826525 on ClinicalTrials.gov